Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD

Study Overview
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Brief Summary
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Investigators will recruit up to 20 veterans with PTSD. Participants will be randomized into two conditions: MBSR and Health and Wellness Education (HWE; control group). Participants will be randomized at a 1:1 ratio. Purpose of the study is to learn how mindfulness meditation may be helpful in treating PTSD. Participants will undergo 2 screening sessions, 8 weekly sessions of intervention (MBSR or HWE), 3 laboratory visits that will include completing survey questionnaires, stress test and recording of heart rate, blood pressure and breathing rate.

Official Title
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Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD

Conditions
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Ptsd

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction (MBSR)
* Behavioral: Health and Wellness Education (HWE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (18-75yo) Military veteran Established PTSD diagnosis Reading and speaking in English Be able to travel to OHSU for three two-hour lab visits, 8 weekly intervention sessions and one long extended session, and a two- hour focus group Exclusion Criteria: Pregnancy Completed MBSR in past year; current regular personal mindfulness practice Completed trauma processing treatment (e.g., CPT or PE) Severe untreated depression, cognitive impairment, or active suicidality* Life-threatening or severely disabling medical conditions Excessive use of alcohol, nicotine, or cannabis Prescription medication that may influence physiological stress reactivity (e.g., beta blockers)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br> | Behavioral: Mindfulness-Based Stress Reduction (MBSR)<br>* MBSR consists of weekly two-hour sessions for eight weeks, and a 7.5 hour retreat between weeks 6 and 7. The MBSR intervention will be facilitated by an experienced and certified MBSR teacher. MBSR curriculum strongly encourages completion of home practice assignments ( 30 minutes daily) to help integration of concepts into daily life. Participants will receive audio CDs and a DVD to help guide home practice.<br>|
| Placebo Comparator: Health and Wellness Education<br> | Behavioral: Health and Wellness Education (HWE)<br>* HWE is a didactic-based group intervention designed as an active comparator for randomized-controlled trials of MBSR. HWE provides instruction to participants regarding improving their emotional and physical health. In contrast to MBSR, there are no attempts to train participants' breathing, movement, or meditation habits or practices. HWE is administered in 8 weekly 2.5-hour classes with home practice to be completed between sessions (matched to MBSR for amount and effort). HWE also features one extended 7.5-hour retreat, similar to MBSR.84 Dr. Autumn Gallegos (consultant) has conducted trials of MBSR among veterans with PTSD using a HWE control group, and will provide mentorship to the PI in administering the HWE intervention. Dr. Kaplan and a trained RA will facilitate HWE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interview targeting feasibility of MBSR | Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence. | 2 weeks post conclusion of intervention | 
| Qualitative interview targeting acceptability of MBSR | Qualitative data generated via focus group interviews. Questions will include ratings of the relevance of the content presented to participants' lives, as well as assessment of the method of presentation. | 2 weeks post conclusion of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological resilience 1 | Measured by self-report measure: Brief Resilience Scale (BRS). Scale ranges from 1-5 and higher scores indicate higher psychological resilience. | Pre (week 0), mid (week 4), and post intervention (week 10). | 
| Blood pressure reactivity | Reactivity of physiological parameters (e.g., systolic and diastolic blood pressure) to a cognitive stress task. | Pre (week 0), mid (week 4), and post intervention (week 10). | 
| PTSD symptoms 1 | Measured by a self-report questionnaire: the PTSD Symptom Checklist (PCL). Scores range from 0-4 and higher scores indicate more severe PTSD symptoms. | Pre (week 0), mid (week 4), and post intervention (week 10). | 
| Psychological resilience 2 | Measured by self-report measure: Connor-Davidson Resilience Scale (CD-RISC). Scores range from 0-4 and higher scores indicate higher psychological resilience. | Pre (week 0), mid (week 4), and post intervention (week 10). | 
| PTSD symptoms | Measured a clinician-administered semi-structured interview: the Clinician-Administered PTSD Scale (CAPS-5) | Pre (week 0), mid (week 4), and post intervention (week 10). |