Clinical trial NCT01872338: Mindfulness-Based Cognitive Therapy for Suicide Prevention
Official title: Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: suicide prevention
mindfulness-based cognitive therapy
mindfulness meditation
Veterans
safety planning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Columbia University
name: Rutgers, The State University of New Jersey
First posted: 2013-06-07
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suicide Event
timeFrame: 12-months post-baseline
Secondary outcomes:
measure: Suicide Attempt
timeFrame: 12 months post-baseline
measure: Suicidal Ideation
timeFrame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
measure: Hopelessness
timeFrame: Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline
Other outcomes:
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
city: Lyons
country: United States
facility: Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
state: New Jersey
Study officials:
affiliation: Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ
name: Alejandro Interian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.