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Clinical Trials/NCT03191760
NCT03191760CompletedNot Applicable

Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)

VA Puget Sound Health Care System1 site in 1 country27 target enrollmentStarted: June 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
PTSD Checklist-Military Version

Study Overview

Brief Summary

The purpose of the study is to see if "Behavioral Activation and Social Engagement for PTSD" (BASE for PTSD), an individual therapy for PTSD, will help Veterans with PTSD 1) through improved understanding of how PTSD affects them, 2) by reducing ways in which they avoid meaningful activity due to PTSD, 3) by enabling them to do more of the things they really care about, and 4) by improving, strengthening, and building up their social supports.

Detailed Description

Posttraumatic stress disorder (PTSD) is a mental health condition that some people develop following exposure to a traumatic event. PTSD often results in a reduction in feelings of connection to other people and changes in views about others, as well as reduced participation in valued activities. Many veterans with PTSD do not seek treatment offered in specialty mental health settings and may forgo treatment of any kind.

This study is an open-trial format (no comparison condition) of U.S. military veterans who will participate in a brief psychotherapy treatment for PTSD offered in a Primary Care setting. This is a pilot trial to see if the treatment is effective at reducing symptoms of PTSD and increasing feelings of social support, and an exploratory aim is to see if veterans engage in additional treatment after completing this treatment.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Veterans who:
  • •are currently enrolled in either of the Primary Care Clinics (including Women's Clinic) or Primary Care Mental Health Integration clinic at VA Puget Sound Health Care System - Seattle Division
  • •meet criteria for clinical or subclinical PTSD
  • •are willing to have therapy sessions audiotaped for the purposes of supervision
  • •plan to live in the Seattle area for 6 months following entry into the study

Exclusion Criteria

  • •Veterans who:
  • •exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder)
  • •have been a psychiatric in-patient admission in the past 30 days
  • •have had a suicide attempt in the last 60 days
  • •have had a plan or intent to harm self or others in the last 30 days
  • •have a behavioral flag in their medical record
  • •have had a psychiatric medication dosing or receipt that has changed in the last 30 days
  • •are unwilling to provide at least 1 collateral contact
  • •have impaired decision making capacity (as measured by evidence in the Computerized Patient Record System record of moderate-severe Traumatic Brain Injury, uncontrolled psychosis, dementia, communication flag, or by clinical judgment in speaking with the participant
  • •are prisoners
  • •are illiterate or have limited or no English proficiency
  • •are terminally ill
  • •are currently participating in Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE)

Arms & Interventions

Behavioral Activation and Social Engagement

Experimental

Participants will attend 6 in-person or phone-mediated therapy sessions lasting approximately 45 minutes per session, held in Primary Care settings. Content of therapy sessions includes education about PTSD symptoms, discussion of the role of avoidance in maintaining PTSD symptoms, self-monitoring homework to identify links between activity level and emotions, and homework designed to increase engagement in valued activities, with a focus on increasing social contact and support. If relevant, participants will be instructed in basic communication skills, social skills, and relaxation skills. We have modified the standard Behavioral Activation intervention by reducing the number and length of sessions to accommodate the Primary Care setting. In addition, there will be a stronger emphasis on social engagement in BASE then in standard BA and social contact and support will be addressed during each treatment session.

Intervention: Behavioral Activation (Behavioral)

Outcomes

Primary Outcomes

PTSD Checklist-Military Version

Time Frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in PTSD symptoms

Network Orientation Scale

Time Frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in social network orientation

Patient Health Questionnaire-9

Time Frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in Depression symptoms

Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised

Time Frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in social support

Behavioral Activation for Depression Scale

Time Frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Change in activity level

Secondary Outcomes

  • Social Connectedness Scale - Revised (SCS-R)(baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks)
  • Brief COPE(baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks)
  • Qualitative assessment(12 weeks)
  • Additional treatment engagement(16 weeks)

Investigators

Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Tracy Simpson

Clinician Investigator

VA Puget Sound Health Care System

Study Sites (1)

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