Trial Outcomes & Findings for Comparative Effectiveness of Two Treatments for Veterans With PTSD (NCT NCT02586064)

Last Updated: 2021-07-07

Results Overview

Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

115 participants

Primary outcome timeframe

Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

Results posted on

2021-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	IPT-PTSD Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
Overall Study STARTED	61	54
Overall Study COMPLETED	43	26
Overall Study NOT COMPLETED	18	28

Reasons for withdrawal

Reasons for withdrawal
Measure	IPT-PTSD Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
Overall Study Other Obligations	6	6
Overall Study Other	3	7
Overall Study Never Started	3	3
Overall Study Lost Interest	1	4
Overall Study Miscellaneous Life Issues	0	5
Overall Study Infrequent Attendance	2	1
Overall Study Timed Out	2	0
Overall Study AUD relapse	0	2
Overall Study Legal Issue	1	0

Baseline Characteristics

Missing data from subjects at Baseline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Total n=109 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 16 • n=58 Participants	52 years STANDARD_DEVIATION 15 • n=51 Participants	49 years STANDARD_DEVIATION 16 • n=109 Participants
Sex: Female, Male Female	3 Participants n=58 Participants	3 Participants n=51 Participants	6 Participants n=109 Participants
Sex: Female, Male Male	55 Participants n=58 Participants	48 Participants n=51 Participants	103 Participants n=109 Participants
Race/Ethnicity, Customized White	39 Participants n=58 Participants	31 Participants n=51 Participants	70 Participants n=109 Participants
Race/Ethnicity, Customized Black	14 Participants n=58 Participants	17 Participants n=51 Participants	31 Participants n=109 Participants
Race/Ethnicity, Customized Other	5 Participants n=58 Participants	3 Participants n=51 Participants	8 Participants n=109 Participants
Clinician Assessment of PTSD Symptoms Version 5 (CAPS-5)	36.3 units on a scale STANDARD_DEVIATION 7.2 • n=58 Participants	34.8 units on a scale STANDARD_DEVIATION 7.4 • n=51 Participants	35.6 units on a scale STANDARD_DEVIATION 7.3 • n=109 Participants
PTSD Checklist Military Version 5 (PCL-M-5)	48.0 units on a scale STANDARD_DEVIATION 13.1 • n=57 Participants • Missing data from subjects at Baseline	45.8 units on a scale STANDARD_DEVIATION 12.7 • n=49 Participants • Missing data from subjects at Baseline	47.6 units on a scale STANDARD_DEVIATION 12.9 • n=106 Participants • Missing data from subjects at Baseline
Inventory of Interpersonal Functioning (IIP-32)	1.53 units on a scale STANDARD_DEVIATION 0.64 • n=58 Participants	1.43 units on a scale STANDARD_DEVIATION 0.56 • n=51 Participants	1.48 units on a scale STANDARD_DEVIATION 0.60 • n=109 Participants
Patient Health Questionnaire (PHQ-9)	15.2 units on a scale STANDARD_DEVIATION 6.4 • n=58 Participants	13.0 units on a scale STANDARD_DEVIATION 7.3 • n=51 Participants	14.2 units on a scale STANDARD_DEVIATION 6.9 • n=109 Participants
Generalized Anxiety Disorder (GAD-7)	12.1 units on a scale STANDARD_DEVIATION 5.8 • n=58 Participants	11.6 units on a scale STANDARD_DEVIATION 6.2 • n=51 Participants	11.9 units on a scale STANDARD_DEVIATION 6.0 • n=109 Participants
Multidimensional Scale of Perceived Social Support (MSPSS - Significant Other)	4.9 units on a scale STANDARD_DEVIATION 1.9 • n=58 Participants	5.5 units on a scale STANDARD_DEVIATION 1.2 • n=51 Participants	5.2 units on a scale STANDARD_DEVIATION 1.6 • n=109 Participants
Multidimensional Scale of Perceived Social Support (MSPSS) - Family	3.9 units on a scale STANDARD_DEVIATION 1.8 • n=58 Participants	4.6 units on a scale STANDARD_DEVIATION 1.7 • n=51 Participants	4.2 units on a scale STANDARD_DEVIATION 1.8 • n=109 Participants
Multidimensional Scale of Perceived Support (MSPSS) - Friends	3.9 units on a scale STANDARD_DEVIATION 1.6 • n=58 Participants	4.1 units on a scale STANDARD_DEVIATION 1.5 • n=51 Participants	4.0 units on a scale STANDARD_DEVIATION 1.6 • n=109 Participants
Concise Health Risk Tracking (CHRT) Scale - Total	27.6 units on a scale STANDARD_DEVIATION 10.3 • n=58 Participants	25.7 units on a scale STANDARD_DEVIATION 10.4 • n=51 Participants	26.8 units on a scale STANDARD_DEVIATION 10.3 • n=109 Participants
Concise Health Risk Tracking (CHRT) - Propensity	22.8 units on a scale STANDARD_DEVIATION 8.3 • n=58 Participants	21.4 units on a scale STANDARD_DEVIATION 8.8 • n=51 Participants	22.1 units on a scale STANDARD_DEVIATION 8.5 • n=109 Participants
Concise Health Risk Tracking (CHRT) - Suicidal Thoughts	4.8 units on a scale STANDARD_DEVIATION 2.6 • n=58 Participants	4.3 units on a scale STANDARD_DEVIATION 2.4 • n=51 Participants	4.5 units on a scale STANDARD_DEVIATION 2.5 • n=109 Participants
Work & Social Adjustment Scale (WSAS) Total	24.0 units on a scale STANDARD_DEVIATION 8.1 • n=58 Participants	22.6 units on a scale STANDARD_DEVIATION 9.6 • n=51 Participants	22.8 units on a scale STANDARD_DEVIATION 8.9 • n=109 Participants
WHO-QOL-BREF Item 1 Quality of Life	3.1 units on a scale STANDARD_DEVIATION 0.9 • n=58 Participants	3.3 units on a scale STANDARD_DEVIATION 1.0 • n=51 Participants	3.2 units on a scale STANDARD_DEVIATION 1.0 • n=109 Participants
WHO-QOL-BREF Item 2 Satisfaction with Health	2.7 units on a scale STANDARD_DEVIATION 1.0 • n=58 Participants	2.8 units on a scale STANDARD_DEVIATION 1.2 • n=51 Participants	2.8 units on a scale STANDARD_DEVIATION 1.1 • n=109 Participants

PRIMARY outcome

Timeframe: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

Population: Some Veterans skipped completing assessments

Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Clinician Administered PTSD Scale (CAPS-5) Baseline	36.3 score on a scale Standard Deviation 7.2	34.8 score on a scale Standard Deviation 7.4	1.52 score on a scale Standard Deviation 1.4
Change in Clinician Administered PTSD Scale (CAPS-5) End of Treatment	27.8 score on a scale Standard Deviation 9.8	28.2 score on a scale Standard Deviation 13.4	-0.43 score on a scale Standard Deviation 2.57
Change in Clinician Administered PTSD Scale (CAPS-5) Change	-8.1 score on a scale Standard Deviation 9.0	-5.5 score on a scale Standard Deviation 11.3	-2.56 score on a scale Standard Deviation 2.25
Change in Clinician Administered PTSD Scale (CAPS-5) 3 Month Post Treatment	27.6 score on a scale Standard Deviation 12.4	26.3 score on a scale Standard Deviation 14.7	1.30 score on a scale Standard Deviation 3.16
Change in Clinician Administered PTSD Scale (CAPS-5) 6 Month Post Treatment	25.6 score on a scale Standard Deviation 12.5	26.3 score on a scale Standard Deviation 14.3	-0.61 score on a scale Standard Deviation 3.05

PRIMARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

Population: Some Veterans skipped completing assessments

Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Inventory of Interpersonal Functioning (IIP-32) Baseline	1.53 units on a scale Standard Deviation 0.64	1.43 units on a scale Standard Deviation 0.56	0.11 units on a scale Standard Deviation 0.12
Change in Inventory of Interpersonal Functioning (IIP-32) 4 Week	1.5 units on a scale Standard Deviation 0.5	1.4 units on a scale Standard Deviation 0.7	0.13 units on a scale Standard Deviation 0.14
Change in Inventory of Interpersonal Functioning (IIP-32) 8 Week	1.3 units on a scale Standard Deviation 0.5	1.4 units on a scale Standard Deviation 0.7	-0.12 units on a scale Standard Deviation 0.15
Change in Inventory of Interpersonal Functioning (IIP-32) End of Treatment	1.33 units on a scale Standard Deviation 0.63	1.21 units on a scale Standard Deviation 0.66	0.12 units on a scale Standard Deviation 0.14
Change in Inventory of Interpersonal Functioning (IIP-32) Change	-0.22 units on a scale Standard Deviation 0.57	-0.15 units on a scale Standard Deviation 0.63	-0.06 units on a scale Standard Deviation 0.13
Change in Inventory of Interpersonal Functioning (IIP-32) 3 Month Post Treatment	1.2 units on a scale Standard Deviation 0.60	1.1 units on a scale Standard Deviation 0.60	0.17 units on a scale Standard Deviation 0.14
Change in Inventory of Interpersonal Functioning (IIP-32) 6 Month Post Treatment	1.4 units on a scale Standard Deviation 0.60	1.1 units on a scale Standard Deviation 0.60	0.24 units on a scale Standard Deviation 0.14

SECONDARY outcome

Population: Some participants skipped assessments

Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=57 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=49 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=106 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in PTSD Checklist for DSM-5 Military Version (PCL-M) Baseline	48.0 score on a scale Standard Deviation 13.1	45.8 score on a scale Standard Deviation 12.7	2.15 score on a scale Standard Deviation 2.52
Change in PTSD Checklist for DSM-5 Military Version (PCL-M) End of Treatment	33.7 score on a scale Standard Deviation 15.9	35.5 score on a scale Standard Deviation 19.8	-1.82 score on a scale Standard Deviation 3.96
Change in PTSD Checklist for DSM-5 Military Version (PCL-M) Change	-12.8 score on a scale Standard Deviation 14.0	-11.0 score on a scale Standard Deviation 18.8	-1.75 score on a scale Standard Deviation 3.69
Change in PTSD Checklist for DSM-5 Military Version (PCL-M) 3-Month Follow Up	38.4 score on a scale Standard Deviation 17.4	36.2 score on a scale Standard Deviation 21.2	2.12 score on a scale Standard Deviation 4.46
Change in PTSD Checklist for DSM-5 Military Version (PCL-M) 6-Month Follow Up	36.1 score on a scale Standard Deviation 17.9	37.4 score on a scale Standard Deviation 20.0	-1.35 score on a scale Standard Deviation 4.38

SECONDARY outcome

Population: Some Veterans skipped completing assessments

Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Patient Health Questionnaire (PHQ) Baseline	15.2 score on a scale Standard Deviation 6.4	13.0 score on a scale Standard Deviation 7.3	2.15 score on a scale Standard Deviation 1.32
Change in Patient Health Questionnaire (PHQ) Week 4	13.9 score on a scale Standard Deviation 5.3	12.9 score on a scale Standard Deviation 7.2	1.0 score on a scale Standard Deviation 1.39
Change in Patient Health Questionnaire (PHQ) Week 8	11.1 score on a scale Standard Deviation 5.2	11.6 score on a scale Standard Deviation 6.9	-0.50 score on a scale Standard Deviation 1.52
Change in Patient Health Questionnaire (PHQ) End of Treatment	11.8 score on a scale Standard Deviation 6.5	10.3 score on a scale Standard Deviation 7.1	1.47 score on a scale Standard Deviation 1.51
Change in Patient Health Questionnaire (PHQ) Change	-3.1 score on a scale Standard Deviation 7.5	-2.4 score on a scale Standard Deviation 7.0	-0.74 score on a scale Standard Deviation 1.63
Change in Patient Health Questionnaire (PHQ) 3 Month	12.6 score on a scale Standard Deviation 5.7	10.3 score on a scale Standard Deviation 7.3	2.25 score on a scale Standard Deviation 1.51
Change in Patient Health Questionnaire (PHQ) 6 Month	13.2 score on a scale Standard Deviation 6.1	11.1 score on a scale Standard Deviation 7.2	2.09 score on a scale Standard Deviation 1.54

