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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Suicidal Ideation, Suicide, Attempt

Intervention / Treatment
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* Other: Baseline evaluation with a psychiatrist
* Other: Individual supportive therapy
* Other: Cognitive behavioural group therapy
* Other: Evaluations with a psychiatrist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual supportive therapy<br>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<br>* Baseline data and questionnaires are established.<br>Other: Individual supportive therapy<br>* 6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks<br>Other: Evaluations with a psychiatrist<br>* Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.<br>|
| Experimental: Cognitive behavioural group therapy<br>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<br>* Baseline data and questionnaires are established.<br>Other: Cognitive behavioural group therapy<br>* 6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks<br>Other: Evaluations with a psychiatrist<br>* Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |