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

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ClinicalTrials.gov Identifier: NCT03191760
Recruitment Status : Active, not recruiting
First Posted : June 19, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tracy Simpson, VA Puget Sound Health Care System

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Behavioral Activation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation and Social Engagement
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.
Behavioral: Behavioral Activation
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 Measures :
  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-8 [ 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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191760


Locations
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United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98116
Sponsors and Collaborators
VA Puget Sound Health Care System
Investigators
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Principal Investigator: Tracy Simpson, PhD Research Scientist

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Responsible Party: Tracy Simpson, Clinician Investigator, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT03191760     History of Changes
Other Study ID Numbers: 00975
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tracy Simpson, VA Puget Sound Health Care System:
Posttraumatic Stress Disorder
Social Support
Primary Care

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders