A Mindfulness-Based Cognitive Therapy for Suicidal Patients

NCT05158920 | Completed

• 1 other identifier: EC/20160609/MBCT
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide Attempt

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

• Hopelessness: The Beck Hopelessness Scale

  Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)

• Defeat: the Defeat Scale

  Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)

• Entrapment: the Entrapment Scale

  Baseline (2 weeks before the intervention), posttest (2 months after baseline assessment), follow-up (5 months after baseline assessment)

• 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)

Other Outcomes (1)

• Treatment evaluation

  Posttest (2 months after baseline assessment)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

Participants in the control group received their treatment as usual.

Interventions

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).

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Conditions expected to severely hinder group participation, comprehension of the training content or adherence

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Unit for Suicide Research, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gwendolyn Portzky, Prof. Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial comparing an experimental condition (Treatment As Usual + Mindfulness-Based Cognitive Therapy) and a control condition (Treatment As Usual)

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: April 11, 2017
• Primary Completion: March 2, 2018
• Study Completion: May 31, 2018
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)