Back to resultsOpen Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD) (PTSD)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Social Support, Primary Care
Eligibility Criteria
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
Sites / Locations
- VA Puget Sound Health Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral Activation and Social Engagement
Arm Description
Participants will attend 6 in-person 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.
Outcomes
Primary Outcome Measures
PTSD Checklist-Military Version
Change in PTSD symptoms
Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised
Change in social support
Patient Health Questionnaire-8
Change in Depression symptoms
Network Orientation Scale
Change in social network orientation
Behavioral Activation for Depression Scale
Change in activity level
Secondary Outcome Measures
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
Additional treatment engagement
measured via medical record review
Full Information
NCT ID
NCT03191760
First Posted
June 9, 2017
Last Updated
February 8, 2019
Sponsor
VA Puget Sound Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT03191760
Brief Title
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Acronym
PTSD
Official Title
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Social Support, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Activation and Social Engagement
Arm Type
Experimental
Arm Description
Participants will attend 6 in-person 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
Participants will be asked to attend 6 in-person 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 Outcome Measure Information:
Title
PTSD Checklist-Military Version
Description
Change in PTSD symptoms
Time Frame
baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Title
Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised
Description
Change in social support
Time Frame
baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Title
Patient Health Questionnaire-8
Description
Change in Depression symptoms
Time Frame
baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Title
Network Orientation Scale
Description
Change in social network orientation
Time Frame
baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Title
Behavioral Activation for Depression Scale
Description
Change in activity level
Time Frame
baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Secondary Outcome Measure Information:
Title
Qualitative assessment
Description
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
Time Frame
12 weeks
Title
Additional treatment engagement
Description
measured via medical record review
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Simpson, PhD
Organizational Affiliation
Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98116
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
We'll reach out to this number within 24 hrs