Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts (G-PACTS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide, Attempt
• Intervention / Treatment: Other: Baseline evaluation with a psychiatrist; Other: Individual supportive therapy; Other: Evaluations with a psychiatrist; Other: Cognitive behavioural group therapy

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mocrane Abbar, MD; Phone Number: +33.(0)4.66.68.34.26; Email: mocrane.abbar@chu-nimes.fr
• Study Contact Backup: Name: Carey Suehs, PhD; Phone Number: +33.(0)4.66.68.67.88; Email: carey.suehs@chu-nimes.fr

Study Locations

• France
  • Clermont Ferrand, France, 63003
    • Not yet recruiting
    • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
    • Principal Investigator: Pierre-Michel Llorca, MD, PhD
  • Lyon Cedex 3, France, 69437
    • Not yet recruiting
    • CHU de Lyon - Groupement Hospitalier Edouard Herriot
    • Principal Investigator: Emmanuel Poulet, MD, PhD
  • Montpellier, France, 34295
    • Not yet recruiting
    • CHRU de Montpellier - Hôpital Lapeyronie
    • Principal Investigator: Philippe Courtet, MD, PhD
  • Nîmes, France, 30000
    • Not yet recruiting
    • Clinique Les Sophoras
    • Principal Investigator: Stephane Torrès, MD
  • Nîmes Cedex 09, France, 30029
    • Recruiting
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
    • Sub-Investigator: Mocrane Abbar, MD
    • Principal Investigator: Jorge Lopez Castroman, MD
    • Sub-Investigator: Laurent Chaïb, PhD, pschologist
  • Paris, France, 75674
    • Recruiting
    • CMME
    • Contact: FABRICE JOLLANT; Phone Number: 0145658572; Email: fjolllant@gmail.com
  • Poitiers, France, 86021
    • Not yet recruiting
    • CH Henri Laborit
    • Principal Investigator: Nematollah Jaafari, MD
  • Saint Cyr sur Loire, France, 37540
    • Not yet recruiting
    • CHRU de Tours - Clinique Psychiatrique Universitaire
    • Principal Investigator: Wissam El-Hage, MD
  • Strasbourg Cedex, France, 67091
    • Not yet recruiting
    • CHRU de Strasbourg - Hôpital Civil
    • Principal Investigator: Pierre Vidailhet, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Individual supportive therapy; 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 psychiatrist; Baseline data and questionnaires are established.; Other: Individual supportive therapy; 6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks; Other: 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.
Experimental: Cognitive behavioural group therapy; 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 psychiatrist; Baseline data and questionnaires are established.; Other: 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.; Other: Cognitive behavioural group therapy; 6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The Columbia suicide severity rating scale (C-SSRS)		12 months
Completed suicide (yes/no)		in the 10 days after the end of psychotherapy
Completed suicide (yes/no)		3 months
Completed suicide (yes/no)		6 months
Completed suicide (yes/no)		9 months
Completed suicide (yes/no)		12 months
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
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
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
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
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
Beck Suicide Ideation Scale (BSSI)		Baseline
Beck Suicide Ideation Scale (BSSI)		in the 10 days after the end of psychotherapy
Beck Suicide Ideation Scale (BSSI)		3 months
Beck Suicide Ideation Scale (BSSI)		6 months
Beck Suicide Ideation Scale (BSSI)		9 months
Beck Suicide Ideation Scale (BSSI)		12 months
Beck Depression Inventory-II (BDI-II)		Baseline
Beck Depression Inventory-II (BDI-II)		in the 10 days after the end of psychotherapy
Beck Depression Inventory-II (BDI-II)		3 months
Beck Depression Inventory-II (BDI-II)		6 months
Beck Depression Inventory-II (BDI-II)		9 months
Beck Depression Inventory-II (BDI-II)		12 months
Beck Hopelessness Scale (BHS)		Baseline
Beck Hopelessness Scale (BHS)		in the 10 days after the end of psychotherapy
Beck Hopelessness Scale (BHS)		3 months
Beck Hopelessness Scale (BHS)		6 months
Beck Hopelessness Scale (BHS)		9 months
Beck Hopelessness Scale (BHS)		12 months
Cumulative days of hospitalization		in the 10 days after the end of psychotherapy
Cumulative days of hospitalization		3 months
Cumulative days of hospitalization		6 months
Cumulative days of hospitalization		9 months
Cumulative days of hospitalization		12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Mocrane Abbar, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimated): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: PHRC-N/2014/MA-01; 2015-A01585-44 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No