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

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Mindfulness-Based Cognitive Therapy for Suicide; Behavioral: Treatment as usual

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
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
    • Lyons, New Jersey, United States, 07939
      • Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: MBCT-S
Other: Treatment As Usual; VA standard care for suicide prevention	Behavioral: Treatment as usual; VA standard care for suicide prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-months post-baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Columbia University; Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Veterans; mindfulness meditation; suicide prevention; safety planning; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: IIR 12-134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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