Clinical trial NCT02664701: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts
Official title: Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts: a Multicentre, Assessor-blinded, 2-parallel-group, Randomised, Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempt
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
timeFrame: 12 months
Secondary outcomes:
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: baseline
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: in the 10 days after the end of psychotherapy
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: 3 months
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: 6 months
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: 9 months
measure: The Columbia suicide severity rating scale (C-SSRS)
timeFrame: 12 months
measure: Completed suicide (yes/no)
timeFrame: in the 10 days after the end of psychotherapy
measure: Completed suicide (yes/no)
timeFrame: 3 months
measure: Completed suicide (yes/no)
timeFrame: 6 months
measure: Completed suicide (yes/no)
timeFrame: 9 months
measure: Completed suicide (yes/no)
timeFrame: 12 months
measure: Number of suicide re-attempts during the follow-up period.
timeFrame: in the 10 days after the end of psychotherapy
measure: Number of suicide re-attempts during the follow-up period.
timeFrame: 3 months
measure: Number of suicide re-attempts during the follow-up period.
timeFrame: 6 months
measure: Number of suicide re-attempts during the follow-up period.
timeFrame: 9 months
measure: Number of suicide re-attempts during the follow-up period.
timeFrame: 12 months
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: Baseline
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: in the 10 days after the end of psychotherapy
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: 3 months
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: 6 months
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: 9 months
measure: Beck Suicide Ideation Scale (BSSI)
timeFrame: 12 months
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: in the 10 days after the end of psychotherapy
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 3 months
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 6 months
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 9 months
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 12 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: Baseline
measure: Beck Hopelessness Scale (BHS)
timeFrame: in the 10 days after the end of psychotherapy
measure: Beck Hopelessness Scale (BHS)
timeFrame: 3 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: 6 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: 9 months
measure: Beck Hopelessness Scale (BHS)
timeFrame: 12 months
measure: Cumulative days of hospitalization
timeFrame: in the 10 days after the end of psychotherapy
measure: Cumulative days of hospitalization
timeFrame: 3 months
measure: Cumulative days of hospitalization
timeFrame: 6 months
measure: Cumulative days of hospitalization
timeFrame: 9 months
measure: Cumulative days of hospitalization
timeFrame: 12 months
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
city: Lyon Cedex 3
country: France
facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Nîmes
country: France
facility: Clinique Les Sophoras
city: Paris
country: France
facility: CMME
city: Poitiers
country: France
facility: CH Henri Laborit
city: Saint Cyr sur Loire
country: France
facility: CHRU de Tours - Clinique Psychiatrique Universitaire
city: Strasbourg Cedex
country: France
facility: CHRU de Strasbourg - Hôpital Civil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Mocrane Abbar, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.