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Completed

NCT Number: NCT01872338

Mindfulness-Based Cognitive Therapy for Suicide Prevention

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy for Suicide

Behavioral

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

Other names: MBCT-S

Treatment as Usual

Behavioral

VA standard care for suicide prevention

Primary outcomes

  1. Suicide Event

    Time frame: 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 outcomes

  1. Suicide Attempt

    Time frame: 12 months post-baseline

    Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent

  2. Suicidal Ideation

    Time frame: 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.

  3. Hopelessness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Columbia University
  • Rutgers, The State University of New Jersey

Registry information

Official study title

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans

Acronym: MBCT-S

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2013
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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