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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02664701
Other study ID # PHRC-N/2014/MA-01
Secondary ID 2015-A01585-44
Status Recruiting
Phase N/A
First received
Last updated
Start date October 17, 2017
Est. completion date April 2025

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire de Nimes
Contact Mocrane Abbar, MD
Phone +33.(0)4.66.68.34.26
Email mocrane.abbar@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date April 2025
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Baseline evaluation with a psychiatrist
Baseline data and questionnaires are established.
Individual supportive therapy
6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks
Cognitive behavioural group therapy
6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks
Evaluations with a psychiatrist
Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.

Locations

Country Name City State
France 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 Clinique Les Sophoras Nîmes
France CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09
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

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period 12 months
Secondary The Columbia suicide severity rating scale (C-SSRS) baseline
Secondary The Columbia suicide severity rating scale (C-SSRS) in the 10 days after the end of psychotherapy
Secondary The Columbia suicide severity rating scale (C-SSRS) 3 months
Secondary The Columbia suicide severity rating scale (C-SSRS) 6 months
Secondary The Columbia suicide severity rating scale (C-SSRS) 9 months
Secondary The Columbia suicide severity rating scale (C-SSRS) 12 months
Secondary Completed suicide (yes/no) in the 10 days after the end of psychotherapy
Secondary Completed suicide (yes/no) 3 months
Secondary Completed suicide (yes/no) 6 months
Secondary Completed suicide (yes/no) 9 months
Secondary Completed suicide (yes/no) 12 months
Secondary Number of suicide re-attempts during the follow-up period. A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment. in the 10 days after the end of psychotherapy
Secondary Number of suicide re-attempts during the follow-up period. A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment. 3 months
Secondary Number of suicide re-attempts during the follow-up period. A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment. 6 months
Secondary Number of suicide re-attempts during the follow-up period. A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment. 9 months
Secondary Number of suicide re-attempts during the follow-up period. A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment. 12 months
Secondary Beck Suicide Ideation Scale (BSSI) Baseline
Secondary Beck Suicide Ideation Scale (BSSI) in the 10 days after the end of psychotherapy
Secondary Beck Suicide Ideation Scale (BSSI) 3 months
Secondary Beck Suicide Ideation Scale (BSSI) 6 months
Secondary Beck Suicide Ideation Scale (BSSI) 9 months
Secondary Beck Suicide Ideation Scale (BSSI) 12 months
Secondary Beck Depression Inventory-II (BDI-II) Baseline
Secondary Beck Depression Inventory-II (BDI-II) in the 10 days after the end of psychotherapy
Secondary Beck Depression Inventory-II (BDI-II) 3 months
Secondary Beck Depression Inventory-II (BDI-II) 6 months
Secondary Beck Depression Inventory-II (BDI-II) 9 months
Secondary Beck Depression Inventory-II (BDI-II) 12 months
Secondary Beck Hopelessness Scale (BHS) Baseline
Secondary Beck Hopelessness Scale (BHS) in the 10 days after the end of psychotherapy
Secondary Beck Hopelessness Scale (BHS) 3 months
Secondary Beck Hopelessness Scale (BHS) 6 months
Secondary Beck Hopelessness Scale (BHS) 9 months
Secondary Beck Hopelessness Scale (BHS) 12 months
Secondary Cumulative days of hospitalization in the 10 days after the end of psychotherapy
Secondary Cumulative days of hospitalization 3 months
Secondary Cumulative days of hospitalization 6 months
Secondary Cumulative days of hospitalization 9 months
Secondary Cumulative days of hospitalization 12 months
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