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NCT Number: NCT05158920

A Mindfulness-Based Cognitive Therapy for Suicidal Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unit for Suicide Research, Ghent University

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy for Suicidal individuals (MBCT-S)

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Randomized Controlled Trial Investigating the Effectiveness of Mindfulness-Based Cognitive Therapy for Suicidal Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2021
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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