Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

Suicidal and Self-injurious Behaviour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826240
• Other study ID #: 6592
• Secondary ID: PDF-0-076-11
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: December 3, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Monopolar Depression, Single Episode or Unspecified
• Self-Injurious Behavior
• Suicidal and Self-injurious Behaviour

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University/New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	American Foundation for Suicide Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cognitive processes underlying treatment gains	neuropsychological tasks assessing attention and other cognitive processes	baseline and post-treatment (at 9 weeks)	No
Primary	Retention	Feasibility	participants will be followed for the duration of treatment, an expected average of 9 weeks	No
Primary	Consumer Satisfaction Questionnaire	Acceptability	post-treatment (at 9 weeks)	No
Primary	Change in scores on Scale for Suicide Ideation	Safety	participants will be followed for the duration of treatment, an expected average of 9 weeks	Yes
Secondary	Change in scores on Beck Depression Inventory (BDI-II)	Effectiveness	baseline and post-treatment (at 9 weeks)	No