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Mindfulness-Based Cognitive Therapy for Suicide Prevention (MBCT-S)

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ClinicalTrials.gov Identifier: NCT01872338
Recruitment Status : Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
Columbia University
Rutgers University Bloustein Center for Survey Research
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to test a psychotherapeutic intervention that integrates cognitive therapy and mindfulness meditation techniques to prevent suicide in military Veterans.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Mindfulness-Based Cognitive Therapy for Suicide Behavioral: Treatment as usual Not Applicable

Detailed Description:
Every month the VA becomes aware of approximately 1,100 Veterans in VA care who attempt suicide. While the VA has implemented a comprehensive, multifaceted suicide prevention approach, it has yet to implement nationally any evidence-based psychotherapies targeting suicide, a gap due largely to the dearth of evidence-based therapies for suicide. Primary aims of this proposal are to conduct a randomized controlled trial testing an adaptation of a cognitive-behavioral intervention, Mindfulness-Based Cognitive Therapy (MBCT), for Veterans on the VA's High Risk for Suicide List. The investigators' adapted version of MBCT for suicide (MBCT-S) integrates mindfulness meditation techniques with the VA Safety Plan to enhance patients' awareness of suicide triggers and appropriate coping strategies. This study has the potential to increase the range of cost effective treatment alternatives for the large number of suicidal Veterans for whom evidence-based therapies are severely limited.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans
Actual Study Start Date : December 1, 2013
Estimated Primary Completion Date : April 3, 2019
Estimated Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Active Comparator: Mindfulness-Based Cognitive Therapy + Treatment As Usual
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
Behavioral: Mindfulness-Based Cognitive Therapy for Suicide
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
Other Name: MBCT-S

Treatment As Usual
VA standard care for suicide prevention
Behavioral: Treatment as usual
VA standard care for suicide prevention




Primary Outcome Measures :
  1. Suicide event [ Time Frame: Change from baseline at 4 weeks, 8 weeks, 6 months and 12-months post-baseline ]
    The investigators define "event" broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization.


Secondary Outcome Measures :
  1. Suicide attempt [ Time Frame: 12 months post-baseline ]
    defined as either actual or aborted/interrupted suicide attempt.

  2. Suicide ideation [ Time Frame: 12 months post-baseline ]
    Ideation will be measured using the Columbia Suicide Severity Rating Scale (CSSRS) and will include 5 ideation types: general wish to be dead, non-specific active suicidal thoughts, active thoughts with method, active thoughts with intent, and active thoughts with intent and plan.

  3. Hopelessness [ Time Frame: 4 weeks, 8 weeks, 6 months and 12-months post-baseline ]
    Hopelessness will be measured using the Beck Hopelessness Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following criteria were formulated to recruit a sample at high risk for suicide behavior.

  • The subject has experienced a suicidal event during the past 30 days. A suicidal event involves

    • 1) psychiatric hospitalization due to suicidal risk,
    • 2) psychiatric hospitalization if subject was already on the High Risk for Suicide List,
    • 3) suicidal ideation with suicidal intent,
    • 4) suicidal preparatory behaviors, or
    • 5) actual, interrupted, or aborted suicide attempt.

AND

  • The subject is on or will be placed on the VA High Risk for Suicide List

    • OR The subject had an actual, interrupted, or aborted attempt in the last year
    • OR In the study clinician's opinion (i.e., Masters or Doctoral level study personnel with formal mental health training) in consultation with the PI, the suicidal event is significant enough to warrant treatment to reduce suicidal risk.

Exclusion Criteria:

  • cognitive deficits that decrease the likelihood of benefit from MBCT-S
  • severe symptoms of hallucinations or delusions
  • disorganized or disruptive behaviors
  • medically unstable
  • current mindfulness-based psychotherapy or receipt of 2 or more sessions of a mindfulness-based psychotherapy in the last 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872338


Locations
United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
Lyons, New Jersey, United States, 07939
Sponsors and Collaborators
VA Office of Research and Development
Columbia University
Rutgers University Bloustein Center for Survey Research
Investigators
Principal Investigator: Alejandro Interian, PhD Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01872338     History of Changes
Other Study ID Numbers: IIR 12-134
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
suicide prevention
minfulness-based cognitive therapy
mindfulness meditation
Veterans
safety planning

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms