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OpenTrials
Completed

NCT Number: NCT03191760

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

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98116, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. PTSD Checklist-Military Version

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

    Change in PTSD symptoms

  2. 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

  3. Patient Health Questionnaire-9

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

    Change in Depression symptoms

  4. Network Orientation Scale

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

    Change in social network orientation

  5. 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

  1. Qualitative assessment

    Time frame: 12 weeks

    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

  2. Additional treatment engagement

    Time frame: 16 weeks

    measured via medical record review

  3. Brief COPE

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

    Change in coping strategies

  4. Social Connectedness Scale - Revised (SCS-R)

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

    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

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Registry information

Acronym: PTSD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2017
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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