A Mindfulness-Based Cognitive Therapy for Suicidal Patients

• ClinicalTrials.gov Identifier: NCT05158920
• Recruitment Status: Completed
• First Posted: December 15, 2021
• Last Update Posted: January 10, 2022
• Sponsor: University Ghent
• Information provided by (Responsible Party): University Ghent

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Suicidal Ideation; Suicide Attempt	Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial Investigating the Effectiveness of Mindfulness-Based Cognitive Therapy for Suicidal Patients
• Actual Study Start Date: April 11, 2017
• Actual Primary Completion Date: March 2, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Suicidal ideation: The Beck Scale for Suicide Ideation [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   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.

Secondary Outcome Measures :

1. Depressive symptoms: The second edition of the Beck Depression Inventory [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   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.
2. Hopelessness: The Beck Hopelessness Scale [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   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.
3. Defeat: the Defeat Scale [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   A 16-item self-report questionnaire to measure defeat on a five-point Likert scale.
4. Entrapment: the Entrapment Scale [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale.
5. Worrying: The Penn State Worry Questionnaire - past week [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   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").
6. Mindfulness: Five Facet Mindfulness Questionnaire [ Time Frame: Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment) ]
   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.

Other Outcome Measures:

1. Treatment evaluation [ Time Frame: Posttest (2 months after baseline assessment) ]
   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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Belgium

Unit for Suicide Research, Ghent University

Ghent, Belgium, 9000

Sponsors and Collaborators

University Ghent

Investigators

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

More Information

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT05158920
• Other Study ID Numbers: EC/20160609/MBCT
• First Posted: December 15, 2021
• Last Update Posted: January 10, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicide; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Behavioral Symptoms