Clinical trial NCT01826240: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Monopolar Depression, Single Episode or Unspecified
Suicidal and Self-injurious Behaviour
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2013-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Retention
timeFrame: participants will be followed for the duration of treatment, an expected average of 9 weeks
measure: Consumer Satisfaction Questionnaire
timeFrame: post-treatment (at 9 weeks)
measure: Change in scores on Scale for Suicide Ideation
timeFrame: participants will be followed for the duration of treatment, an expected average of 9 weeks
Secondary outcomes:
measure: Change in scores on Beck Depression Inventory (BDI-II)
timeFrame: baseline and post-treatment (at 9 weeks)
Other outcomes:
measure: Change in cognitive processes underlying treatment gains
timeFrame: baseline and post-treatment (at 9 weeks)
Locations:
city: New York
country: United States
facility: Columbia University/New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Megan Chesin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: