Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
ACT-SS
2 other identifiers
interventional
107
1 country
3
Brief Summary
Veterans with PTSD often have impaired social relationships and poor social support. The negative outcomes associated with poor social support are of particular concern for Veterans with PTSD, who often perceive the world to be dangerous, view their social support network as a threat to their safety, and avoid members of their support network in order to increase their perceived safety. The goal of this project is to evaluate the efficacy of Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD (ACT-SS), a treatment focused on helping Veterans with PTSD to increase social support with family relationships, partners, and peers by targeting maladaptive patterns of interpersonal difficulties, feelings of detachment from others, irritability, and avoidance of social situations. The primary aim of this study is to conduct a two-site randomized controlled trial of ACT-SS (n=75) vs. PCT (n=75), a common treatment for social support difficulties. If positive, this study will provide a critically-needed treatment for Veterans with PTSD to improve their social functioning and social reintegration in the community.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2025
CompletedResults Posted
Study results publicly available
February 13, 2026
CompletedFebruary 13, 2026
January 1, 2026
4 years
September 23, 2020
January 27, 2026
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in the Social Adjustment Scale-Self Report
The Social Adjustment Scale-Self Report (SAS-SR) is a 54-item measure of current social functioning in 6 domains: Work; Social and Leisure; Extended Family; Primary Relationship; Parental; and Family Unit. The Social and Leisure scale is the primary measure of change in social functioning for the study. Lower scores indicate better functioning. Scores on this scale range from 1-5.
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the MOS Social Support Survey
Social Support: The MOS Social Support Survey is a 19-item multidimensional, self-administered survey of social support for individuals with chronic conditions. It includes four functional support scales, including emotional/informational, tangible, affectionate, and positive social interaction. A higher score for an individual scale or for the overall support index indicates more support. Scores range from 1-5.
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Secondary Outcomes (3)
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the Clinician Administered PTSD Scale (CAPS-5)
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Change in the PTSD Checklist (PCL-5)
Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Study Arms (2)
Acceptance and Commitment Therapy to Improve Social Support
EXPERIMENTALThis treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
Present-Centered Therapy
ACTIVE COMPARATORPCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
Interventions
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
Eligibility Criteria
You may qualify if:
- Current DSM-5 PTSD diagnosis
- Minimum score of 31 on the PCL-5
- Clinically significant difficulties in interpersonal relationships
- Competent to provide written informed consent
- Ages 18 and older
- If being treated with psychoactive medication, no change in drugs or dose for the past 2 months
- Willingness to be audio-taped
You may not qualify if:
- Any current or lifetime DSM-5 psychotic disorder
- Current or recent (within 1 month of study entry) DSM-5 substance use disorder
- Cognitive impairment that would interfere with study participation
- Current manic episode
- Recent clinically significant suicidality (past 3 months)
- Moderate to severe domestic violence (measured by the Conflict Tactics Scale-2)
- Current PTSD psychotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Megan M. Kelly, Ph.D., Research Investigator, VA Bedford Healthcare System
- Organization
- VA Bedford Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Marie Kelly, PhD MS
VA Bedford HealthCare System, Bedford, MA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- An independent evaluator will assess outcomes for each study participant.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
September 28, 2020
Study Start
March 1, 2021
Primary Completion
February 11, 2025
Study Completion
February 11, 2025
Last Updated
February 13, 2026
Results First Posted
February 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be available after the project has ended and will be available for seven years after the project has closed.
Final data sets from the study, composed of de-identified data, will be archived and available to others by request to the PI. All publications from this study will be made available to the public through the National Library of Medicine PubMed Central website within one year after the research article is published.