SECONDARY outcome

Population: Some Veterans skipped completing assessments

Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, \& 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other Baseline	4.9 score on a scale Standard Deviation 1.9	5.5 score on a scale Standard Deviation 1.2	-0.56 score on a scale Standard Deviation 0.31
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other End of Treatment	4.9 score on a scale Standard Deviation 2.0	5.7 score on a scale Standard Deviation 1.5	-0.74 score on a scale Standard Deviation 0.40
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other Change	-0.13 score on a scale Standard Deviation 1.33	-0.18 score on a scale Standard Deviation 0.99	0.05 score on a scale Standard Deviation 0.27
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other 3 Month Post Tx	4.9 score on a scale Standard Deviation 1.7	6.0 score on a scale Standard Deviation 1.4	-1.10 score on a scale Standard Deviation 0.36
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other 6 Month Post Tx	5.2 score on a scale Standard Deviation 1.6	6.0 score on a scale Standard Deviation 1.3	-0.76 score on a scale Standard Deviation 0.34

SECONDARY outcome

Population: Some Veterans skipped completing assessments

Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, \& 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family Baseline	3.9 score on a scale Standard Deviation 1.8	4.6 score on a scale Standard Deviation 1.7	-0.66 score on a scale Standard Deviation 0.33
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family End of Treatment	4.4 score on a scale Standard Deviation 1.6	5.1 score on a scale Standard Deviation 1.7	-0.75 score on a scale Standard Deviation 0.36
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family Change	0.34 score on a scale Standard Deviation 1.54	0.27 score on a scale Standard Deviation 1.76	0.07 score on a scale Standard Deviation 0.36
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family 3 Month Post Tx	4.0 score on a scale Standard Deviation 1.7	5.5 score on a scale Standard Deviation 1.2	-1.48 score on a scale Standard Deviation 0.34
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family 6 Month Post Tx	4.5 score on a scale Standard Deviation 1.7	5.0 score on a scale Standard Deviation 1.8	-0.56 score on a scale Standard Deviation 0.40

SECONDARY outcome

Population: Some Veterans skipped completing assessments

Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, \& 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends Baseline	3.9 score on a scale Standard Deviation 1.6	4.1 score on a scale Standard Deviation 1.5	-0.23 score on a scale Standard Deviation 0.30
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends End of Treatment	4.4 score on a scale Standard Deviation 1.7	4.3 score on a scale Standard Deviation 1.8	0.14 score on a scale Standard Deviation 0.38
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends Change	0.5 score on a scale Standard Deviation 1.6	0.3 score on a scale Standard Deviation 1.8	0.20 score on a scale Standard Deviation 0.39
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends 3 Month Post Tx	3.9 score on a scale Standard Deviation 1.5	4.4 score on a scale Standard Deviation 1.7	-0.57 score on a scale Standard Deviation 0.37
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends 6 Month Post Tx	4.3 score on a scale Standard Deviation 1.6	4.2 score on a scale Standard Deviation 1.8	0.10 score on a scale Standard Deviation 0.38

