Mindfulness-Based Cognitive Therapy for Suicide Prevention

Suicide Clinical Trial

— MBCT-S  

Official title:

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872338
• Other study ID #: IIR 12-134
• Status: Completed
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: April 3, 2019

Study information

• Verified date: April 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy for Suicide
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

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Columbia University, Rutgers University Bloustein Center for Survey Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Suicide Attempt	Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent	12 months post-baseline
Secondary	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
Secondary	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