Posttraumatic Stress Disorder Clinical Trial
— PTSDOfficial title:
Couple's Retreats for PTSD: Healing the Impacts of Trauma in Texas Veteran Families
Verified date | July 2023 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. The treatment is delivered over two days using an intensive, outpatient group (between 2 to 6 couples) format. Previous research has found that AIM-CBCT for PTSD decrease PTSD symptoms and improves relationship functioning in military veterans and service members with combat-related PTSD. The present study examines whether these original findings can be replicated in a broader military/Veteran sample of up to 80 couples. The investigators predict that AIM-CBCT for PTSD will be associated with significant decreases in PTSD symptoms, depression, and anxiety in Veteran/military service members, significant decreases in mental health symptoms in their romantic partners, and an increase in couple's satisfaction for both the Veteran/service members and their partners. Couples who agree to participate in the research study will be asked to participate in a 60-mintute pre-retreat meeting, the two-day retreat in which AIM-CBCT for PTSD will be delivered, and a 60-minute post-retreat check-in meeting. Additionally, each member of the couple will be asked to complete measures on their trauma history, mental health symptoms, and relationship functioning at baseline and at two and four weeks after the retreat.
Status | Terminated |
Enrollment | 20 |
Est. completion date | June 27, 2023 |
Est. primary completion date | June 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Cohabitating couples (ages 18 to 65 years old), who have been together for at least 4 months who reside in Texas. 2. At least one partner in the relationship is a Texas Veteran with significant PTSD symptoms as determined by the endorsement of at least one Criterion A event on the Life Event Checklist, the endorsement of at least one re-experiencing on the PCL-5 (i.e., a score of 2 or higher on Items 1, 2, 3, 4, or 5), the endorsement of at least one avoidance symptom on the PCL-5 (i.e., a score of 2 or higher on Items 6 or 7), and a total symptom score of 31 or higher on the PCL-5. 3. Both individuals must be willing to participate in the study. 4. Both individuals must be able to speak and read English. Exclusion Criteria: 1. Couple is separated and/or is taking steps to dissolve their relationship (e.g., divorce). 2. Veteran or partner are currently participating in an evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD). 3. Veteran or partner exhibit current psychiatric symptoms warranting immediate intervention that is beyond the scope of the treatment provided in this study. 4. Veteran or partner exhibit evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires) 5. Veteran or partner report current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS) 6. Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by Veteran or partner occurring within the past 6-months. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
United States,
Fredman SJ, Le Y, Macdonald A, Monson CM, Rhoades GK, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Jenkins AIC, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. A Closer Examination of Relational Outcomes from a Pilot Study of Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD with Military Dyads. Fam Process. 2021 Sep;60(3):712-726. doi: 10.1111/famp.12654. Epub 2021 Apr 20. — View Citation
Fredman SJ, Macdonald A, Monson CM, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Hancock AK, Rhoades GK, Yarvis JS, Resick PA, Roache JD, Le Y, Wachen JS, Niles BL, McGeary CA, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Intensive, Multi-Couple Group Therapy for PTSD: A Nonrandomized Pilot Study With Military and Veteran Dyads. Behav Ther. 2020 Sep;51(5):700-714. doi: 10.1016/j.beth.2019.10.003. Epub 2019 Nov 27. — View Citation
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Macdonald A, Fredman SJ, Taylor DJ, Pruiksma KE, Blount TH, Hall-Clark BN, Fina BA, Dondanville KA, Mintz J, Litz BT, Young-McCaughan S, Le Y, Jenkins AIC, Monson CM, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Secondary individual outcomes following multicouple group therapy for posttraumatic stress disorder: An uncontrolled pilot study with military dyads. J Trauma Stress. 2022 Feb;35(1):321-329. doi: 10.1002/jts.22729. Epub 2021 Nov 20. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD Checklist - DSM-5 (PCL-5) | Change in scale measurements by the PTSD CheckList-5. The PCL-5 is a 20-item, self-report measure of PTSD symptoms experienced in the past month. Each item is rated on a severity scale ranging from 0 (Not at all) to 4 (Extremely). The measure provides a total severity score that ranges from 0 to 80, with higher scores representing more PTSD symptoms. | Baseline, two-week post-retreat assessment, one-month post-retreat assessment | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | Change in scale measurements by the Patient Health Questionnaire-9. The PHQ-9 is 9-item, self-report screener for current depressive symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 27, with higher scores representing more severe depressive symptoms. | Baseline, two-week post-retreat assessment, one-month post-retreat assessment | |
Secondary | General Anxiety Disorder - 7 (GAD-7) | Change in scale measurements by the Generalized Anxiety Disorder Screener: The GAD-7 is 7-item, self-report screener for current anxiety symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 21, with higher scores representing more severe anxiety symptoms. | Baseline, two-week post-retreat assessment, one-month post-retreat assessment | |
Secondary | Couples Satisfaction Index-32 (CSI-32) | Change in scale measurements by the Couples' Satisfaction Index. The CSI-32 is 32-item, self-report measure of couple's satisfaction. Each item is rated on a 0 to 5 scale for a total score range of 0 to 161. Higher scores represent greater levels of relationship satisfaction with scores below 96 generally considered to reflect significant distress within the relationship. | Baseline, two-week post-retreat assessment, one-month post-retreat assessment |
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