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A Mindfulness-Based Cognitive Therapy for Suicidal Patients

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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

Tracking Information
First Submitted Date  ICMJE December 2, 2021
First Posted Date  ICMJE December 15, 2021
Last Update Posted Date January 10, 2022
Actual Study Start Date  ICMJE April 11, 2017
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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").
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2021)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Mindfulness-Based Cognitive Therapy for Suicidal Patients
Official Title  ICMJE Randomized Controlled Trial Investigating the Effectiveness of Mindfulness-Based Cognitive Therapy for Suicidal Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Suicidal Ideation
  • Suicide Attempt
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Experimental: Intervention Group
    Participants in the intervention group received Mindfulness-Based Cognitive Therapy in addition to their treatment as usual.
    Intervention: Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)
  • No Intervention: Control Group
    Participants in the control group received their treatment as usual.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2021)
157
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05158920
Other Study ID Numbers  ICMJE EC/20160609/MBCT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Ghent
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Ghent
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gwendolyn Portzky, Prof. Dr. University Ghent
PRS Account University Ghent
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP