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

Post-Traumatic Stress Disorder Clinical Trial

— PTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191760
• Other study ID #: 00975
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: February 18, 2020

Study information

• Verified date: November 2023
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist-Military Version	Change in PTSD symptoms	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Primary	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
Primary	Patient Health Questionnaire-9	Change in Depression symptoms	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Primary	Network Orientation Scale	Change in social network orientation	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Primary	Behavioral Activation for Depression Scale	Change in activity level	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Secondary	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
Secondary	Additional treatment engagement	measured via medical record review	16 weeks
Secondary	Brief COPE	Change in coping strategies	baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Secondary	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