Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior: A Treatment Development Study

The purpose of this study is to combine and adapt Mindfulness-Based Cognitive Therapy (MBCT) + Safety Planning Intervention (SPI) for individuals with suicidal behavior and to determine its feasibility, acceptability, safety and preliminary effectiveness. An exploratory aim is to collect data on the cognitive changes underlying treatment gains.

Study Overview

• Status: Completed
• Conditions: Suicidal and Self-injurious Behaviour; Monopolar Depression, Single Episode or Unspecified
• Intervention / Treatment: Behavioral: MBCT+SPI

Detailed Description

• The study is a nine-week clinical trial combining Safety Planning Intervention plus Mindfulness-Based Cognitive Therapy for patients with a recent history of suicidal thoughts or behavior and current or past depressive symptoms.
• These treatments work for depression and some preliminary data suggest they may work to prevent suicidal behavior.

• Participation includes:

  • Nine weeks of free treatment
  • Clinical assessments
  • An opportunity to offer your views on treatment and suggestions for improving the treatment in focus groups

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University/New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-65
• History of depression
• Suicidal behavior or thoughts (i.e., current suicidal thoughts at screening and history of at least one suicide attempt or suicide-related behavior (aborted or interrupted suicide attempt) or suicidal ideation with plan or method in the past 6 months)
• In active treatment (e.g., receiving psychiatric medications)

Exclusion Criteria:

• Current mania, psychosis, Obsessive-Compulsive Disorder, Traumatic Brain Damage, Organic or Acute Brain Syndrome, Mental Retardation or pervasive developmental disorder
• Requires priority treatment for an acute illness or debilitating problem such as severe primary substance dependence or anorexia nervosa
• Inability to complete psychiatric interview or group treatment due to lack of cooperation or lack of comprehension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: MBCT+SPI; Note: There is only one condition in this study. Mindfulness-Based Cognitive Therapy (MBCT) is combined with Safety Planning Intervention (SPI). All individuals who choose to participate will receive MBCT+SPI.

Behavioral: MBCT+SPI; Safety Planning Intervention (SPI), a very brief intervention focused on identifying personalized coping strategies to manage acute suicidality, is combined with Mindfulness-Based Cognitive Therapy (MBCT), a group intervention comprised of mindfulness training and cognitive therapy techniques. Treatment lasts 9 weeks.; Other Names: Mindfulness-Based Cognitive Therapy; Safety Planning Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Feasibility	participants will be followed for the duration of treatment, an expected average of 9 weeks
Consumer Satisfaction Questionnaire	Acceptability	post-treatment (at 9 weeks)
Change in scores on Scale for Suicide Ideation	Safety	participants will be followed for the duration of treatment, an expected average of 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores on Beck Depression Inventory (BDI-II)	Effectiveness	baseline and post-treatment (at 9 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive processes underlying treatment gains	neuropsychological tasks assessing attention and other cognitive processes	baseline and post-treatment (at 9 weeks)

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Megan Chesin, Ph.D., Columbia University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (ESTIMATE): April 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 6592; PDF-0-076-11 (OTHER_GRANT: American Foundation for Suicide Prevention)