Syracuse Veterans Affairs Medical Center
Syracuse, New York, 13210, United States
NCT Number: NCT03352011
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Syracuse, New York, 13210, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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."
Time frame: enrollment to 24 week follow-up
rate of participants who complete all assessment time points
Time frame: enrollment to 24 week follow-up
rate of participants who complete assigned intervention
Time frame: enrollment to 8 week follow-up
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: 8 week follow-up
measured by the Client Satisfaction Questionnaire, scale range 1-32 with 32 indicating highest satisfaction.
Time frame: 24 week follow-up
PTSD Checklist-5. Scale range 0-63 with 63 indicating highest PTSD severity.
Time frame: 24 week follow-up
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
Patient Health Questionnaire-9, range 0-27, with 27 indicating the greatest amount of depression.
Time frame: 8 week post-treatment
Self Compassion Scale- Short Form, range 0-60, with 60 indicating the greatest amount of self compassion.
Time frame: 24 week follow-up
Health Promoting Lifestyle Profile II: Health Responsibility. Subscale ranges from 9-36, with 36 indicating the most health responsibility.
Syracuse VA Medical Center
Fed
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