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

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy for Suicide
Treatment as usual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring suicide prevention, mindfulness-based cognitive therapy, mindfulness meditation, Veterans, safety planning

Eligibility Criteria

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

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

Sites / Locations

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  • Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Mindfulness-Based Cognitive Therapy + Treatment As Usual

Treatment As Usual

Arm Description

Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.

VA standard care for suicide prevention

Outcomes

Primary Outcome Measures

Suicide Event
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

Suicide Attempt
Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent
Suicidal Ideation
clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.
Hopelessness
Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.

Full Information

First Posted
May 10, 2013
Last Updated
April 22, 2020
Sponsor
VA Office of Research and Development
Collaborators
Columbia University, Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01872338
Brief Title
Mindfulness-Based Cognitive Therapy for Suicide Prevention
Acronym
MBCT-S
Official Title
Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Columbia University, Rutgers, The State University of New Jersey

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
suicide prevention, mindfulness-based cognitive therapy, mindfulness meditation, Veterans, safety planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Cognitive Therapy + Treatment As Usual
Arm Type
Active Comparator
Arm Description
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
Arm Title
Treatment As Usual
Arm Type
Other
Arm Description
VA standard care for suicide prevention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy for Suicide
Other Intervention Name(s)
MBCT-S
Intervention Description
Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
VA standard care for suicide prevention
Primary Outcome Measure Information:
Title
Suicide Event
Description
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.
Time Frame
12-months post-baseline
Secondary Outcome Measure Information:
Title
Suicide Attempt
Description
Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent
Time Frame
12 months post-baseline
Title
Suicidal Ideation
Description
clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.
Time Frame
Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Title
Hopelessness
Description
Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.
Time Frame
Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Interian, PhD
Organizational Affiliation
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
City
Lyons
State/Province
New Jersey
ZIP/Postal Code
07939
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34464524
Citation
Interian A, Chesin MS, Stanley B, Latorre M, St Hill LM, Miller RB, King AR, Boschulte DR, Rodriguez KM, Kline A. Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. J Clin Psychiatry. 2021 Aug 31;82(5):20m13791. doi: 10.4088/JCP.20m13791.
Results Reference
derived

Learn more about this trial

Mindfulness-Based Cognitive Therapy for Suicide Prevention

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