SECONDARY outcome

Population: Some Veterans skipped assessments

Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Concise Health Risk Tracking Scale - Total (CHRT) Baseline	27.6 score on a scale Standard Deviation 10.3	25.7 score on a scale Standard Deviation 10.4	1.87 score on a scale Standard Deviation 1.98
Change in Concise Health Risk Tracking Scale - Total (CHRT) End of Treatment	25.4 score on a scale Standard Deviation 8.9	21.9 score on a scale Standard Deviation 10.9	3.49 score on a scale Standard Deviation 2.13
Change in Concise Health Risk Tracking Scale - Total (CHRT) Change	-2.7 score on a scale Standard Deviation 8.9	-3.5 score on a scale Standard Deviation 11.3	0.72 score on a scale Standard Deviation 2.16
Change in Concise Health Risk Tracking Scale - Total (CHRT) 3-Month Follow Up	27.1 score on a scale Standard Deviation 9.9	22.1 score on a scale Standard Deviation 9.8	5.04 score on a scale Standard Deviation 2.28
Change in Concise Health Risk Tracking Scale - Total (CHRT) 6-Month Follow Up	26.3 score on a scale Standard Deviation 9.7	23.5 score on a scale Standard Deviation 10.3	2.8 score on a scale Standard Deviation 2.27

SECONDARY outcome

Population: Some Veterans skipped assessments

The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity Baseline	22.8 score on a scale Standard Deviation 8.3	21.4 score on a scale Standard Deviation 8.8	1.40 score on a scale Standard Deviation 1.63
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity End of Treatment	20.6 score on a scale Standard Deviation 7.6	17.9 score on a scale Standard Deviation 9.4	2.68 score on a scale Standard Deviation 1.82
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity Change	-2.6 score on a scale Standard Deviation 7.3	-3.2 score on a scale Standard Deviation 9.3	0.64 score on a scale Standard Deviation 1.78
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity 3-Month Follow Up	21.9 score on a scale Standard Deviation 7.9	18.0 score on a scale Standard Deviation 8.6	3.91 score on a scale Standard Deviation 1.89
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity 6-Month Follow Up	21.4 score on a scale Standard Deviation 7.7	18.9 score on a scale Standard Deviation 8.8	2.46 score on a scale Standard Deviation 1.87

SECONDARY outcome

Population: Some Veterans missed assessments

The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts Baseline	4.8 score on a scale Standard Deviation 2.6	4.3 score on a scale Standard Deviation 2.4	0.47 score on a scale Standard Deviation 0.48
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts End of Treatment	4.8 score on a scale Standard Deviation 2.4	4.0 score on a scale Standard Deviation 2.3	0.81 score on a scale Standard Deviation 0.50
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts Change	-0.16 score on a scale Standard Deviation 2.33	-0.24 score on a scale Standard Deviation 2.83	0.08 score on a scale Standard Deviation 0.55
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts 3-Month Follow Up	5.2 score on a scale Standard Deviation 2.9	4.1 score on a scale Standard Deviation 2.0	1.13 score on a scale Standard Deviation 0.57
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts 6-Month Follow Up	4.9 score on a scale Standard Deviation 2.5	4.6 score on a scale Standard Deviation 2.5	0.33 score on a scale Standard Deviation 0.57

SECONDARY outcome

Population: Some Veterans missed completing assessments

Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in Work and Social Adjustment Scale (WSAS) Baseline	24.0 score on a scale Standard Deviation 8.1	22.6 score on a scale Standard Deviation 9.6	2.40 score on a scale Standard Deviation 1.70
Change in Work and Social Adjustment Scale (WSAS) End of Treatment	20.4 score on a scale Standard Deviation 10.8	15.8 score on a scale Standard Deviation 11.6	4.58 score on a scale Standard Deviation 2.41
Change in Work and Social Adjustment Scale (WSAS) Change	-3.5 score on a scale Standard Deviation 9.7	-5.1 score on a scale Standard Deviation 9.9	1.58 score on a scale Standard Deviation 2.12
Change in Work and Social Adjustment Scale (WSAS) 3 Month Post Tx	23.4 score on a scale Standard Deviation 9.2	15.5 score on a scale Standard Deviation 11.5	7.96 score on a scale Standard Deviation 2.37
Change in Work and Social Adjustment Scale (WSAS) 6 Month Post Tx	23.4 score on a scale Standard Deviation 9.3	15.7 score on a scale Standard Deviation 11.6	7.73 score on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.

