A Mindfulness-Based Cognitive Therapy for Suicidal Patients

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158920
• Other study ID #: EC/20160609/MBCT
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: May 31, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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).

Locations

Country	Name	City	State
Belgium	Unit for Suicide Research, Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment evaluation	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	Posttest (2 months after baseline assessment)
Primary	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.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	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.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	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.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	Defeat: the Defeat Scale	A 16-item self-report questionnaire to measure defeat on a five-point Likert scale.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	Entrapment: the Entrapment Scale	A 16-item self-report questionnaire to measure entrapment on a five-point Likert scale.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	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").	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)
Secondary	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.	Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)