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Completed

NCT Number: NCT01826240

Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Columbia University/New York State Psychiatric Institute

New York, 10032, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBCT+SPI

Behavioral

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

Primary outcomes

  1. Retention

    Time frame: participants will be followed for the duration of treatment, an expected average of 9 weeks

    Feasibility

  2. Consumer Satisfaction Questionnaire

    Time frame: post-treatment (at 9 weeks)

    Acceptability

  3. 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

    Safety

Secondary outcomes

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

    Time frame: baseline and post-treatment (at 9 weeks)

    Effectiveness

Other outcomes

  1. Change in cognitive processes underlying treatment gains

    Time frame: baseline and post-treatment (at 9 weeks)

    neuropsychological tasks assessing attention and other cognitive processes

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • American Foundation for Suicide Prevention

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2013
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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