Mindfulness-Based Cognitive Therapy + Safety Planning For Suicidal Behavior

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Behavioral: MBCT+SPI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT+SPI<br>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<br>* 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.<br>* Other names: Safety Planning Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Beck Depression Inventory (BDI-II) | Effectiveness | baseline and post-treatment (at 9 weeks) |