NCT01607632

Brief Summary

A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

May 23, 2012

Last Update Submit

May 24, 2012

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stressdepression

Outcome Measures

Primary Outcomes (2)

  • change in PTSD symptoms

    The PTSD symptom-scale interview was performed

    baseline, post-intervention, 3-month follow-up

  • change in depressive symptoms

    The PROMIS measure for depression was administered

    baseline, post-intervention, 3-month follow-up

Study Arms (1)

loving-kindness meditation

EXPERIMENTAL
Behavioral: loving-kindness meditation

Interventions

loving-kindness meditationBEHAVIORAL

A 12-week duration, 90 minute per session loving-kindness meditation course

loving-kindness meditation

Eligibility Criteria

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

You may qualify if:

  • posttraumatic stress disorder

You may not qualify if:

  • psychosis
  • borderline personality disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • David Kearney, MD

    VA Puget Sound

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 30, 2012

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(1)