Feasibility and Acceptability of Stress Induction, Physiological Data Collection, and Mindfulness-Based Stress Reduction Among Combat Veterans With PTSD
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Qualitative Interview Targeting Feasibility of MBSR
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (18-85yo)
- •Military veteran
- •Experiencing PTSD symptoms
- •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
- •Severe untreated depression, cognitive impairment, or active suicidality\*
- •Life-threatening or severely disabling medical conditions
- •Excessive use of alcohol, nicotine, or cannabis
Outcomes
Primary Outcomes
Qualitative Interview Targeting Feasibility of MBSR
Time Frame: 2 weeks post conclusion of intervention
Qualitative data generated via focus group interviews. Questions will include common barriers to completing the intervention and strategies utilized by participants to maximize adherence.
Qualitative Interview Targeting Acceptability of MBSR
Time Frame: 2 weeks post conclusion of intervention. Data were not collected due to prematurely study closure due to PI change of career.
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.
Secondary Outcomes
- Psychological Resilience 1(Pre (week 0), mid (week 4), and post intervention (week 10). Data were not collected due to prematurely study closure due to PI change of career.)
- Blood Pressure Reactivity(Pre (week 0), mid (week 4), and post intervention (week 10).)
- PTSD Symptoms 1(Pre (week 0), mid (week 4), and post intervention (week 10).)
- Psychological Resilience 2(Pre (week 0), mid (week 4), and post intervention (week 10).)
- PTSD Symptoms(Pre (week 0), mid (week 4), and post intervention (week 10).)
Investigators
Joshua Kaplan
Principal Investigator
Oregon Health and Science University