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

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ClinicalTrials.gov Identifier: NCT02664701
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 17, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




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

Secondary Outcome Measures :
  1. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: baseline ]
  2. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: in the 10 days after the end of psychotherapy ]
  3. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: 3 months ]
  4. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: 6 months ]
  5. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: 9 months ]
  6. The Columbia suicide severity rating scale (C-SSRS) [ Time Frame: 12 months ]
  7. Completed suicide (yes/no) [ Time Frame: in the 10 days after the end of psychotherapy ]
  8. Completed suicide (yes/no) [ Time Frame: 3 months ]
  9. Completed suicide (yes/no) [ Time Frame: 6 months ]
  10. Completed suicide (yes/no) [ Time Frame: 9 months ]
  11. Completed suicide (yes/no) [ Time Frame: 12 months ]
  12. Number of suicide re-attempts during the follow-up period. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: Baseline ]
  18. Beck Suicide Ideation Scale (BSSI) [ Time Frame: in the 10 days after the end of psychotherapy ]
  19. Beck Suicide Ideation Scale (BSSI) [ Time Frame: 3 months ]
  20. Beck Suicide Ideation Scale (BSSI) [ Time Frame: 6 months ]
  21. Beck Suicide Ideation Scale (BSSI) [ Time Frame: 9 months ]
  22. Beck Suicide Ideation Scale (BSSI) [ Time Frame: 12 months ]
  23. Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline ]
  24. Beck Depression Inventory-II (BDI-II) [ Time Frame: in the 10 days after the end of psychotherapy ]
  25. Beck Depression Inventory-II (BDI-II) [ Time Frame: 3 months ]
  26. Beck Depression Inventory-II (BDI-II) [ Time Frame: 6 months ]
  27. Beck Depression Inventory-II (BDI-II) [ Time Frame: 9 months ]
  28. Beck Depression Inventory-II (BDI-II) [ Time Frame: 12 months ]
  29. Beck Hopelessness Scale (BHS) [ Time Frame: Baseline ]
  30. Beck Hopelessness Scale (BHS) [ Time Frame: in the 10 days after the end of psychotherapy ]
  31. Beck Hopelessness Scale (BHS) [ Time Frame: 3 months ]
  32. Beck Hopelessness Scale (BHS) [ Time Frame: 6 months ]
  33. Beck Hopelessness Scale (BHS) [ Time Frame: 9 months ]
  34. Beck Hopelessness Scale (BHS) [ Time Frame: 12 months ]
  35. Cumulative days of hospitalization [ Time Frame: in the 10 days after the end of psychotherapy ]
  36. Cumulative days of hospitalization [ Time Frame: 3 months ]
  37. Cumulative days of hospitalization [ Time Frame: 6 months ]
  38. Cumulative days of hospitalization [ Time Frame: 9 months ]
  39. Cumulative days of hospitalization [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664701


Contacts
Contact: Mocrane Abbar, MD +33.(0)4.66.68.34.26 mocrane.abbar@chu-nimes.fr
Contact: Carey Suehs, Phd +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied Not yet recruiting
Clermont Ferrand, France, 63003
Principal Investigator: Pierre-Michel Llorca, MD, PhD         
CHU de Lyon - Groupement Hospitalier Edouard Herriot Not yet recruiting
Lyon Cedex 3, France, 69437
Principal Investigator: Emmanuel Poulet, MD, PhD         
CHRU de Montpellier - Hôpital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Principal Investigator: Philippe Courtet, MD, PhD         
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Sub-Investigator: Mocrane Abbar, MD         
Principal Investigator: Jorge Lopez Castroman, MD         
Sub-Investigator: Laurent Chaïb, PhD, pschologist         
Clinique Les Sophoras Not yet recruiting
Nîmes, France, 30000
Principal Investigator: Stephane Torrès, MD         
CH Henri Laborit Not yet recruiting
Poitiers, France, 86021
Principal Investigator: Nematollah Jaafari, MD         
CHRU de Tours - Clinique Psychiatrique Universitaire Not yet recruiting
Saint Cyr sur Loire, France, 37540
Principal Investigator: Wissam El-Hage, MD         
CHRU de Strasbourg - Hôpital Civil Not yet recruiting
Strasbourg Cedex, France, 67091
Principal Investigator: Pierre Vidailhet, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Mocrane Abbar, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02664701     History of Changes
Other Study ID Numbers: PHRC-N/2014/MA-01
2015-A01585-44 ( Other Identifier: RCB number )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

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
Self-Injurious Behavior
Behavioral Symptoms