Suicidal Ideation, Suicide, Attempt
Conditions
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).
Interventions
OTHERBaseline evaluation with a psychiatrist
Baseline data and questionnaires are established.
OTHERIndividual supportive therapy
6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks
6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks
OTHEREvaluations with a psychiatrist
Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completed suicide (yes/no) | in the 10 days after the end of psychotherapy | — |
| Number of suicide re-attempts during the follow-up period. | in the 10 days after the end of psychotherapy | 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) | Baseline | — |
| The Columbia suicide severity rating scale (C-SSRS) | baseline | — |
| Beck Hopelessness Scale (BHS) | Baseline | — |
| Cumulative days of hospitalization | in the 10 days after the end of psychotherapy | — |
| Beck Depression Inventory-II (BDI-II) | Baseline | — |
Countries
France
Outcome results
None listed