Trial Outcomes & Findings for PTSD Treatment for Incarcerated Men and Women: NIMH (NCT NCT05168267)
NCT ID: NCT05168267
Last Updated: 2025-04-08
Results Overview
Intervention feasibility measured primarily by participant retention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
up to 6 weeks (by the end of 12th session)
Results posted on
2025-04-08
Participant Flow
89 participants were consented, 79 were deemed eligible, 69 started group.
Participant milestones
| Measure |
Women's Facility Cognitive Processing Therapy (CPT)
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Men's Facility Cognitive Processing Therapy (CPT)
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
Screened
|
55
|
47
|
|
Overall Study
Consented to Participate
|
46
|
43
|
|
Overall Study
Eligible to Participate
|
43
|
36
|
|
Overall Study
Started Intervention
|
34
|
34
|
|
Overall Study
Participants Providing Data at 1-week Follow up
|
31
|
32
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Women's Facility Cognitive Processing Therapy (CPT)
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Men's Facility Cognitive Processing Therapy (CPT)
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Withdrawn by Therapist
|
1
|
1
|
|
Overall Study
Left Facility
|
1
|
0
|
Baseline Characteristics
Race was measured by facility (men \& women)
Baseline characteristics by cohort
| Measure |
Women's Facility Cognitive Processing Therapy (CPT) Group
n=35 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Women's Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes homework assignments. For this study, CPT will be conducted in groups.
|
Men's Facility Cognitive Processing Therapy (CPT)
n=34 Participants
Arm = Cognitive Processing Therapy (CPT)
Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.09 years
STANDARD_DEVIATION 10.78 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
38.12 years
STANDARD_DEVIATION 11.23 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Womens Facility · American Indian or Alaska Native
|
2 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
0 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
2 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · Asian
|
0 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
1 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
1 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
0 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
0 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · Black or African American
|
3 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
14 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
17 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · White
|
28 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
17 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
45 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · More than one race
|
1 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
2 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
3 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Race (NIH/OMB)
Womens Facility · Unknown or Not Reported
|
1 Participants
n=99 Participants • Race was measured by facility (men \& women)
|
0 Participants
n=107 Participants • Race was measured by facility (men \& women)
|
1 Participants
n=206 Participants • Race was measured by facility (men \& women)
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
34 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
PCL-5
|
50.49 units on a scale
STANDARD_DEVIATION 12.29 • n=99 Participants
|
47.26 units on a scale
STANDARD_DEVIATION 10.31 • n=107 Participants
|
48.90 units on a scale
STANDARD_DEVIATION 11.39 • n=206 Participants
|
|
Beck Anxiety Inventory (BAI)
|
22.57 score on a scale
STANDARD_DEVIATION 9.72 • n=99 Participants
|
25.03 score on a scale
STANDARD_DEVIATION 9.32 • n=107 Participants
|
23.72 score on a scale
STANDARD_DEVIATION 9.54 • n=206 Participants
|
|
Beck Depression Inventory 2 (BDI-II)
|
30.14 score on a scale
STANDARD_DEVIATION 11.41 • n=99 Participants
|
29.94 score on a scale
STANDARD_DEVIATION 9.17 • n=107 Participants
|
30.04 score on a scale
STANDARD_DEVIATION 10.29 • n=206 Participants
|
PRIMARY outcome
Timeframe: up to 6 weeks (by the end of 12th session)Intervention feasibility measured primarily by participant retention
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=34 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=35 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Number and Percentage of Participants That Attend All Offered Cognitive Processing Therapy Sessions
|
32 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: baseline (one week prior to intervention), post-intervention (up to 13 weeks on study)Population: Participants with baseline and post-intervention data - the negative numbers indicate a decrease in symptom severity of the intervention period.
