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

Suicidal Ideation Clinical Trial

— G-PACTS  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempt
• Suicide, Attempted

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