Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis.
Karen Cusack, Daniel E Jonas, Catherine A Forneris...
https://pubmed.ncbi.nlm.nih.gov/26574151Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06990191
A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Led by United States Department of Defense · Updated on 2025-11-14
420
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
United States Department of Defense
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
Post-Traumatic Stress Disorder (PTSD) affects up to 17% of post-9/11 US Service Members and is linked to long-term challenges such as family problems, unemployment, and risk of suicide. Trauma-focused therapies like Prolonged Exposure (PE) help many but are not effective for everyone, with about 40% retaining their PTSD diagnosis after treatment. This research aims to test whether adding a partner-assisted approach, called Partnered Prolonged Exposure (PPE), can improve psychosocial functioning and treatment outcomes compared to standard PE in Veterans. The study compares standard PE, which involves weekly 90-minute therapy sessions with the Veteran and therapist, to PPE, which adapts PE by incorporating strategies from Integrative Behavioral Couples Therapy. PPE includes twice-weekly 60-minute sessions, some with the Veteran and their intimate partner together and some with the Veteran alone. The partner acts as a coach and helps with trauma-related discussions, aiming to enhance treatment effects. The trial is a randomized controlled study involving 210 Veterans and their partners. Participants and their partners will undergo assessments at the start, mid-treatment, end of treatment, and at 3- and 6-month follow-ups. These evaluations include measures of psychosocial functioning, PTSD symptoms, depression, relationship functioning, caregiver burden, and distress. Researchers will also conduct interviews to understand factors influencing treatment and explore differences based on military sexual trauma history. The total study duration spans several months of treatment and follow-up to monitor outcomes and implementation strategies.
CONDITIONS
Brief Title
A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Post-9/11 Veteran enrolled in Veterans Health Administration (VHA)
- Stable medication for more than 1 month
- In a committed relationship lasting 6 months or longer
- Diagnosed with PTSD according to DSM-5 criteria
You will not qualify if you...
- Imminent risk of suicide or homicide
- Mania, psychosis, or severe substance use disorder within the past 3 months
- Severe cognitive impairment
- Severe intimate partner violence in the last 6 months
- Fear of or intimidation by partner
- Partner screens positive for PTSD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Duration varies by treatment protocol, typically several weeks of active therapy
Participants receive weekly or twice-weekly therapy sessions depending on their assigned treatment group. Sessions may involve the Veteran alone or with their partner to support PTSD treatment.
Weekly visits or twice-weekly visits depending on treatment group
Follow-up
Duration - Up to 6 months after treatment ends
Participants are assessed at multiple time points after treatment completion to monitor psychosocial functioning, PTSD symptoms, and related outcomes.
3 visits at 3 months and 6 months posttreatment
Trial Site Locations
Total: 4 locations
1
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012
Not Yet Recruiting
2
San Diego VA Healthcare System
San Diego, California, United States, 92161
Actively Recruiting
3
Minneapolis VA Healthcare System
Minneapolis, Minnesota, United States, 55417
Not Yet Recruiting
4
Charleston VA Healthcare System
Charleston, South Carolina, United States, 29401
Not Yet Recruiting
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Research Team
E
Emily M Hudson, PhD
D
Donald Lemon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials.
Maria M Steenkamp, Brett T Litz, Charles W Hoge...
https://pubmed.ncbi.nlm.nih.gov/26241600A multidimensional meta-analysis of psychotherapy for PTSD.
Rebekah Bradley, Jamelle Greene, Eric Russ...
https://pubmed.ncbi.nlm.nih.gov/15677582Posttraumatic stress disorder and intimate relationship problems: a meta-analysis.
Casey T Taft, Laura E Watkins, Jane Stafford...
https://pubmed.ncbi.nlm.nih.gov/21261431Posttraumatic stress disorder as a risk factor for suicidal ideation in Iraq and Afghanistan War veterans.
Matthew Jakupcak, Jessica Cook, Zac Imel...
https://pubmed.ncbi.nlm.nih.gov/19626682Posttraumatic stress disorder: the burden to the individual and to society.
R C Kessler
https://pubmed.ncbi.nlm.nih.gov/10761674Prevalence estimates of combat-related post-traumatic stress disorder: critical review.
Lisa K Richardson, B Christopher Frueh, Ronald Acierno
https://pubmed.ncbi.nlm.nih.gov/20073563