A Mindfulness-Based Cognitive Therapy for Suicidal Patients

Study Overview
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Brief Summary
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The main goal of this study is to evaluate the effectiveness ofMindfulness-Based Cognitive Therapy aimed at reducing suicidality in adults. This will test the effectiveness by studying the effect on suicidal ideation and related outcomes, compared to Treatment As Usual. The study is a multicentre randomized controlled trial conducted in out-patient Flemish mental healthcare facilities.

Official Title
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Randomized Controlled Trial Investigating the Effectiveness of Mindfulness-Based Cognitive Therapy for Suicidal Patients

Conditions
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Suicidal Ideation, Suicide Attempt

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Speak Dutch Be at least 18 years old Have access to internet Be suitable for group therapy Have mild to severe suicidal thoughts (BSS score of minimum 1) Exclusion Criteria: Conditions expected to severely hinder group participation, comprehension of the training content or adherence

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial comparing an experimental condition (Treatment As Usual + Mindfulness-Based Cognitive Therapy) and a control condition (Treatment As Usual)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in the intervention group received Mindfulness-Based Cognitive Therapy in addition to their treatment as usual. | Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)<br>* MBCT-S is a group intervention of 8 weekly sessions of 2 hours combining techniques of mindfulness with important elements of cognitive therapy (e.g. safety plan and homework).<br>|
| No Intervention: Control Group<br>Participants in the control group received their treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal ideation: The Beck Scale for Suicide Ideation | A 21-item self-report questionnaire to measure (the severity of) suicidal ideation in adolescents and adults. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38, with higher scores indicating more (severe) suicidal ideation. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms: The second edition of the Beck Depression Inventory | A 21-item self-report questionnaire to measure depressive symptoms and attitudes in the past week. Each item is rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63, with higher scores indicating more depressive symptoms. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 
| Hopelessness: The Beck Hopelessness Scale | A 20-item self-report questionnaire to measure hopelessness in adolescents and adults. Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 20, with higher scores indicating higher levels of hopelessness. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 
| Defeat: the Defeat Scale | A 16-item self-report questionnaire to measure defeat on a five-point Likert scale. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 
| Entrapment: the Entrapment Scale | A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 
| Worrying: The Penn State Worry Questionnaire - past week | A 15-item self-report questionnaire to measure worrying in the past week. Each item is rated on a 7-point Likert scale ranging from 0 (never) to 6 (almost always). | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) | 
| Mindfulness: Five Facet Mindfulness Questionnaire | A 24-item self-report questionnaire to measure five distinct facets of mindfulness: observing, describing, acting with awareness, nonjudging and nonreactivity. Each item is rated on a 5-point Likert scale ranging from 1 (never/very rarely true) to 5 (very often/always true), resulting in a total score ranging from 1 to 120. | Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) |