Posttraumatic Stress DisorderPhase 2/3GROWNCT01971541
Groups for Regaining Our Wellbeing (GROW)
A Phase 2/3 study testing Mindfulness-Based Stress Reduction and Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Depression, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Mindfulness-Based Stress Reduction and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with current DSM-V diagnosis of PTSD
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: A Non-inferiority Trial of MBSR and CPT for PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Mindfulness-Based Stress Reduction, Cognitive Processing Therapy
- Keywords
- mindfulness, behavior therapies, cognitive, posttraumatic stress disorder, group therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
A validated 8-week group program that teaches mindfulness meditation
Cognitive Processing TherapyBehavioural
Also called CPT
A validated group program of PTSD treatment, which focuses on cognitive processing.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | An 8-week program designed to teach mindfulness skills Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Cognitive Processing Therapy | Active comparator | A group-administered PTSD treatment program. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
Clinician-administered PTSD Scale (CAPS)
Measured: 3 months follow-up
Secondary outcomes (1)
Health-related Quality of Life
SF-36V
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David J. Kearney, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971541
- Sponsor's protocol ID
- IIR 12-112
- Acronym
- GROW
- Status last verified
- Jul 2014
- First submitted
- 23 Oct 2013
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-inferiority Trial of MBSR and CPT for PTSD
- ClinicalTrials.gov ID
- NCT01971541
- Acronym / sponsor ID
- GROW / IIR 12-112
- Conditions
- Posttraumatic Stress Disorder, Depression
- Keywords
- mindfulness, behavior therapies, cognitive, posttraumatic stress disorder, group therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness-Based Stress ReductionAn 8-week program designed to teach mindfulness skills |
| Cognitive Processing Therapy | Active comparator | Behavioral: Cognitive Processing TherapyA group-administered PTSD treatment program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with current DSM-V diagnosis of PTSD
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSRA validated 8-week group program that teaches mindfulness meditation | Behavioural | Mindfulness-Based Stress Reduction (MBSR) |
| Cognitive Processing TherapyAlso: CPTA validated group program of PTSD treatment, which focuses on cognitive processing. | Behavioural | Cognitive Processing Therapy |
Primary outcome
PTSD symptoms
Time frame: 3 months follow-up
Clinician-administered PTSD Scale (CAPS)
1 secondary outcome
Health-related Quality of Life
Time frame: 3 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Kearney, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mindfulness-Based Stress Reduction and Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Depression, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (time frame: 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.