NCT01872338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 22, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

5.3 years

First QC Date

May 10, 2013

Results QC Date

April 8, 2020

Last Update Submit

April 22, 2020

Conditions

Keywords

suicide preventionmindfulness-based cognitive therapymindfulness meditationVeteranssafety planning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Suicide Attempt

    12 months post-baseline

  • Suicidal Ideation

    Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

  • Hopelessness

    Baseline, 4 weeks (mid-treatment), 8 weeks (treatment-completion), 6 months and 12-months post-baseline

Study Arms (2)

Mindfulness-Based Cognitive Therapy + Treatment As Usual

ACTIVE COMPARATOR

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

Behavioral: Mindfulness-Based Cognitive Therapy for Suicide

Treatment As Usual

OTHER

VA standard care for suicide prevention

Behavioral: Treatment as usual

Interventions

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

Also known as: MBCT-S
Mindfulness-Based Cognitive Therapy + Treatment As Usual

VA standard care for suicide prevention

Treatment As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • \) psychiatric hospitalization due to suicidal risk,
  • \) psychiatric hospitalization if subject was already on the High Risk for Suicide List,
  • \) suicidal ideation with suicidal intent,
  • \) suicidal preparatory behaviors, or
  • \) 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

East Orange, New Jersey, 07018, United States

Location

Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

Lyons, New Jersey, 07939, United States

Location

Related Publications (2)

  • Interian A, Miller R, Dave C, Latorre M, St Hill L, King A, Boschulte DR, Kline A, Siegel D, Sedita MM, Chesin MS. Examining the Occurrence and Clinical Impact of Difficult Experiences that Emerge during a Mindfulness-Based Intervention among Individuals at High-Risk of Suicide. Mindfulness (N Y). 2024 Jun 18;15:1701-1712.

  • 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.

MeSH Terms

Conditions

SuicideSuicide Prevention

Interventions

Mindfulness-Based Cognitive TherapyTherapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Alejandro Interian, PHD
Organization
VA New Jersey Healthcare System

Study Officials

  • Alejandro Interian, PhD

    Lyons Campus of the VA New Jersey Health Care System, Lyons, NJ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

June 7, 2013

Study Start

December 1, 2013

Primary Completion

April 3, 2019

Study Completion

April 3, 2019

Last Updated

May 5, 2020

Results First Posted

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations