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

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Ptsd

Treatments: Behavioral: Health and Wellness Education (HWE); Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05938816

STUDY00025508

KL2TR002370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups, including a placebo group

Mindfulness-Based Stress Reduction

Experimental group

Treatment:

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Health and Wellness Education

Placebo Comparator group

Treatment:

Behavioral: Health and Wellness Education (HWE)