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

NCT03191760 | Completed

• 1 other identifier: 00975
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Social Support; Primary Care

Outcome Measures

Primary Outcomes (5)

• PTSD Checklist-Military Version

  Change in PTSD symptoms

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

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

  Change in social support

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

• Patient Health Questionnaire-9

  Change in Depression symptoms

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

• Network Orientation Scale

  Change in social network orientation

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

• Behavioral Activation for Depression Scale

  Change in activity level

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Secondary Outcomes (4)

• Qualitative assessment

  12 weeks

• Additional treatment engagement

  16 weeks

• Brief COPE

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

• Social Connectedness Scale - Revised (SCS-R)

  baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Study Arms (1)

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.

Behavioral: Behavioral Activation

Interventions

Behavioral Activation BEHAVIORAL

Participants will be asked to attend 6 in-person or phone-mediated therapy sessions lasting approximately 45 minutes per session, to be 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.

Behavioral Activation and Social Engagement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98116, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Tracy Simpson, PhD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 19, 2017
• Study Start: June 8, 2017
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)