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Groups for Regaining Our Wellbeing (GROW) (GROW)

Primary Purpose

Posttraumatic Stress Disorder, Depression

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Cognitive Processing Therapy
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring mindfulness, behavior therapies, cognitive, posttraumatic stress disorder, group therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans with current DSM-V diagnosis of PTSD

Exclusion Criteria:

  • Current substance use disorder other than alcohol,
  • Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by past month appointment attendance record in CPRS,
  • Suicidal or homicidal ideation with intent or plan within the past 3 months,
  • Self harm in the past 3 months,
  • A psychotic disorder,
  • Uncontrolled bipolar disorder,
  • Chart diagnoses of borderline personality disorder or antisocial personality disorder,
  • In-patient admission for psychiatric reasons within the past month,
  • Prior participation in MBSR or CPT.

Sites / Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction (MBSR)

Cognitive Processing Therapy

Arm Description

An 8-week program designed to teach mindfulness skills

A group-administered PTSD treatment program.

Outcomes

Primary Outcome Measures

PTSD symptoms
Clinician-administered PTSD Scale (CAPS)

Secondary Outcome Measures

Health-related Quality of Life
SF-36V

Full Information

First Posted
October 23, 2013
Last Updated
July 1, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01971541
Brief Title
Groups for Regaining Our Wellbeing (GROW)
Acronym
GROW
Official Title
A Non-inferiority Trial of MBSR and CPT for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study is a randomized, controlled trial that will assess whether two group interventions for PTSD - Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing Therapy-Cognitive only (CPT-C) result in similar improvements in PTSD symptoms and health-related quality of life (QOL). One hundred fifty-two Veterans with PTSD will be randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place post-treatment and 3 months later.
Detailed Description
The proposed study is a randomized, controlled non-inferiority trial that will assess whether Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing Therapy-Cognitive only (CPT-C) result in equivalent improvement in both PTSD symptoms and health-related quality of life (QOL). PTSD symptoms will be measured by the Clinician Administered PTSD Scale - CAPS and health-related QOL will be measured by the SF-36V Mental Component Summary Score - MCS. In an exploratory aim, we will also assess whether there is a clinically meaningful response as defined by improvement in both PTSD symptoms and QOL (defined as a reliable change of 12 points on the CAPS and 10 points on the MCS, respectively, according to the reliable change index).7, 8 One hundred fifty-two Veterans with PTSD will be randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place post-treatment and 3 months later. Qualitative analysis of brief semi-structured interview data will be used to identify previously unrecognized factors pertaining to participation, adherence and response to treatment, spirituality and religion as treatment moderators, and to identify common themes that may inform treatment retention efforts for both MBSR and CPT-C. In addition, potential moderators of change in PTSD symptoms and QOL for MBSR and CPT-C will be identified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression
Keywords
mindfulness, behavior therapies, cognitive, posttraumatic stress disorder, group therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
An 8-week program designed to teach mindfulness skills
Arm Title
Cognitive Processing Therapy
Arm Type
Active Comparator
Arm Description
A group-administered PTSD treatment program.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
A validated 8-week group program that teaches mindfulness meditation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
A validated group program of PTSD treatment, which focuses on cognitive processing.
Primary Outcome Measure Information:
Title
PTSD symptoms
Description
Clinician-administered PTSD Scale (CAPS)
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Health-related Quality of Life
Description
SF-36V
Time Frame
3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans with current DSM-V diagnosis of PTSD Exclusion Criteria: Current substance use disorder other than alcohol, Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by past month appointment attendance record in CPRS, Suicidal or homicidal ideation with intent or plan within the past 3 months, Self harm in the past 3 months, A psychotic disorder, Uncontrolled bipolar disorder, Chart diagnoses of borderline personality disorder or antisocial personality disorder, In-patient admission for psychiatric reasons within the past month, Prior participation in MBSR or CPT.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Kearney, MD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Groups for Regaining Our Wellbeing (GROW)

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