NCT02664701
Active, Not Recruiting
N/A
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
Centre Hospitalier Universitaire de Nīmes18 sites in 1 country240 target enrollmentOctober 17, 2017
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Suicidal Ideation
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 240
- Locations
- 18
- Primary Endpoint
- The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
- Status
- Active, Not Recruiting
- Last Updated
- 8 months ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period
Time Frame: 12 months
Secondary Outcomes
- The Columbia suicide severity rating scale (C-SSRS)(12 months)
- Number of suicide re-attempts during the follow-up period.(12 months)
- Completed suicide (yes/no)(12 months)
- Beck Suicide Ideation Scale (BSSI)(12 months)
- Beck Depression Inventory-II (BDI-II)(12 months)
- Beck Hopelessness Scale (BHS)(12 months)
- Cumulative days of hospitalization(12 months)
Study Sites (18)
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