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Active, Not Recruiting

NCT Number: NCT02664701

Cognitive Behavioural Group Therapy Versus Individual Supportive Therapy for the Prevention of Repeat Suicide Attempts

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline evaluation with a psychiatrist

Other

Baseline data and questionnaires are established.

Individual supportive therapy

Other

6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks

Cognitive behavioural group therapy

Other

6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks

Evaluations with a psychiatrist

Other

Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: G-PACTS

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2016
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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