NCT01548742

Brief Summary

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

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

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 10, 2015

Completed
Last Updated

December 10, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

March 5, 2012

Results QC Date

September 29, 2015

Last Update Submit

November 4, 2015

Conditions

Stress Disorders, Post-Traumatic

Keywords

Meditation

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up

    The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.

    Baseline, Weeks 3, 6, 9 and 17

Secondary Outcomes (2)

  • PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up

    Baseline, Weeks 9 and 17

  • Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up

    Baseline, Weeks 9 and 17

Other Outcomes (2)

  • Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL

    Weeks 9 and 17

  • Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)

    Weeks 9 and 17

Study Arms (2)

Arm 1: Mindfulness-Based Stress Reduction (MBSR)

EXPERIMENTAL

Mindfulness-Based Stress Reduction (MBSR)

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Arm 2: Present-Centered Group Therapy (PCGT)

ACTIVE COMPARATOR

Present-Centered Group Therapy (PCGT)

Behavioral: Present-Centered Group Therapy (PCGT)

Interventions

Mindfulness-Based Stress Reduction (MBSR)BEHAVIORAL

Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.

Also known as: MBSR
Arm 1: Mindfulness-Based Stress Reduction (MBSR)
Present-Centered Group Therapy (PCGT)BEHAVIORAL

Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.

Arm 2: Present-Centered Group Therapy (PCGT)

Eligibility Criteria

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

You may qualify if:

  • Male or female veterans who are 18 years or older.
  • Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS) or have a PTSD Checklist (PCL) score between 40 and 60.
  • If taking psychoactive medications, must be on a stable regime for 8 weeks or more.

You may not qualify if:

  • Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  • Current substance dependence (not in sustained remission), current or recent (within past 6 months) manic episode, or active psychosis. To be eligible, if veteran has current diagnosis of bipolar disorder, there is evidence that illness has been stable for at least 6 months on medication. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease that would interfere with participation in treatment.
  • Severe cognitive impairment or moderate/severe traumatic brain injury.
  • Unable to comprehend or communicate in English.
  • Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (3)

  • Shapira I, Richman J, Pace TWW, Lim KO, Polusny MA, Hamner MB, Bremner JD, Mumba MN, Jacobs ML, Pilkinton P, Davis LL. Biomarker Response to Mindfulness Intervention in Veterans Diagnosed with Post-traumatic Stress Disorder. Mindfulness (N Y). 2022 Oct;13(10):2448-2460. doi: 10.1007/s12671-022-01969-6. Epub 2022 Sep 12.

    PMID: 36938380DERIVED

  • Kang SS, Sponheim SR, Lim KO. Interoception Underlies Therapeutic Effects of Mindfulness Meditation for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Aug;7(8):793-804. doi: 10.1016/j.bpsc.2021.10.005. Epub 2021 Oct 21.

    PMID: 34688923DERIVED

  • Polusny MA, Erbes CR, Thuras P, Moran A, Lamberty GJ, Collins RC, Rodman JL, Lim KO. Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):456-65. doi: 10.1001/jama.2015.8361.

    PMID: 26241597DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Initial analyses did not account for clustering effects. However, when we re-analyzed data using a multilevel model including a random effect for therapy group, we found that the results were essentially unchanged.

Results Point of Contact

Title
Kelvin O. Lim, MD (Principal Investigator)
Organization
Minneapolis VA Medical Center
kolim@umn.edu
612-467-3323

Study Officials

  • Kelvin Lim, MD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 10, 2015

Results First Posted

December 10, 2015

Record last verified: 2015-11

Locations

US(1)