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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05938816

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ptsd	Behavioral: Mindfulness-Based Stress Reduction (MBSR) Behavioral: Health and Wellness Education (HWE)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 7, 2023

Anticipated Primary Completion Date :

Jul 7, 2025

Anticipated Study Completion Date :

Jul 7, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]
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

Psychological resilience 1 [Pre (week 0), mid (week 4), and post intervention (week 10).]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT05938816

Other Study ID Numbers:

STUDY00025508

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 10, 2023