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A Mindfulness-Based Cognitive Therapy for Suicidal Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05158920
Recruitment Status : Completed
First Posted : December 15, 2021
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
University Ghent

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05158920


Locations
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Belgium
Unit for Suicide Research, Ghent University
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Gwendolyn Portzky, Prof. Dr. University Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT05158920    
Other Study ID Numbers: EC/20160609/MBCT
First Posted: December 15, 2021    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms