A Mindfulness-Based Cognitive Therapy for Suicidal Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide Attempt
• Intervention / Treatment: Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Unit for Suicide Research, Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants in the control group received their treatment as usual.
Experimental: Intervention Group; 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); 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).

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment evaluation	Rating of the general training (score ranging from 0 to 10) and 10 statements about several aspects of the format, content and effect of the group treatment. Of these statements, 5 were rated on a 3-point Likert scale, and 5 on a 5-point likert scale	Posttest (2 months after baseline assessment)

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Gwendolyn Portzky, Prof. Dr., University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): March 2, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: EC/20160609/MBCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No