Clinical trial NCT03191760: Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Official title: Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Social Support
Primary Care
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2017-06-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: PTSD Checklist-Military Version
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
measure: Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
measure: Patient Health Questionnaire-9
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
measure: Network Orientation Scale
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
measure: Behavioral Activation for Depression Scale
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Secondary outcomes:
measure: Qualitative assessment
timeFrame: 12 weeks
measure: Additional treatment engagement
timeFrame: 16 weeks
measure: Brief COPE
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
measure: Social Connectedness Scale - Revised (SCS-R)
timeFrame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: Research Scientist
name: Tracy Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: