Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

Phase 1

Completed

• Conditions: Monopolar Depression, Single Episode or Unspecified; Suicidal and Self-injurious Behaviour
• Interventions: Behavioral: MBCT+SPI

• Registration Number: NCT01826240
• Lead Sponsor: New York State Psychiatric Institute

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

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBCT+SPI	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in scores on Beck Depression Inventory (BDI-II)	baseline and post-treatment (at 9 weeks)	Effectiveness

Trial Locations

Locations (1)

Columbia University/New York State Psychiatric Institute; 🇺🇸 New York, New York, United States