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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Behavioral Activation

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98116
      • VA Puget Sound Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Veterans who:

  1. 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
  2. meet criteria for clinical or subclinical PTSD
  3. are willing to have therapy sessions audiotaped for the purposes of supervision
  4. plan to live in the Seattle area for 6 months following entry into the study

Exclusion Criteria:

• Veterans who:

  1. exhibit the presence of severe mental illness diagnosis (e.g., active psychosis and/or uncontrolled bipolar disorder)
  2. have been a psychiatric in-patient admission in the past 30 days
  3. have had a suicide attempt in the last 60 days
  4. have had a plan or intent to harm self or others in the last 30 days
  5. have a behavioral flag in their medical record
  6. have had a psychiatric medication dosing or receipt that has changed in the last 30 days
  7. are unwilling to provide at least 1 collateral contact
  8. 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
  9. are prisoners
  10. are illiterate or have limited or no English proficiency
  11. are terminally ill
  12. are currently participating in Cognitive Processing Therapy (CPT) or Prolonged Exposure Therapy (PE)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral Activation and Social Engagement; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient Health Questionnaire-9	Change in Depression symptoms	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment	Participants' reactions to the treatment will be gathered in qualitative interviews assessing treatment experience, perceptions of treatment focus, engagement with valued activities, social support, therapeutic relationship	12 weeks
Additional treatment engagement	measured via medical record review	16 weeks
Brief COPE	Change in coping strategies	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Social Connectedness Scale - Revised (SCS-R)	Change in the level of interpersonal closeness related to participants' social environment and the degree of difficulty experienced by participants in sustaining the sense of closeness	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks

Collaborators and Investigators

• Sponsor: VA Puget Sound Health Care System
• Investigators: Principal Investigator: Tracy Simpson, PhD, Research Scientist

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): February 18, 2020
• Study Completion (Actual): February 18, 2020

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Posttraumatic Stress Disorder; Social Support
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 00975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No