PTSD Clinical Trial - Intensive Weekend Retreat Multi-Couple Group Therapy

Status Completed

Clinical Trial Summary

The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed immediately before treatment, 1 month after treatment, and 3 months after treatment.

Clinical Trial Description

Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in both Service Members and Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. In prior work, the investigators have demonstrated that cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD), a 15-session couple-based therapy for PTSD, is efficacious in simultaneously treating PTSD and comorbid symptoms and improving intimate relationship functioning. However, the current format of fifteen 75-minute sessions over 15 weeks presents challenges for large-scale dissemination for active duty Service Members and recently discharged Veterans who have deployed in support of 9/11.

The purpose of this uncontrolled trial is to pilot a brief, scalable version of CBCT for PTSD in which session content is taught in an accelerated, multi-couple group format (AM-CBCT for PTSD) that has the potential for rapid dissemination and implementation, while capturing the majority of the benefits of the original therapy format. Accelerated, multi-couple group CBCT for PTSD (AM-CBCT for PTSD) will be delivered in a single weekend retreat to 24 active duty Service Members and recently discharged Veterans with PTSD who have deployed post-9/11 and their partners. Participants will be assessed at pre-treatment, one month after treatment, and 3 months after treatment.

The study seeks to answer the following questions:

1. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in clinician-rated PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), one month after treatment and at 3-month follow-up?

2. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in secondary outcomes (e.g., patient self-reported PTSD and comorbid symptom severity, relationship satisfaction), one month after treatment and at 3-month follow-up? ;

Study Design

Related Conditions & MeSH terms

PTSD

Clinical Trial Details

NCT number	NCT03158558
Study type	Interventional
Source	Penn State University
Contact
Status	Completed
Phase	N/A
Start date	September 2016
Completion date	February 2018

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03962504` - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial	N/A
Completed	`NCT01995123` - Behavioral Activation for Smoking Cessation in PTSD	N/A
Not yet recruiting	`NCT06278922` - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma	N/A
Completed	`NCT04597450` - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT03593772` - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD	N/A
Completed	`NCT03429166` - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas	N/A
Recruiting	`NCT04317820` - Deep Brain Reorienting in Post-traumatic Stress Disorder	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT03504722` - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD	N/A
Completed	`NCT04305353` - Intensive Care Unit (ICU) Diary Project	N/A
Completed	`NCT03113890` - McLean and Genomind Prospective Study	N/A
Withdrawn	`NCT05173831` - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans	Phase 2
Withdrawn	`NCT03924297` - Chilipad for Sleep and Symptoms of PTSD	N/A
Not yet recruiting	`NCT04056767` - Changes in Digital Phenotype During PE Therapy
Withdrawn	`NCT03216356` - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD	Phase 2/Phase 3
Completed	`NCT03343028` - Biomarker Establishment for Superior Treatment of PTSD
Completed	`NCT02370173` - A Non-Pharmacological Method for Enhancing Sleep in PTSD	N/A
Completed	`NCT01955538` - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.	Phase 3
Completed	`NCT01911585` - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure	N/A
Withdrawn	`NCT01957371` - Mindful Yoga Therapy for Veterans With PTSD and Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms