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

NCT05938816 | Terminated Results

• 2 other identifiers: STUDY00025508KL2TR002370
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Ptsd

Outcome Measures

Primary Outcomes (2)

• 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. Data were not collected due to prematurely study closure due to PI change of career.

Secondary Outcomes (5)

• 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).

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Health and Wellness Education

PLACEBO COMPARATOR

Behavioral: Health and Wellness Education (HWE)

Interventions

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

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.

Mindfulness-Based Stress Reduction

Health and Wellness Education (HWE) BEHAVIORAL

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.

Health and Wellness Education

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Severe untreated depression, cognitive impairment, or active suicidality\*
• Life-threatening or severely disabling medical conditions
• Excessive use of alcohol, nicotine, or cannabis

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Oregon Clinical and Translational Research Institute: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Stress Reduction; Health

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Results Point of Contact

• Title: Josh Kaplan, PhD
• Organization: Oregon Health and Science University

kaplajos@ohsu.edu

503) 494-8311

Study Officials

• Josh Kaplan, PhD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 10, 2023
• Study Start: July 7, 2023
• Primary Completion: November 28, 2023
• Study Completion: February 3, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)