Population: Some Veterans missed completing assessments

Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life Baseline	3.1 score on a scale Standard Deviation 0.9	3.3 score on a scale Standard Deviation 1.0	-0.21 score on a scale Standard Deviation 0.18
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life End of Treatment	3.2 score on a scale Standard Deviation 0.9	3.2 score on a scale Standard Deviation 1.0	0.05 score on a scale Standard Deviation 0.20
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life Change	0.04 score on a scale Standard Deviation 0.91	-0.21 score on a scale Standard Deviation 0.98	0.25 score on a scale Standard Deviation 0.21

SECONDARY outcome

Population: Some Veterans skipped completing assessments

Measure of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health Baseline	2.7 score on a scale Standard Deviation 1.0	2.8 score on a scale Standard Deviation 1.2	-0.17 score on a scale Standard Deviation 0.21
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health End of Treatment	2.6 score on a scale Standard Deviation 1.0	2.9 score on a scale Standard Deviation 1.1	-0.29 score on a scale Standard Deviation 0.23
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health Change	-0.12 score on a scale Standard Deviation 1.18	0.06 score on a scale Standard Deviation 1.23	-0.18 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Baseline to 6 months posttreatment

Population: Some Veterans skipped completing assessments

Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	IPT-PTSD n=58 Participants Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=51 Participants Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).	Difference Mean n=109 Participants Difference between mean of IPT-PTSD and Prolonged Exposure
GAD - 7 Generalized Anxiety Disorder Week 8	9.6 score on a scale Standard Deviation 5.5	10.5 score on a scale Standard Deviation 6.4	-0.84 score on a scale Standard Deviation 1.53
GAD - 7 Generalized Anxiety Disorder Baseline	12.1 score on a scale Standard Deviation 5.8	11.6 score on a scale Standard Deviation 6.2	0.44 score on a scale Standard Deviation 1.15
GAD - 7 Generalized Anxiety Disorder Week 4	12.2 score on a scale Standard Deviation 4.9	12.1 score on a scale Standard Deviation 5.5	0.06 score on a scale Standard Deviation 1.17
GAD - 7 Generalized Anxiety Disorder End of Treatment	9.7 score on a scale Standard Deviation 5.7	9.0 score on a scale Standard Deviation 5.8	0.65 score on a scale Standard Deviation 1.29
GAD - 7 Generalized Anxiety Disorder Change	-2.3 score on a scale Standard Deviation 5.1	-2.6 score on a scale Standard Deviation 6.3	0.25 score on a scale Standard Deviation 1.25
GAD - 7 Generalized Anxiety Disorder 3 Month Follow Up	11.1 score on a scale Standard Deviation 6.0	9.6 score on a scale Standard Deviation 6.0	1.49 score on a scale Standard Deviation 1.43
GAD - 7 Generalized Anxiety Disorder 6 Month Follow Up	11.0 score on a scale Standard Deviation 5.3	9.2 score on a scale Standard Deviation 5.6	1.80 score on a scale Standard Deviation 1.27

Adverse Events

IPT-PTSD

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Prolonged Exposure

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IPT-PTSD n=61 participants at risk Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions Interpersonal Therapy for PTSD: Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.	Prolonged Exposure n=54 participants at risk Exposure based intervention including exposure to memories and avoided places and activities Prolonged Exposure: Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
Psychiatric disorders Inpatient Hospitalization - Alcohol	4.9% 3/61 • Number of events 3 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.	3.7% 2/54 • Number of events 2 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.
Psychiatric disorders Inpatient Hospitalization-Depression/Suicidal Ideation	3.3% 2/61 • Number of events 2 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.	0.00% 0/54 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.
Injury, poisoning and procedural complications Domestic Violence issue - Sustained minor injury	3.3% 2/61 • Number of events 2 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.	0.00% 0/54 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.
Psychiatric disorders Inpatient Hospitalization - Drugs	0.00% 0/61 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.	1.9% 1/54 • Number of events 1 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.
Psychiatric disorders Inpatient Hospitalization-Schizoaffective Disorder	1.6% 1/61 • Number of events 1 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.	0.00% 0/54 • Baseline to 6 months post-treatment, an average of 9 months Definitions do not differ.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tracie Shea

Providence VA Medical Center

Phone: 401-273-7100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place