Acceptance and Commitment Therapy for PTSD

(ACT-SS Trial)

Recruiting at 2 trial locations

Overseen By Megan M Kelly, PhD MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Substance use, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Megan Marie Kelly, PhD MS

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for Veterans aged 18+ with PTSD who struggle in social relationships. They must have a stable medication regimen for at least 2 months, be willing to be recorded, and score at least 31 on the PCL-5 scale. It's not open to those with recent suicidality, cognitive impairments, severe domestic violence issues, ongoing PTSD therapy or manic episodes, substance abuse within the last month, or any psychotic disorders.

Inclusion Criteria

You need to have a score of at least 31 on a specific questionnaire called the PCL-5.

You have significant problems getting along with other people.

I am able to understand and sign the consent form.

Exclusion Criteria

You have or had a serious mental illness called psychotic disorder.

I am currently experiencing a manic episode.

My thinking or memory problems do not prevent me from participating in studies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acceptance and Commitment Therapy to Improve Social Support (ACT-SS) or Present-Centered Therapy (PCT) for 12 weeks

12 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in social functioning, PTSD symptoms, and quality of life

6 months

3-month and 6-month follow-up assessments

Treatment Details

Interventions

• Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD
• Present-Centered Therapy

Trial Overview The study compares Acceptance and Commitment Therapy (ACT-SS), aimed at improving social support among veterans with PTSD by addressing interpersonal difficulties and avoidance behaviors against Present-Centered Therapy (PCT). The trial involves randomly assigning participants into two groups of 75 each to test which therapy is more effective.

Participant Groups

Group I: Acceptance and Commitment Therapy to Improve Social Support Experimental Treatment 1 Intervention

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 II: Present-Centered Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+