Trial Outcomes & Findings for Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education (NCT NCT01022203)
NCT ID: NCT01022203
Last Updated: 2016-11-16
Results Overview
Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
Results posted on
2016-11-16
Participant Flow
Twenty-four subjects (12 couples) were lost or withdrew from the study after providing consent and participating in the pretreatment assessment, but before randomization to one of the two treatment conditions (Structured Approach Therapy or PTSD Family Education).
Participant milestones
| Measure |
Structured Approach Therapy
Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD
|
PTSD Family Education
Educational Intervention.
PTSD Family Education: Education about PTSD for couples.
|
|---|---|---|
|
PreTreatment Assessment
STARTED
|
58
|
56
|
|
PreTreatment Assessment
COMPLETED
|
58
|
56
|
|
PreTreatment Assessment
NOT COMPLETED
|
0
|
0
|
|
Post Treatment Assessment
STARTED
|
58
|
56
|
|
Post Treatment Assessment
COMPLETED
|
44
|
42
|
|
Post Treatment Assessment
NOT COMPLETED
|
14
|
14
|
|
Follow-Up Assessment
STARTED
|
44
|
42
|
|
Follow-Up Assessment
COMPLETED
|
42
|
40
|
|
Follow-Up Assessment
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Structured Approach Therapy
Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD
|
PTSD Family Education
Educational Intervention.
PTSD Family Education: Education about PTSD for couples.
|
|---|---|---|
|
Post Treatment Assessment
Withdrawal by Subject
|
12
|
12
|
|
Post Treatment Assessment
Physician Decision
|
2
|
0
|
|
Post Treatment Assessment
Adverse Event
|
0
|
2
|
|
Follow-Up Assessment
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Baseline characteristics by cohort
| Measure |
Arm 1
n=58 Participants
Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD
|
Arm 2
n=56 Participants
Educational Intervention.
PTSD Family Education: Education about PTSD for couples.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
Veterans Age
|
33.71 years
STANDARD_DEVIATION 7.01 • n=99 Participants
|
32.55 years
STANDARD_DEVIATION 6.16 • n=107 Participants
|
33.12 years
STANDARD_DEVIATION 6.56 • n=206 Participants
|
|
Age, Continuous
Partners Age
|
32.25 years
STANDARD_DEVIATION 7.89 • n=99 Participants
|
32.17 years
STANDARD_DEVIATION 7.68 • n=107 Participants
|
32.21 years
STANDARD_DEVIATION 7.72 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
112 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
|
|
Region of Enrollment
United States
|
58 participants
n=99 Participants
|
56 participants
n=107 Participants
|
114 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).Population: Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.
Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).
Outcome measures
| Measure |
Structured Approach Therapy
n=44 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
PTSD Family Education
n=42 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
|---|---|---|
|
Psychological Functioning
Vet Pre-treatment Clinician Administered PTSD Scal
|
82.93 units on a scale
Standard Deviation 3.31
|
82.93 units on a scale
Standard Deviation 3.31
|
|
Psychological Functioning
Vet Pre-treatment PTSD Checklist
|
60.84 units on a scale
Standard Deviation 2.12
|
60.81 units on a scale
Standard Deviation 2.17
|
|
Psychological Functioning
Vet Post-treatment Clinician Administered PTSD
|
48.33 units on a scale
Standard Deviation 3.71
|
72.59 units on a scale
Standard Deviation 3.79
|
|
Psychological Functioning
Vet Post-treatment PTSD Checklist
|
42.16 units on a scale
Standard Deviation 2.38
|
53.91 units on a scale
Standard Deviation 2.48
|
|
Psychological Functioning
Vet Followup Clinician Administered PTSD Scale
|
44.64 units on a scale
Standard Deviation 3.78
|
71.93 units on a scale
Standard Deviation 3.86
|
|
Psychological Functioning
Vet Followup PTSD Checklist
|
39.54 units on a scale
Standard Deviation 2.48
|
51.77 units on a scale
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).Population: Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.
Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.
Outcome measures
| Measure |
Structured Approach Therapy
n=44 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
PTSD Family Education
n=42 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
|---|---|---|
|
Relationship Functioning
Vet Pre-Trtmt Dyadic Adjustment Scale
|
93.34 units on a scale
Standard Deviation 3.53
|
101.82 units on a scale
Standard Deviation 3.60
|
|
Relationship Functioning
Vet Post-Trtmt Dyadic Adjustment Scale
|
105.18 units on a scale
Standard Deviation 3.84
|
101.77 units on a scale
Standard Deviation 3.87
|
|
Relationship Functioning
Vet Followup Dyadic Adjustment Scale
|
106.76 units on a scale
Standard Deviation 3.84
|
101.95 units on a scale
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).Population: Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.
Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).
Outcome measures
| Measure |
Structured Approach Therapy
n=44 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
PTSD Family Education
n=42 Participants
Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
|
|---|---|---|
|
Emotion Regulation
Vet Pre-Trtmt Difficulties in Emotion Regulation
|
106.6 units on a scale
Standard Deviation 23.9
|
106.4 units on a scale
Standard Deviation 22.4
|
|
Emotion Regulation
Vet Post-Trtmt Difficulties in Emotion Regulation
|
88.7 units on a scale
Standard Deviation 24.4
|
106.4 units on a scale
Standard Deviation 22.4
|
|
Emotion Regulation
VetFollowup Difficulty in Emotion Regulation Scale
|
87.29 units on a scale
Standard Deviation 26.84
|
105.75 units on a scale
Standard Deviation 25.99
|
Adverse Events
Structured Approach Therapy (SAT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTSD Family Education (PFE)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Structured Approach Therapy (SAT)
n=58 participants at risk
Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.
Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication.
|
PTSD Family Education (PFE)
n=56 participants at risk
Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.
PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included.
|
|---|---|---|
|
Psychiatric disorders
Domestic violence
|
0.00%
0/58
|
3.6%
2/56 • Number of events 2
|
Additional Information
Frederic Sautter, Ph.D.
Southeast Louisiana Veterans Health Care System (SLVHCS)
Phone: 504-988-3026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place