Clinical trial NCT05274061: Couple's Retreats for Posttraumatic Stress Disorder
Official title: Couple's Retreats for PTSD: Healing the Impacts of Trauma in Texas Veteran Families
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic stress disorder
Conjoint Therapy
Cognitive Behavioral Treatment
Intensive Treatments
Couples
Cognitive Behavioral Conjoint Therapy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single group treatment study in which every couple will receive the intervention (AIM-CBCT).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. Prior studies support the use of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) to treat PTSD and comorbid symptoms while simultaneously improving intimate relationship functioning. However, the standard outpatient format of CBCT for PTSD (i.e., fifteen 75-minute sessions over 15 weeks) presents challenges for many couples as well as for large-scale dissemination. To address these concerns, Dr. Steffany Fredman in collaboration with the STRONG STAR Consortium to Alleviate PTSD adapted CBCT for PTSD into an accelerated, intensive, multiple-couple format (AIM-CBCT for PTSD). The initial data of AIM-CBCT for PTSD tested in 24 couples was promising suggesting that this two-day retreat can reduce PTSD symptoms and improve mental health and relationship functioning in post-9/11 service members/veteran couples.

In September 2021, the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) initiated a clinical program which provides AIM-CBCT for PTSD to Texas Veteran couples impacted by PTSD symptoms. Within the clinical program, couples are asked to participate in an intake assessment to determine eligibility for treatment, a 60-minute pre-retreat meeting, a two-day retreat, a two-week post-retreat assessment, and a two-week post-retreat check-in. Couples who are eligible for the clinical program will be invited to participate in this replication study, which examines whether AIM-CBCT for PTSD is associated with reductions in PTSD and improvements in relationship functioning in a broader Veteran sample of up to 80 couples.

Research Questions and Hypotheses:

1. Will Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy delivered in a 2-day retreat (AIM-CBCT for PTSD) be associated with significant improvements in patient-rated PTSD symptom severity, as measured by the PTSD Checklist-DSM-5 (PCL-5), when assessed two-weeks and one month after treatment?

   Hypothesis 1: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of self-reported PTSD symptoms on the Posttraumatic Checklist-DSM 5 (PCL-5) at the one-month follow-up assessment.
2. Will AIM-CBCT for PTSD be associated with significant improvements in secondary outcomes (e.g., patient self-reported comorbid symptom severity, relationship satisfaction) when assessed two-weeks and one month after treatment?

Hypothesis 2: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of Veteran/Service members' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.

Hypothesis 3: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of partners'' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.

Hypothesis 4: Participation in AIM-CBCT for PTSD will be associated with a significant increase in self-reported relationship satisfaction on the Couples Satisfaction Index-32) at the one-month follow-up assessment for both partners.

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD Checklist - DSM-5 (PCL-5)
timeFrame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
measure: General Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
measure: Couples Satisfaction Index-32 (CSI-32)
timeFrame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: UT Health Science Center San Antonio
name: Alan L Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
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citation: Monson CM, Fredman SJ. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. New York: Guilford. 2012
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citation: Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.