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Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

Primary Purpose

Monopolar Depression, Single Episode or Unspecified, Suicidal and Self-injurious Behaviour

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MBCT+SPI
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monopolar Depression, Single Episode or Unspecified

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University/New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBCT+SPI

Arm Description

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.

Outcomes

Primary Outcome Measures

Retention
Feasibility
Consumer Satisfaction Questionnaire
Acceptability
Change in scores on Scale for Suicide Ideation
Safety

Secondary Outcome Measures

Change in scores on Beck Depression Inventory (BDI-II)
Effectiveness

Full Information

First Posted
March 13, 2013
Last Updated
December 3, 2015
Sponsor
New York State Psychiatric Institute
Collaborators
American Foundation for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01826240
Brief Title
Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior
Official Title
Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior: A Treatment Development Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
American Foundation for Suicide Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monopolar Depression, Single Episode or Unspecified, Suicidal and Self-injurious Behaviour

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT+SPI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MBCT+SPI
Other Intervention Name(s)
Mindfulness-Based Cognitive Therapy, Safety Planning Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention
Description
Feasibility
Time Frame
participants will be followed for the duration of treatment, an expected average of 9 weeks
Title
Consumer Satisfaction Questionnaire
Description
Acceptability
Time Frame
post-treatment (at 9 weeks)
Title
Change in scores on Scale for Suicide Ideation
Description
Safety
Time Frame
participants will be followed for the duration of treatment, an expected average of 9 weeks
Secondary Outcome Measure Information:
Title
Change in scores on Beck Depression Inventory (BDI-II)
Description
Effectiveness
Time Frame
baseline and post-treatment (at 9 weeks)
Other Pre-specified Outcome Measures:
Title
Change in cognitive processes underlying treatment gains
Description
neuropsychological tasks assessing attention and other cognitive processes
Time Frame
baseline and post-treatment (at 9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Chesin, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University/New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

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