Clinical trial NCT04567680: Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
Official title: Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: PTSD
Social Support
Veterans
Social Functioning
Community Reintegration
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-28
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Veterans with PTSD often have substantial interpersonal problems and low perceived social support from family, partners, and peers. Interpersonal problems result in poor social reintegration, which in turn permeates all aspects of their functioning and is associated with greater suicidal ideation. The problems emerge rapidly, with one study showing a fourfold increase in rates of self-reported interpersonal conflict within six months of returning from deployment. Veterans with PTSD report considerable avoidance in relationships, marital stress, intimacy difficulties, and parenting problems. Low social support is a key factor related to poor physical health, emotional functioning, and increased mortality risk. Given the importance of social relationships in buffering against negative outcomes and suicidal ideation for persons with PTSD, there is a strong need for more research and treatment development to improve the social functioning of these Veterans. The proposed project will focus on evaluating an innovative treatment for improving the social relationships and social support among Veterans with PTSD.

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. ACT-SS provides Veterans with PTSD with more adaptive coping skills (i.e., acceptance and mindfulness, focus on values-based living) to improve social relationships, social support, and help manage PTSD-related distress. The investigators' pilot data of ACT-SS indicates that ACT-SS results in improved social relationships and reduced PTSD symptoms, with preliminary data showing that ACT-SS results in significantly better improvement in social functioning outcomes compared to Present-Centered Therapy (PCT).

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. Study outcomes will include measures of social support, social relationships, quality of life, and PTSD symptoms. This proposal, supported by the promising pilot data, represents an important step in examining the potential efficacy of ACT-SS, including social functioning and quality of life in Veterans with PTSD. If positive, results from this study may provide a new treatment approach for improving the social reintegration of Veterans with PTSD.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Social Adjustment Scale-Self Report
timeFrame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
measure: Change in the MOS Social Support Survey
timeFrame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Secondary outcomes:
measure: Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
timeFrame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
measure: Change in the Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
measure: Change in the PTSD Checklist (PCL-5)
timeFrame: Baseline, End of Treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Megan Marie Kelly, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: