Primary Care Brief Mindfulness Training for Veterans With PTSD
Primary Purpose
Post-traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Brief Mindfulness Training
PTSD Psychoeducational Class
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- enrolled in services at the Syracuse or Canandaigua VAMC and
- report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).
Exclusion Criteria:
- gross cognitive impairment (>16 on the Blessed OMC),
- suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).
- have received psychotherapy or change in psychiatric medication outside of VHA primary care in the last 2 months.
- voice a preference to be directly referred to specialty mental health care.
Sites / Locations
- Syracuse Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Primary Care Brief Mindfulness Training
PTSD Psychoeducational Class
Arm Description
group-based mindfulness training
group-based psychoeducation class
Outcomes
Primary Outcome Measures
Number of Participants With Assessment Retention Assessment Retention
rate of participants who complete all assessment time points
Intervention Retention
rate of participants who complete assigned intervention
Primary Care Brief Mindfulness Fidelity Assessment
Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.
Client Satisfaction Scale
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
Secondary Outcome Measures
Post-traumatic Stress Checklist for DSM-5
PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.
Recovery Orientation Scale- 24
Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.
Patient Health Questionnaire-9,
Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.
Self Compassion Scale- Short Form
Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.
Health Promoting Lifestyle Profile II: Health Responsibility Subscale
Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.
Full Information
NCT ID
NCT03352011
First Posted
November 14, 2017
Last Updated
November 22, 2022
Sponsor
Syracuse VA Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT03352011
Brief Title
Primary Care Brief Mindfulness Training for Veterans With PTSD
Official Title
Primary Care Brief Mindfulness Training for Veterans With PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
June 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Syracuse VA Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The proposed study supports a line of research that seeks to improve the health of military veterans with post-traumatic stress disorder (PTSD) by teaching them mindfulness skills. The proposed study first gathers Veteran's Affairs mental health provider and peer support specialist feedback to adapt a brief mindfulness intervention and then investigates the feasibility of testing this intervention in a small randomized clinical trial. The study targets primary care patients with PTSD who may be reluctant to engage in other mental health treatments and provides them with mindfulness training to reduce PTSD symptoms, improve psychosocial functioning and increase hope for recovery.
Detailed Description
Posttraumatic Stress Disorder (PTSD) is highly prevalent in Veterans Affairs (VA) primary care patients (~11.5%) and is associated with significant functional impairment, compromised health, and economic costs. While effective psychotherapies for PTSD are available in VA specialty mental health care settings, primary care patients do not routinely engage in or complete these specialty services. Therefore, alternative delivery models are needed. This proposal integrates two lines of research: mindfulness training and peer support services to test a low-stigma intervention in primary care: Primary Care Based Mindfulness Training (PCBMT). Brief mindfulness training focuses on skill acquisition to help patients manage distress and can serve as a gateway to more intensive treatments for Veterans who are not yet willing to discuss their trauma histories. Peer support specialists help shift treatment away from the medical model focused on symptom reduction to a recovery model focused on leading a meaningful, purposeful life, with or without ongoing illness.
This proposal aims to refine our existing PCBMT to be co-delivered by VA mental health providers and peers and then test important aspects of feasibility to prepare for a future full-scale pragmatic clinical trial. First, VA providers and peers will participate in PCBMT led by study investigators who are certified Mindfulness Based Stress Reduction (MBSR) instructors. Next, study staff will gather feedback from the trained providers and peers for further adaptation and implementation. After this, providers and peers interested in being trained as PCBMT interventionists will be trained by study investigators. Finally, a pilot RCT will be conducted. Both treatments conditions will consist of four, 90-minute group sessions co-facilitated by a VA provider and Veteran peer.
The long-term goal of this research is to improve clinical and personal recovery outcomes for Veterans with PTSD. Our immediate goals are to refine PCBMT based on Veteran, provider, and peer feedback then test the methods needed to conduct a future full-scale RCT, in accordance with the following aims:
Gather VA mental health provider (n=5) and peer (n=5) feedback to refine PCBMT to a) ensure successful implementation in the VA setting (including creation of a provider manual and standardized provider/peer training curriculum) and b) maximize Veteran skill development to aid in future participation of evidence-based treatment for PTSD.
Assess the feasibility of conducting a pilot RCT (N=60) comparing PCBMT to a PTSD psychoeducation group on a) rates of recruitment and study retention, b) participant adherence and retention in treatment, provider and peer treatment fidelity, c) participant acceptability (satisfaction, perceived helpfulness) in PCBMT and control condition, and d) measuring outcomes of interest for the future larger trial including: PTSD severity, psychosocial functioning, recovery orientation, active engagement in mental health care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Care Brief Mindfulness Training
Arm Type
Experimental
Arm Description
group-based mindfulness training
Arm Title
PTSD Psychoeducational Class
Arm Type
Active Comparator
Arm Description
group-based psychoeducation class
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Brief Mindfulness Training
Intervention Description
Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.
Intervention Type
Behavioral
Intervention Name(s)
PTSD Psychoeducational Class
Intervention Description
The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include "Civilian Readjustment and PTSD," "Trust, Safety, and Healing" and "Treatment Strategies."
Primary Outcome Measure Information:
Title
Number of Participants With Assessment Retention Assessment Retention
Description
rate of participants who complete all assessment time points
Time Frame
enrollment to 24 week follow-up
Title
Intervention Retention
Description
rate of participants who complete assigned intervention
Time Frame
enrollment to 24 week follow-up
Title
Primary Care Brief Mindfulness Fidelity Assessment
Description
Number of essential components of the Primary Care Brief Mindfulness Training curriculum delivered across all 5 cohorts of PCBMT. Number of essential components 0-90. Higher scores indicate more components delivered and better fidelity.
Time Frame
enrollment to 8 week follow-up
Title
Client Satisfaction Scale
Description
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
Time Frame
8 week follow-up
Secondary Outcome Measure Information:
Title
Post-traumatic Stress Checklist for DSM-5
Description
PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.
Time Frame
24 week follow-up
Title
Recovery Orientation Scale- 24
Description
Recovery Orientation Scale-24 measuring recovery from mental health concerns. Range 24-120, with 120 indicating the greatest amount of recovery.
Time Frame
24 week follow-up
Title
Patient Health Questionnaire-9,
Description
Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.
Time Frame
24 week follow-up
Title
Self Compassion Scale- Short Form
Description
Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.
Time Frame
8 week post-treatment
Title
Health Promoting Lifestyle Profile II: Health Responsibility Subscale
Description
Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.
Time Frame
24 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
enrolled in services at the Syracuse or Canandaigua VAMC and
report significant PTSD symptoms (qualifying criterion A traumatic event plus at least a 31 on the PCL-5).
Exclusion Criteria:
gross cognitive impairment (>16 on the Blessed OMC),
suicide attempt or desire to commit suicide in the last month (as measured by P4 screener).
have received psychotherapy or change in psychiatric medication outside of VHA primary care in the last 2 months.
voice a preference to be directly referred to specialty mental health care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, Ph.D.
Organizational Affiliation
VA Center for Intergrated Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse Veterans Affairs Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Primary Care Brief Mindfulness Training for Veterans With PTSD
We'll reach out to this number within 24 hrs