Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01826240
First received: March 13, 2013
Last updated: August 29, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Monopolar Depression, Single Episode or Unspecified
Suicidal and Self-injurious Behaviour
Behavioral: MBCT+SPI
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior: A Treatment Development Study

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Retention [ Time Frame: participants will be followed for the duration of treatment, an expected average of 9 weeks ] [ Designated as safety issue: No ]
    Feasibility

  • Consumer Satisfaction Questionnaire [ Time Frame: post-treatment (at 9 weeks) ] [ Designated as safety issue: No ]
    Acceptability

  • Change in scores on Scale for Suicide Ideation [ Time Frame: participants will be followed for the duration of treatment, an expected average of 9 weeks ] [ Designated as safety issue: Yes ]
    Safety


Secondary Outcome Measures:
  • Change in scores on Beck Depression Inventory (BDI-II) [ Time Frame: baseline and post-treatment (at 9 weeks) ] [ Designated as safety issue: No ]
    Effectiveness


Other Outcome Measures:
  • Change in cognitive processes underlying treatment gains [ Time Frame: baseline and post-treatment (at 9 weeks) ] [ Designated as safety issue: No ]
    neuropsychological tasks assessing attention and other cognitive processes


Estimated Enrollment: 24
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826240

Locations
United States, New York
Columbia University/New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
American Foundation for Suicide Prevention
Investigators
Principal Investigator: Megan Chesin, Ph.D. Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01826240     History of Changes
Other Study ID Numbers: 6592, PDF-0-076-11
Study First Received: March 13, 2013
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 24, 2014