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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Suicide, Attempt; Suicidal Ideation

Treatments: Other: Individual supportive therapy; Other: Evaluations with a psychiatrist; Other: Cognitive behavioural group therapy; Other: Baseline evaluation with a psychiatrist

Study type: Interventional

Funder types: Other

Identifiers

NCT02664701

PHRC-N/2014/MA-01

2015-A01585-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Individual supportive therapy

Active Comparator group

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

Treatment:

Other: Baseline evaluation with a psychiatrist

Other: Evaluations with a psychiatrist

Other: Individual supportive therapy

Cognitive behavioural group therapy

Experimental group

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

Treatment:

Other: Baseline evaluation with a psychiatrist

Other: Cognitive behavioural group therapy

Other: Evaluations with a psychiatrist