Stress Disorders, Post-Traumatic
Conditions
Keywords
Couples Therapy, PTSD
Brief summary
The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD, called Structured Approach Therapy, to decrease PTSD and improve the marital and social functioning of Iraqi war Veterans and their partners. The effectiveness of couples therapy will be compared with the effectiveness of a couple-based educational intervention.
Detailed description
The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy, by randomly assigning 57 Iraqi war Veterans and their partners to either a 12-15 session Structured Approach Therapy program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two experimental conditions will be ascertained by obtaining measures of PTSD severity from Veterans and measures of relationship functioning and emotion regulation from Veterans and their partners prior to treatment, immediately after treatment, and three months after the last treatment session. The investigators will test the hypothesis that couples participating in Structured Approach Therapy will show significantly greater improvements on all three clinical outcome measures than couples participating in PTSD Family Education. These hypotheses will be tested with an intent-to-treat analysis using general linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcome, separately for the Veterans and their partners. The objectives of the Structured Approach Therapy intervention are to decrease PTSD severity, improve relationship and family functioning, and decrease problems in emotion regulation in a group of young Veterans at risk for developing chronic PTSD, and to reduce emotional distress and relationship and family problems in their partners.
Interventions
OTHERPTSD Family Education
The PTSD Family Education intervention 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.
BEHAVIORALStructured Approach Therapy
The Structured Approach Therapy 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.
Sponsors
Southeast Louisiana Veterans Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Exposure to at least one combat-related stressful event during combat deployment, * Current diagnostic criteria for PTSD for that event, and * Veteran is in a committed relationship and living with an opposite sex partner for at least six months.
Exclusion criteria
* Current psychotic symptoms in either partner, * Current diagnosis of alcohol or drug dependence in either partner, * History of recent physical assault/abuse, * Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy) * Currently receiving couples therapy or family therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Functioning | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Functioning | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). | 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. |
| Emotion Regulation | Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment). | 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). |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Couple's Therapy Intervention
Structured Approach Therapy: Couple's Therapy for PTSD | 58 |
| Arm 2 Educational Intervention.
PTSD Family Education: Education about PTSD for couples. | 56 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up Assessment | Lost to Follow-up | 2 | 2 |
| Post Treatment Assessment | Adverse Event | 0 | 2 |
| Post Treatment Assessment | Physician Decision | 2 | 0 |
| Post Treatment Assessment | Withdrawal by Subject | 12 | 12 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 56 Participants | 114 Participants |
| Age, Continuous Partners Age | 32.25 years STANDARD_DEVIATION 7.89 | 32.17 years STANDARD_DEVIATION 7.68 | 32.21 years STANDARD_DEVIATION 7.72 |
| Age, Continuous Veterans Age | 33.71 years STANDARD_DEVIATION 7.01 | 32.55 years STANDARD_DEVIATION 6.16 | 33.12 years STANDARD_DEVIATION 6.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 56 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 58 participants | 56 participants | 114 participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 29 Participants | 28 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 2 / 56 |
| serious Total, serious adverse events | 0 / 58 | 0 / 56 |
Outcome results
Primary
Psychological Functioning
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Approach Therapy | Psychological Functioning | Vet Pre-treatment Clinician Administered PTSD Scal | 82.93 units on a scale | Standard Deviation 3.31 |
| Structured Approach Therapy | Psychological Functioning | Vet Post-treatment Clinician Administered PTSD | 48.33 units on a scale | Standard Deviation 3.71 |
| Structured Approach Therapy | Psychological Functioning | Vet Followup Clinician Administered PTSD Scale | 44.64 units on a scale | Standard Deviation 3.78 |
| Structured Approach Therapy | Psychological Functioning | Vet Pre-treatment PTSD Checklist | 60.84 units on a scale | Standard Deviation 2.12 |
| Structured Approach Therapy | Psychological Functioning | Vet Followup PTSD Checklist | 39.54 units on a scale | Standard Deviation 2.48 |
| Structured Approach Therapy | Psychological Functioning | Vet Post-treatment PTSD Checklist | 42.16 units on a scale | Standard Deviation 2.38 |
| PTSD Family Education | Psychological Functioning | Vet Followup PTSD Checklist | 51.77 units on a scale | Standard Deviation 2.53 |
| PTSD Family Education | Psychological Functioning | Vet Post-treatment PTSD Checklist | 53.91 units on a scale | Standard Deviation 2.48 |
| PTSD Family Education | Psychological Functioning | Vet Pre-treatment Clinician Administered PTSD Scal | 82.93 units on a scale | Standard Deviation 3.31 |
| PTSD Family Education | Psychological Functioning | Vet Pre-treatment PTSD Checklist | 60.81 units on a scale | Standard Deviation 2.17 |
| PTSD Family Education | Psychological Functioning | Vet Post-treatment Clinician Administered PTSD | 72.59 units on a scale | Standard Deviation 3.79 |
| PTSD Family Education | Psychological Functioning | Vet Followup Clinician Administered PTSD Scale | 71.93 units on a scale | Standard Deviation 3.86 |
Comparison: Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.p-value: <0.0001Mixed Models Analysis
Secondary
Emotion Regulation
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Approach Therapy | Emotion Regulation | Vet Pre-Trtmt Difficulties in Emotion Regulation | 106.6 units on a scale | Standard Deviation 23.9 |
| Structured Approach Therapy | Emotion Regulation | Vet Post-Trtmt Difficulties in Emotion Regulation | 88.7 units on a scale | Standard Deviation 24.4 |
| Structured Approach Therapy | Emotion Regulation | VetFollowup Difficulty in Emotion Regulation Scale | 87.29 units on a scale | Standard Deviation 26.84 |
| PTSD Family Education | Emotion Regulation | Vet Pre-Trtmt Difficulties in Emotion Regulation | 106.4 units on a scale | Standard Deviation 22.4 |
| PTSD Family Education | Emotion Regulation | Vet Post-Trtmt Difficulties in Emotion Regulation | 106.4 units on a scale | Standard Deviation 22.4 |
| PTSD Family Education | Emotion Regulation | VetFollowup Difficulty in Emotion Regulation Scale | 105.75 units on a scale | Standard Deviation 25.99 |
Comparison: General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.p-value: <0.0001Mixed Models Analysis
Secondary
Relationship Functioning
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Structured Approach Therapy | Relationship Functioning | Vet Pre-Trtmt Dyadic Adjustment Scale | 93.34 units on a scale | Standard Deviation 3.53 |
| Structured Approach Therapy | Relationship Functioning | Vet Post-Trtmt Dyadic Adjustment Scale | 105.18 units on a scale | Standard Deviation 3.84 |
| Structured Approach Therapy | Relationship Functioning | Vet Followup Dyadic Adjustment Scale | 106.76 units on a scale | Standard Deviation 3.84 |
| PTSD Family Education | Relationship Functioning | Vet Pre-Trtmt Dyadic Adjustment Scale | 101.82 units on a scale | Standard Deviation 3.6 |
| PTSD Family Education | Relationship Functioning | Vet Post-Trtmt Dyadic Adjustment Scale | 101.77 units on a scale | Standard Deviation 3.87 |
| PTSD Family Education | Relationship Functioning | Vet Followup Dyadic Adjustment Scale | 101.95 units on a scale | Standard Deviation 3.91 |
Comparison: Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.p-value: <0.001Mixed Models Analysis