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

Not Applicable

Terminated

Conditions: Ptsd

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

Registration Number: NCT05938816

Lead Sponsor: Oregon Health and Science University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction	Mindfulness-Based Stress Reduction (MBSR)	-
Health and Wellness Education	Health and Wellness Education (HWE)	-

Primary Outcome Measures

Name	Time	Method
Qualitative Interview Targeting Feasibility of MBSR	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	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 Outcome Measures

Name	Time	Method
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.	Measured by self-report measure: Brief Resilience Scale (BRS). Scale ranges from 1-5 and higher scores indicate higher psychological resilience.
Blood Pressure Reactivity	Pre (week 0), mid (week 4), and post intervention (week 10).	Reactivity of physiological parameters (e.g., systolic and diastolic blood pressure) to a cognitive stress task.
PTSD Symptoms 1	Pre (week 0), mid (week 4), and post intervention (week 10).	Measured by a self-report questionnaire: the PTSD Symptom Checklist (PCL). Scores range from 0-4 and higher scores indicate more severe PTSD symptoms.
Psychological Resilience 2	Pre (week 0), mid (week 4), and post intervention (week 10).	Measured by self-report measure: Connor-Davidson Resilience Scale (CD-RISC). Scores range from 0-4 and higher scores indicate higher psychological resilience.
PTSD Symptoms	Pre (week 0), mid (week 4), and post intervention (week 10).	Measured a clinician-administered semi-structured interview: the Clinician-Administered PTSD Scale (CAPS-5). Symptoms are rated for severity (0-absent; 1-mild/subthreshold; 2-moderate/threshold; 3-severe/markedly elevated; 4-extreme/incapacitating) and the presence of distress (minimal; clearly present; pronounced; extreme). Symptom clusters are also rated for the likelihood that they are related to the index trauma (definite; probable; unlikely).