NCT04793698

Brief Summary

Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

February 11, 2021

Last Update Submit

March 24, 2026

Conditions

Posttraumatic Stress Disorder

Keywords

MeditationCompassion meditationVeteransComplementary and alternative medicinePTSD

Outcome Measures

Primary Outcomes (7)

  • Enrolment rate

    Proportion of consented subjects among all screened and eligible patients.

    10 weeks

  • Initiation rate

    Proportion of subjects who initiate the intervention among all consented subjects.

    10 weeks

  • Per protocol completion rate

    Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.

    10 weeks

  • Intent-to-treat completion rate

    Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.

    10 weeks

  • Credibility

    An average of 3 items rated on a Likert scale.

    10 weeks

  • Practice time

    Number of minutes of practice divided the number of minutes assigned.

    10 weeks

  • Participant satisfaction score

    Client Satisfaction Questionnaire (CSQ-8) score, an 8-item measure of satisfaction with services received. A total score will be calculated for comparison with normative data and with previous groups.

    10 weeks

Secondary Outcomes (2)

  • Therapist fidelity to intervention

    10 weeks

  • Therapist adequacy addressing treatment elements

    10 weeks

Study Arms (2)

Compassion meditation

EXPERIMENTAL

Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.

Other: Compassion meditation

Applied relaxation

ACTIVE COMPARATOR

Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.

Behavioral: Applied relaxation

Interventions

Compassion meditationOTHER

10 week meditation course taught in 90-minute groups

Compassion meditation
Applied relaxationBEHAVIORAL

10 week applied relaxation course taught in 90-minute groups

Applied relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran status
  • Able/willing to consent
  • Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD with accompanying distress and impairment

You may not qualify if:

  • Serious suicidality or homicidality
  • Known, untreated substance use or dependence problem
  • Untreated/unstable serious mental illness
  • Cognitive impairment that would interfere with study activities
  • Concurrent enrollment in other treatment for PTSD or other meditation-based practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Bedford Healthcare System

Bedford, Massachusetts, 01730, United States

Location

VA Finger Lakes HCS

Canandaigua, New York, 14424-1159, United States

Location

Durham VA Health Care System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded to intervention arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

March 11, 2021

Study Start

May 6, 2021

Primary Completion

September 30, 2025

Study Completion

January 31, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified data will be available after study completion

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available for 5 years beginning 1 year after study completion
Access Criteria
Request to the Principal Investigator (PI) with an approved Institutional Review Board (IRB) or documentation of exemption

Locations

US(3)