Post-Traumatic Stress DisorderPTSDNCT03191760
Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
A study testing Behavioral Activation in people with Post-Traumatic Stress Disorder, run by VA Puget Sound Health Care System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98116
About this study
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Behavioral Activation
- Keywords
- Posttraumatic Stress Disorder, Social Support, Primary Care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation and Social Engagement | Experimental | Participants will attend 6 in-person or phone-mediated 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. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist-Military Version
Change in PTSD symptoms
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Medical Outcomes Study Social Support Survey Form and Social Connectedness Scale - Revised
Change in social support
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Patient Health Questionnaire-9
Change in Depression symptoms
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Network Orientation Scale
Change in social network orientation
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Behavioral Activation for Depression Scale
Change in activity level
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Secondary outcomes (4)
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
Measured: 12 weeks
Additional treatment engagement
measured via medical record review
Measured: 16 weeks
Brief COPE
Change in coping strategies
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
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
Measured: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start8 Jun 2017
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Tracy Simpson, VA Puget Sound Health Care System
- Investigators
- Tracy Simpson, PhD, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191760
- Sponsor's protocol ID
- 00975
- Acronym
- PTSD
- Status last verified
- Nov 2023
- First submitted
- 9 Jun 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial of Behavioral Activation and Social Engagement (BASE) for Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT03191760
- Acronym / sponsor ID
- PTSD / 00975
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Social Support, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation and Social Engagement | Experimental | Behavioral: Behavioral ActivationParticipants will attend 6 in-person or phone-mediated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans who:
Key exclusion criteria (13 listed)
- Veterans who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationParticipants 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. | Behavioural | Behavioral Activation and Social Engagement |
Primary outcome
PTSD Checklist-Military Version
Time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Change in PTSD symptoms
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
Patient Health Questionnaire-9
Time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Change in Depression symptoms
Network Orientation Scale
Time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Change in social network orientation
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
4 secondary outcomes
Qualitative assessment
Time frame: 12 weeks
Additional treatment engagement
Time frame: 16 weeks
Brief COPE
Time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Social Connectedness Scale - Revised (SCS-R)
Time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Simpson, PhD principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Post-Traumatic Stress Disorder, run by VA Puget Sound Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-Military Version (time frame: baseline to 4 weeks, 4 weeks to 8 weeks, 8 weeks to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.