Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

NCT01826240 | Completed Phase 1

• 2 other identifiers: 6592PDF-0-076-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  baseline and post-treatment (at 9 weeks)

Other Outcomes (1)

• Change in cognitive processes underlying treatment gains

  baseline and post-treatment (at 9 weeks)

Study Arms (1)

MBCT+SPI

EXPERIMENTAL

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

Interventions

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.

Also known as: Mindfulness-Based Cognitive Therapy, Safety Planning Intervention

MBCT+SPI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Columbia University/New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression; Self-Injurious Behavior

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Megan Chesin, Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 4, 2015

Record last verified: 2013-04

Locations

US (1)