Mindfulness-Based Cognitive Therapy for Suicide Prevention

Not Applicable

Completed

• Conditions: Suicide
• Interventions: Behavioral: Treatment as usual; Behavioral: Mindfulness-Based Cognitive Therapy for Suicide

• Registration Number: NCT01872338
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Study Start: 2013-12-01
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-03
• Status Verified: 2020-04
• Results First Submitted: 2020-04-08
• Results First Submitted QC: 2020-04-08
• Results First Posted: 2020-04-22
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual	Treatment as usual	VA standard care for suicide prevention
Mindfulness-Based Cognitive Therapy + Treatment As Usual	Mindfulness-Based Cognitive Therapy for Suicide	Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.

Primary Outcome Measures

Name	Time	Method
Suicide Event	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

Name	Time	Method
Suicidal Ideation	Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline	clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation.
Hopelessness	Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline	Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.
Suicide Attempt	12 months post-baseline	Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent

Trial Locations

Locations (2)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ; 🇺🇸 East Orange, New Jersey, United States

Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ; 🇺🇸 Lyons, New Jersey, United States