A Mindfulness-Based Cognitive Therapy for Suicidal Patients
Primary Purpose
Suicidal Ideation, Suicide Attempt
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Ideation
Eligibility 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
Sites / Locations
- Unit for Suicide Research, Ghent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Participants in the intervention group received Mindfulness-Based Cognitive Therapy in addition to their treatment as usual.
Participants in the control group received their treatment as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Defeat: the Defeat Scale
A 16-item self-report questionnaire to measure defeat on a five-point Likert scale.
Entrapment: the Entrapment Scale
A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale.
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").
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05158920
Brief Title
A Mindfulness-Based Cognitive Therapy for Suicidal Patients
Official Title
Randomized Controlled Trial Investigating the Effectiveness of Mindfulness-Based Cognitive Therapy for Suicidal Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide Attempt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in the intervention group received Mindfulness-Based Cognitive Therapy in addition to their treatment as usual.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group received their treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Suicidal ideation: The Beck Scale for Suicide Ideation
Description
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.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary Outcome Measure Information:
Title
Depressive symptoms: The second edition of the Beck Depression Inventory
Description
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.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Title
Hopelessness: The Beck Hopelessness Scale
Description
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.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Title
Defeat: the Defeat Scale
Description
A 16-item self-report questionnaire to measure defeat on a five-point Likert scale.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Title
Entrapment: the Entrapment Scale
Description
A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Title
Worrying: The Penn State Worry Questionnaire - past week
Description
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").
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Title
Mindfulness: Five Facet Mindfulness Questionnaire
Description
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.
Time Frame
Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Other Pre-specified Outcome Measures:
Title
Treatment evaluation
Description
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
Time Frame
Posttest (2 months after baseline assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, Prof. Dr.
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Suicide Research, Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Mindfulness-Based Cognitive Therapy for Suicidal Patients
We'll reach out to this number within 24 hrs