PTSD symptom severity is measured by PCL-5 questionnaire (scores from 0, no symptoms, to 80, high severity); primary measure of intervention efficacy. The negative numbers indicate a decrease in symptom severity of the intervention period.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=32 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=31 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Change in Self-reported PTSD Symptoms (PCL-5)
|
-12.94 score on a scale
Interval -43.0 to -12.94
|
-19.07 score on a scale
Interval -58.0 to -13.0
|
PRIMARY outcome
Timeframe: Post (1 week post-intervention, up to 13 weeks on study)Population: Participants lost to follow up
Client treatment acceptability and satisfaction is measured by mean scores on the CSQ-8; Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=32 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=29 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Mean Scores on the CSQ-8 (Client Satisfaction Questionnaire)
|
25.7 units on a scale
Standard Deviation 4.74
|
28.48 units on a scale
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: baseline (one week prior to intervention)Population: Screened participants (one week prior to intervention)
Assesses for participant eligibility as secondary measure of intervention feasibility.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=47 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=55 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Percentage of Individuals That Meet Study Inclusion Criteria
|
36 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: up to start of interventionPopulation: Eligible participants
Assesses for participant interest as secondary measure of intervention feasibility.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=36 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=43 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Percentage of Eligible Individuals Enrolled in the Study
|
34 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: By the end of final treatment session (up to 12 weeks)Assesses for participant compliance: participation during session as secondary measure of intervention feasibility.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=34 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=35 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Number of Participants Attending Greater Than or Equal to 75% of Sessions (Attendance)
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: By the end of final treatment session (up to 12 weeks)Population: Retained participants (up to 12 weeks on study)
Assesses for participant compliance: extent to which participants complied with treatment skill practice
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=32 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=31 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Percentage of Retained Participants That Completed at Least >80% of Assigned Worksheets
|
22 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: By the end of final treatment session (up to 12 weeks)Population: CPT session elements
Higher percentage indicates better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention feasibility. For each 12-session intervention, 2 sessions were audio recorded and rated.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=60 CPT session elements
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=54 CPT session elements
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Percentage of Session Elements That Were Rated "Present" (Versus "Absent") by a Clinical Supervisor
|
85.96 Percentage of session elements present
|
87.72 Percentage of session elements present
|
SECONDARY outcome
Timeframe: By the end of final treatment session (up to 12 weeks)Population: Both unique and non-unique but essential items were analyzed. Unique Items = therapeutic tasks specific to delivery of CPT; Essential Items = therapeutic tasks not specific to CPT but essential to the therapeutic process
Higher ratings indicate higher-quality session element (scores 1-5; 1="poor", 5="excellent) by the clinical supervisors. Competence ratings will be collected for two audio recorded group sessions out of each 12-session intervention. Assesses for therapist compliance as secondary measure of intervention feasibility.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=60 CPT session elements
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=54 CPT session elements
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist
Unique Items
|
4.35 CPT session elements
Standard Deviation .5
|
4.67 CPT session elements
Standard Deviation .57
|
|
Ratings 1-5 by Clinical Supervisors on Quality of Session Elements Delivered by Therapist
Essential Items
|
4.36 CPT session elements
Standard Deviation .53
|
4.77 CPT session elements
Standard Deviation .43
|
SECONDARY outcome
Timeframe: post (one week post-intervention, up to 13 weeks on study)Question 9 on the BDI-II assesses for suicidal ideation. A score of 2 (I would like to kill myself) or 3 (I would kill myself if I had the chance; the highest score) indicate heightened levels of suicidal ideation. Participants who endorse current suicidal ideation will be referred to mental health services within the institution. Assesses for participant safety as secondary measure of intervention feasibility.
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=34 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=35 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Number of Participants Reporting Increased Suicidality Over the Course of Treatment (Endorsing 2 or Higher on Question #9 of BDI-II)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 month follow up (up to 25 weeks)We will collect information on participant dropout reasons to understand reasons for discontinuation
Outcome measures
| Measure |
Men's Facility Cognitive Processing Therapy (CPT)
n=34 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Women's Facility Cognitive Processing Therapy (CPT)
n=35 Participants
Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Reasons for Participant Discontinuation
Transferred Facilities
|
0 Participants
|
1 Participants
|
|
Reasons for Participant Discontinuation
Scheduling Issues
|
0 Participants
|
1 Participants
|
|
Reasons for Participant Discontinuation
Group "Not Helpful"
|
0 Participants
|
1 Participants
|
|
Reasons for Participant Discontinuation
Work
|
2 Participants
|
0 Participants
|
|
Reasons for Participant Discontinuation
Withdrawn by study clinician
|
2 Participants
|
0 Participants
|
Adverse Events
Women's Facility Cognitive Processing Therapy (CPT)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Men's Facility Cognitive Processing Therapy (CPT)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Women's Facility Cognitive Processing Therapy (CPT)
n=35 participants at risk
Arm = Cognitive Processing Therapy (CPT)
Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
Men's Facility Cognitive Processing Therapy (CPT)
n=34 participants at risk
Arm = Cognitive Processing Therapy (CPT)
Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD
Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups.
|
|---|---|---|
|
Psychiatric disorders
Passive Suicidal Ideation
|
0.00%
0/35 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Psychiatric disorders
Increased PTSD symptoms
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Psychiatric disorders
Increase in depressive symptoms
|
0.00%
0/35 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Social circumstances
Segregated Housing Placement / Rule Violation
|
8.6%
3/35 • Number of events 3 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
8.8%
3/34 • Number of events 3 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Cardiac disorders
Medical Event
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
14.7%
5/34 • Number of events 6 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Psychiatric disorders
Increased emotional distress
|
5.7%
2/35 • Number of events 2 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
0.00%
0/34 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
|
Social circumstances
Social Circusmtances
|
0.00%
0/35 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
|
Additional Information
Michael Koenigs
University of Wisconsin Madison - Incarceration and Mental Health Lab
Phone: (608) 263-1679
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place