Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts

Not Applicable

Active, not recruiting

• Conditions: Suicide, Attempt; Suicidal Ideation

• Registration Number: NCT02664701
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to evaluate the efficacy of a program of 6 sessions of Cognitive Behavioural Group Therapy (CBGT) (as compared to 6 sessions of Individual Supportive Therapy (IST)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.

Detailed Description

The secondary objectives of this study are to assess the efficacy of CBGT on:

A. parameters describing the incidence of suicide and repeat suicide attempts, as well as suicide re-attempt free follow-up time,

B. long-term changes in suicidal ideation,

C. long-term changes in psychiatric symptoms (depression, hope for the future, hospitalization).

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Study Start: 2017-10-17
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• The patient has been correctly informed
• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• French speaking adults (18 years or older) freely hospitalized (in centres or via emergency services) for prevention of suicide and who have a medium or high suicide risk score according to a Mini International Neuropsychiatric Interview structured interview
• Presence of suicidal ideation according to the Beck Suicide Ideation Scale (score > 3)
• Prior (or recent) suicide attempt within the last three month
• The patient is able to understand the study and capable of giving his/her informed consent
• The patient is available during the weekly time slots proposed by the investigator

Exclusion Criteria

• The patient is participating in another study that may interfere with the results or conclusions of this study
• Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, or is an adult under guardianship
• The patient refuses to sign the consent, or it is impossible to correctly inform the patient
• Emergency situations preventing proper study conduct
• History of schizophrenia or other psychotic troubles
• Presence of psychotic symptoms at initial interview
• Serious cognitive impairment
• Medical incapacity to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period	12 months

Secondary Outcome Measures

Name	Time	Method
The Columbia suicide severity rating scale (C-SSRS)	12 months
Number of suicide re-attempts during the follow-up period.	12 months	A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Beck Suicide Ideation Scale (BSSI)	12 months
Beck Hopelessness Scale (BHS)	12 months
Cumulative days of hospitalization	12 months
Completed suicide (yes/no)	12 months
Beck Depression Inventory-II (BDI-II)	12 months

Trial Locations

Locations (18)

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied; 🇫🇷 Clermont Ferrand, France

CHU de Lyon - Groupement Hospitalier Edouard Herriot; 🇫🇷 Lyon Cedex 3, France

CHRU de Montpellier - Hôpital Lapeyronie; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France

Clinique Les Sophoras; 🇫🇷 Nîmes, France

CMME; 🇫🇷 Paris, France

CH Henri Laborit; 🇫🇷 Poitiers, France

CHRU de Tours - Clinique Psychiatrique Universitaire; 🇫🇷 Saint Cyr sur Loire, France

CHRU de Strasbourg - Hôpital Civil; 🇫🇷 Strasbourg Cedex, France

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied; 🇫🇷 Clermont Ferrand, France

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