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

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 Overview

• Status: Enrolling by invitation
• Conditions: Ptsd
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MBSR); Behavioral: Health and Wellness Education (HWE)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Prescription medication that may influence physiological stress reactivity (e.g., beta blockers)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction	Behavioral: Mindfulness-Based Stress Reduction (MBSR); 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.
Placebo Comparator: Health and Wellness Education	Behavioral: Health and Wellness Education (HWE); 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.

What is the study measuring?

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). 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).	Pre (week 0), mid (week 4), and post intervention (week 10).

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): July 7, 2025
• Study Completion (Estimated): July 7, 2026

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00025508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No