Acceptance and Commitment Therapy to Improve Social Support for Veterans With PTSD

NCT ID: NCT04567680

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-02-11

Brief Summary

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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

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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.

Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
An independent evaluator will assess outcomes for each study participant.

Study Groups

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Acceptance and Commitment Therapy to Improve Social Support

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.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD

Intervention Type BEHAVIORAL

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.

Present-Centered Therapy

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.

Group Type ACTIVE_COMPARATOR

Present-Centered Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD

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.

Intervention Type BEHAVIORAL

Present-Centered Therapy

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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ACT-SS PCT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan Marie Kelly, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Bedford HealthCare System, Bedford, MA

Locations

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Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Site Status

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1I01RX003382-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D3382-R

Identifier Type: -

Identifier Source: org_study_id

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