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Acceptance and Commitment Therapy for PTSD (ACT-SS Trial)

N/A

Waitlist Available

Led By Megan Marie Kelly, PhD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Competent to provide written informed consent

Current DSM-5 PTSD diagnosis

Must not have

Current manic episode

Cognitive impairment that would interfere with study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a treatment focused on helping veterans with PTSD to increase social support will be more effective than a common treatment for social support difficulties.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for therapies like ACT-SS and PCT as they are psychological treatments rather than drugs; participants may experience emotional discomfort discussing traumatic events or changing long-standing behavior patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and sign the consent form.

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I have been diagnosed with PTSD.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing a manic episode.

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

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I am currently undergoing therapy for PTSD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the MOS Social Support Survey

Change in the Social Adjustment Scale-Self Report

Secondary study objectives

Change in the Clinician Administered PTSD Scale (CAPS-5)

Change in the PTSD Checklist (PCL-5)

Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance and Commitment Therapy to Improve Social SupportExperimental Treatment1 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 TherapyActive Control1 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.

0 / 6Eligibility criteria met