NCT02664701

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 17, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

8 years

First QC Date

January 19, 2016

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period

    12 months

Secondary Outcomes (39)

  • The Columbia suicide severity rating scale (C-SSRS)

    baseline

  • The Columbia suicide severity rating scale (C-SSRS)

    in the 10 days after the end of psychotherapy

  • The Columbia suicide severity rating scale (C-SSRS)

    3 months

  • The Columbia suicide severity rating scale (C-SSRS)

    6 months

  • The Columbia suicide severity rating scale (C-SSRS)

    9 months

  • +34 more secondary outcomes

Study Arms (2)

Individual supportive therapy

ACTIVE COMPARATOR

Patients randomized to this arm will have individual supportive therapy. Intervention: Baseline evaluation with a psychiatrist Intervention: Individual supportive therapy Intervention: Evaluations with a psychiatrist

Other: Baseline evaluation with a psychiatristOther: Individual supportive therapyOther: Evaluations with a psychiatrist

Cognitive behavioural group therapy

EXPERIMENTAL

Patients randomized to this arm will have cognitive behavioural therapy. Intervention: Baseline evaluation with a psychiatrist Intervention: Cognitive behavioural group therapy Intervention: Evaluations with a psychiatrist

Other: Baseline evaluation with a psychiatristOther: Cognitive behavioural group therapyOther: Evaluations with a psychiatrist

Interventions

Baseline data and questionnaires are established.

Cognitive behavioural group therapyIndividual supportive therapy

6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks

Individual supportive therapy

6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks

Cognitive behavioural group therapy

Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.

Cognitive behavioural group therapyIndividual supportive therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

CHU de Lyon - Groupement Hospitalier Edouard Herriot

Lyon, 69437, France

Location

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Clinique Les Sophoras

Nîmes, 30000, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CMME

Paris, 75674, France

Location

CH Henri Laborit

Poitiers, 86021, France

Location

CHRU de Tours - Clinique Psychiatrique Universitaire

Saint-Cyr-sur-Loire, 37540, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (2)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  • Chaib LS, Lopez-Castroman J, Abbar M. Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial. Trials. 2020 Oct 27;21(1):889. doi: 10.1186/s13063-020-04816-y.

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Mocrane Abbar, MD

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 27, 2016

Study Start

October 17, 2017

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations