Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts
- Conditions
- Suicide, AttemptSuicidal Ideation
- Interventions
- Other: Baseline evaluation with a psychiatristOther: Individual supportive therapyOther: Cognitive behavioural group therapyOther: Evaluations with a psychiatrist
- Registration Number
- NCT02664701
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individual supportive therapy 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 Cognitive behavioural group therapy 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 Individual supportive therapy Baseline evaluation with a psychiatrist 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 Cognitive behavioural group therapy 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 Individual supportive therapy Evaluations with a psychiatrist 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 Cognitive behavioural group therapy Baseline evaluation 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
- Primary Outcome Measures
Name Time Method The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period 12 months
- Secondary Outcome Measures
Name Time Method The Columbia suicide severity rating scale (C-SSRS) 12 months Number of suicide re-attempts during the follow-up period. 12 months A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.
Completed suicide (yes/no) 12 months Beck Suicide Ideation Scale (BSSI) 12 months Beck Hopelessness Scale (BHS) 12 months Cumulative days of hospitalization 12 months Beck Depression Inventory-II (BDI-II) 12 months
Trial Locations
- Locations (9)
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
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
CMME
🇫🇷Paris, France
CH Henri Laborit
🇫🇷Poitiers, France
CHRU de Strasbourg - Hôpital Civil
🇫🇷Strasbourg Cedex, France
Clinique Les Sophoras
🇫🇷Nîmes, France
CHRU de Tours - Clinique Psychiatrique Universitaire
🇫🇷Saint Cyr sur Loire, France