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

Primary Purpose

Suicidal Ideation, Suicide, Attempt

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Baseline evaluation with a psychiatrist
Individual supportive therapy
Cognitive behavioural group therapy
Evaluations with a psychiatrist
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
  • CHU de Lyon - Groupement Hospitalier Edouard Herriot
  • CHRU de Montpellier - Hôpital Lapeyronie
  • CHRU de Nîmes - Hôpital Universitaire CarémeauRecruiting
  • Clinique Les Sophoras
  • CMMERecruiting
  • CH Henri Laborit
  • CHRU de Tours - Clinique Psychiatrique Universitaire
  • CHRU de Strasbourg - Hôpital Civil

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Individual supportive therapy

Cognitive behavioural group therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Columbia suicide severity rating scale (C-SSRS)
The Columbia suicide severity rating scale (C-SSRS)
The Columbia suicide severity rating scale (C-SSRS)
The Columbia suicide severity rating scale (C-SSRS)
The Columbia suicide severity rating scale (C-SSRS)
The Columbia suicide severity rating scale (C-SSRS)
Completed suicide (yes/no)
Completed suicide (yes/no)
Completed suicide (yes/no)
Completed suicide (yes/no)
Completed suicide (yes/no)
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.
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.
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.
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.
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.
Beck Suicide Ideation Scale (BSSI)
Beck Suicide Ideation Scale (BSSI)
Beck Suicide Ideation Scale (BSSI)
Beck Suicide Ideation Scale (BSSI)
Beck Suicide Ideation Scale (BSSI)
Beck Suicide Ideation Scale (BSSI)
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II)
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS)
Cumulative days of hospitalization
Cumulative days of hospitalization
Cumulative days of hospitalization
Cumulative days of hospitalization
Cumulative days of hospitalization

Full Information

First Posted
January 19, 2016
Last Updated
September 7, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02664701
Brief Title
Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Attempt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individual supportive therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Cognitive behavioural group therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Baseline evaluation with a psychiatrist
Intervention Description
Baseline data and questionnaires are established.
Intervention Type
Other
Intervention Name(s)
Individual supportive therapy
Intervention Description
6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Cognitive behavioural group therapy
Intervention Description
6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks
Intervention Type
Other
Intervention Name(s)
Evaluations with a psychiatrist
Intervention Description
Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.
Primary Outcome Measure Information:
Title
The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
baseline
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
in the 10 days after the end of psychotherapy
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
3 months
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
6 months
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
9 months
Title
The Columbia suicide severity rating scale (C-SSRS)
Time Frame
12 months
Title
Completed suicide (yes/no)
Time Frame
in the 10 days after the end of psychotherapy
Title
Completed suicide (yes/no)
Time Frame
3 months
Title
Completed suicide (yes/no)
Time Frame
6 months
Title
Completed suicide (yes/no)
Time Frame
9 months
Title
Completed suicide (yes/no)
Time Frame
12 months
Title
Number of suicide re-attempts during the follow-up period.
Description
A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Time Frame
in the 10 days after the end of psychotherapy
Title
Number of suicide re-attempts during the follow-up period.
Description
A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Time Frame
3 months
Title
Number of suicide re-attempts during the follow-up period.
Description
A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Time Frame
6 months
Title
Number of suicide re-attempts during the follow-up period.
Description
A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Time Frame
9 months
Title
Number of suicide re-attempts during the follow-up period.
Description
A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Time Frame
12 months
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
Baseline
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
in the 10 days after the end of psychotherapy
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
3 months
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
6 months
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
9 months
Title
Beck Suicide Ideation Scale (BSSI)
Time Frame
12 months
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
Baseline
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
in the 10 days after the end of psychotherapy
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
3 months
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
6 months
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
9 months
Title
Beck Depression Inventory-II (BDI-II)
Time Frame
12 months
Title
Beck Hopelessness Scale (BHS)
Time Frame
Baseline
Title
Beck Hopelessness Scale (BHS)
Time Frame
in the 10 days after the end of psychotherapy
Title
Beck Hopelessness Scale (BHS)
Time Frame
3 months
Title
Beck Hopelessness Scale (BHS)
Time Frame
6 months
Title
Beck Hopelessness Scale (BHS)
Time Frame
9 months
Title
Beck Hopelessness Scale (BHS)
Time Frame
12 months
Title
Cumulative days of hospitalization
Time Frame
in the 10 days after the end of psychotherapy
Title
Cumulative days of hospitalization
Time Frame
3 months
Title
Cumulative days of hospitalization
Time Frame
6 months
Title
Cumulative days of hospitalization
Time Frame
9 months
Title
Cumulative days of hospitalization
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mocrane Abbar, MD
Phone
+33.(0)4.66.68.34.26
Email
mocrane.abbar@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carey Suehs, Phd
Phone
+33.(0)4.66.68.67.88
Email
carey.suehs@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mocrane Abbar, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Michel Llorca, MD, PhD
Facility Name
CHU de Lyon - Groupement Hospitalier Edouard Herriot
City
Lyon Cedex 3
ZIP/Postal Code
69437
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Poulet, MD, PhD
Facility Name
CHRU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Courtet, MD, PhD
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mocrane Abbar, MD
First Name & Middle Initial & Last Name & Degree
Jorge Lopez Castroman, MD
First Name & Middle Initial & Last Name & Degree
Laurent Chaïb, PhD, pschologist
Facility Name
Clinique Les Sophoras
City
Nîmes
ZIP/Postal Code
30000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Torrès, MD
Facility Name
CMME
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FABRICE JOLLANT
Phone
0145658572
Email
fjolllant@gmail.com
Facility Name
CH Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nematollah Jaafari, MD
Facility Name
CHRU de Tours - Clinique Psychiatrique Universitaire
City
Saint Cyr sur Loire
ZIP/Postal Code
37540
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wissam El-Hage, MD
Facility Name
CHRU de Strasbourg - Hôpital Civil
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Vidailhet, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
33109271
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.
Results Reference
derived

Learn more about this trial

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

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