A Mindfulness-Based Cognitive Therapy for Suicidal Patients

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT05158920
Collaborator
(none)
157
1
2
13.6
11.5

Study Details

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
  • Behavioral: Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)
N/A

Study Design

Study Type:
Interventional
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)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 :
Apr 11, 2017
Actual Primary Completion Date :
Mar 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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Unit for Suicide Research, Ghent University Ghent Belgium 9000

Sponsors and Collaborators

  • University Ghent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT05158920
Other Study ID Numbers:
  • EC/20160609/MBCT
First Posted:
Dec 15, 2021
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Jan 10, 2022