Mindfulness-Based Cognitive Therapy for Suicide Prevention

NCT ID: NCT01872338

Last Updated: 2020-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-01

Study Completion Date

2019-04-03

Brief Summary

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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

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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.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Based Cognitive Therapy + Treatment As Usual

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

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Cognitive Therapy for Suicide

Intervention Type BEHAVIORAL

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

Treatment As Usual

VA standard care for suicide prevention

Group Type OTHER

Treatment as usual

Intervention Type BEHAVIORAL

VA standard care for suicide prevention

Interventions

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Mindfulness-Based Cognitive Therapy for Suicide

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

Intervention Type BEHAVIORAL

Treatment as usual

VA standard care for suicide prevention

Intervention Type BEHAVIORAL

Other Intervention Names

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MBCT-S

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Interian, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

East Orange, New Jersey, United States

Site Status

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

Lyons, New Jersey, United States

Site Status

Countries

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United States

References

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Interian A, Miller R, Dave C, Latorre M, St Hill L, King A, Boschulte DR, Kline A, Siegel D, Sedita MM, Chesin MS. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness (N Y). 2024 Jun 18;15:1701-1712.

Reference Type DERIVED
PMID: 40134457 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34464524 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IIR 12-134

Identifier Type: -

Identifier Source: org_study_id

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