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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02664701
• Collaborator: (none)
• Enrollment: 240
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 89.5
• Patients Per Site: 26.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation; Suicide, Attempt	Other: Baseline evaluation with a psychiatrist; Other: Individual supportive therapy; Other: Cognitive behavioural group therapy; Other: Evaluations with a psychiatrist	N/A

Detailed Description

The secondary objectives of this study are to assess the efficacy of CBGT on:

1. parameters describing the incidence of suicide and repeat suicide attempts, as well as suicide re-attempt free follow-up time,

2. long-term changes in suicidal ideation,

3. long-term changes in psychiatric symptoms (depression, hope for the future, hospitalization).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 17, 2017
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period [12 months]

Secondary Outcome Measures

1. The Columbia suicide severity rating scale (C-SSRS) [baseline]

2. The Columbia suicide severity rating scale (C-SSRS) [in the 10 days after the end of psychotherapy]

3. The Columbia suicide severity rating scale (C-SSRS) [3 months]

4. The Columbia suicide severity rating scale (C-SSRS) [6 months]

5. The Columbia suicide severity rating scale (C-SSRS) [9 months]

6. The Columbia suicide severity rating scale (C-SSRS) [12 months]

7. Completed suicide (yes/no) [in the 10 days after the end of psychotherapy]

8. Completed suicide (yes/no) [3 months]

9. Completed suicide (yes/no) [6 months]

10. Completed suicide (yes/no) [9 months]

11. Completed suicide (yes/no) [12 months]

12. 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.

13. Number of suicide re-attempts during the follow-up period. [3 months]

    A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.

14. Number of suicide re-attempts during the follow-up period. [6 months]

    A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.

15. Number of suicide re-attempts during the follow-up period. [9 months]

    A suicide attempt is defined as either an "actual attempt" or an "interrupted attempt" using the definitions in the C-SSRS assessment.

16. 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.

17. Beck Suicide Ideation Scale (BSSI) [Baseline]

18. Beck Suicide Ideation Scale (BSSI) [in the 10 days after the end of psychotherapy]

19. Beck Suicide Ideation Scale (BSSI) [3 months]

20. Beck Suicide Ideation Scale (BSSI) [6 months]

21. Beck Suicide Ideation Scale (BSSI) [9 months]

22. Beck Suicide Ideation Scale (BSSI) [12 months]

23. Beck Depression Inventory-II (BDI-II) [Baseline]

24. Beck Depression Inventory-II (BDI-II) [in the 10 days after the end of psychotherapy]

25. Beck Depression Inventory-II (BDI-II) [3 months]

26. Beck Depression Inventory-II (BDI-II) [6 months]

27. Beck Depression Inventory-II (BDI-II) [9 months]

28. Beck Depression Inventory-II (BDI-II) [12 months]

29. Beck Hopelessness Scale (BHS) [Baseline]

30. Beck Hopelessness Scale (BHS) [in the 10 days after the end of psychotherapy]

31. Beck Hopelessness Scale (BHS) [3 months]

32. Beck Hopelessness Scale (BHS) [6 months]

33. Beck Hopelessness Scale (BHS) [9 months]

34. Beck Hopelessness Scale (BHS) [12 months]

35. Cumulative days of hospitalization [in the 10 days after the end of psychotherapy]

36. Cumulative days of hospitalization [3 months]

37. Cumulative days of hospitalization [6 months]

38. Cumulative days of hospitalization [9 months]

39. Cumulative days of hospitalization [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont Ferrand - Hôpital Gabriel-Montpied	Clermont Ferrand		France	63003
2	CHU de Lyon - Groupement Hospitalier Edouard Herriot	Lyon Cedex 3		France	69437
3	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier		France	34295
4	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09		France	30029
5	Clinique Les Sophoras	Nîmes		France	30000
6	CMME	Paris		France	75674
7	CH Henri Laborit	Poitiers		France	86021
8	CHRU de Tours - Clinique Psychiatrique Universitaire	Saint Cyr sur Loire		France	37540
9	CHRU de Strasbourg - Hôpital Civil	Strasbourg Cedex		France	67091

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Study Director: Mocrane Abbar, MD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT02664701
• Other Study ID Numbers: PHRC-N/2014/MA-01; 2015-A01585-44
• First Posted: Jan 27, 2016
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted

Study Results

No Results Posted as of Jan 27, 2022