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Suicidal IdeationG-PACTSNCT02664701

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

A study testing Baseline evaluation with a psychiatrist, Individual supportive therapy and Cognitive behavioural group therapy in people with Suicidal Ideation and Suicide, Attempt, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicidal Ideation, Suicide, Attempt
What is being tested?
Baseline evaluation with a psychiatrist, Individual supportive therapy and Cognitive behavioural group therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
9 sitesFrance
Study dates
17 Oct 2017to Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • History of schizophrenia or other psychotic troubles
  • Presence of psychotic symptoms at initial interview
  • Serious cognitive impairment
  • Medical incapacity to participate

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

    Clermont-Ferrand, 63003

  • CHU de Lyon - Groupement Hospitalier Edouard Herriot

    Lyon, 69437

  • CHRU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • Clinique Les Sophoras

    Nîmes, 30000

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CMME

    Paris, 75674

  • CH Henri Laborit

    Poitiers, 86021

  • CHRU de Tours - Clinique Psychiatrique Universitaire

    Saint-Cyr-sur-Loire, 37540

  • CHRU de Strasbourg - Hôpital Civil

    Strasbourg, 67091

Other trials in France

About this study

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

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.

Read the 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).
Being tested
Baseline evaluation with a psychiatrist, Individual supportive therapy, Cognitive behavioural group therapy, Evaluations with a psychiatrist
Medical subject headings
Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline evaluation with a psychiatristOther

    Baseline data and questionnaires are established.

  • Individual supportive therapyOther

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

  • Cognitive behavioural group therapyOther

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

  • Evaluations with a psychiatristOther

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

Study groups in NCT02664701
Study groupRoleWhat they receive
Individual supportive therapyActive comparatorPatients randomized to this arm will have individual supportive therapy. Intervention: Baseline evaluation with a psychiatrist Intervention: Individual supportive therapy Intervention: Evaluations with a psychiatrist
Receives: Other: Baseline evaluation with a psychiatrist; Other: Individual supportive therapy; Other: Evaluations with a psychiatrist
Cognitive behavioural group therapyExperimentalPatients 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
Receives: Other: Baseline evaluation with a psychiatrist; Other: Cognitive behavioural group therapy; Other: Evaluations with a psychiatrist

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

Secondary outcomes (39)

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

    Measured: baseline

  2. The Columbia suicide severity rating scale (C-SSRS)

    Measured: in the 10 days after the end of psychotherapy

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

    Measured: 3 months

  4. The Columbia suicide severity rating scale (C-SSRS)

    Measured: 6 months

  5. The Columbia suicide severity rating scale (C-SSRS)

    Measured: 9 months

  6. The Columbia suicide severity rating scale (C-SSRS)

    Measured: 12 months

  7. Completed suicide (yes/no)

    Measured: in the 10 days after the end of psychotherapy

  8. Completed suicide (yes/no)

    Measured: 3 months

  9. Completed suicide (yes/no)

    Measured: 6 months

  10. Completed suicide (yes/no)

    Measured: 9 months

  11. Completed suicide (yes/no)

    Measured: 12 months

  12. Number of suicide re-attempts during the follow-up period.

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

    Measured: in the 10 days after the end of psychotherapy

  13. Number of suicide re-attempts during the follow-up period.

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

    Measured: 3 months

  14. Number of suicide re-attempts during the follow-up period.

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

    Measured: 6 months

  15. Number of suicide re-attempts during the follow-up period.

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

    Measured: 9 months

  16. Number of suicide re-attempts during the follow-up period.

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

    Measured: 12 months

  17. Beck Suicide Ideation Scale (BSSI)

    Measured: Baseline

  18. Beck Suicide Ideation Scale (BSSI)

    Measured: in the 10 days after the end of psychotherapy

  19. Beck Suicide Ideation Scale (BSSI)

    Measured: 3 months

  20. Beck Suicide Ideation Scale (BSSI)

    Measured: 6 months

  21. Beck Suicide Ideation Scale (BSSI)

    Measured: 9 months

  22. Beck Suicide Ideation Scale (BSSI)

    Measured: 12 months

  23. Beck Depression Inventory-II (BDI-II)

    Measured: Baseline

  24. Beck Depression Inventory-II (BDI-II)

    Measured: in the 10 days after the end of psychotherapy

  25. Beck Depression Inventory-II (BDI-II)

    Measured: 3 months

  26. Beck Depression Inventory-II (BDI-II)

    Measured: 6 months

  27. Beck Depression Inventory-II (BDI-II)

    Measured: 9 months

  28. Beck Depression Inventory-II (BDI-II)

    Measured: 12 months

  29. Beck Hopelessness Scale (BHS)

    Measured: Baseline

  30. Beck Hopelessness Scale (BHS)

    Measured: in the 10 days after the end of psychotherapy

  31. Beck Hopelessness Scale (BHS)

    Measured: 3 months

  32. Beck Hopelessness Scale (BHS)

    Measured: 6 months

  33. Beck Hopelessness Scale (BHS)

    Measured: 9 months

  34. Beck Hopelessness Scale (BHS)

    Measured: 12 months

  35. Cumulative days of hospitalization

    Measured: in the 10 days after the end of psychotherapy

  36. Cumulative days of hospitalization

    Measured: 3 months

  37. Cumulative days of hospitalization

    Measured: 6 months

  38. Cumulative days of hospitalization

    Measured: 9 months

  39. Cumulative days of hospitalization

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2016 (estimated)
  2. Study start17 Oct 2017
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664701
Sponsor's protocol ID
PHRC-N/2014/MA-01
Other IDs
2015-A01585-44
Acronym
G-PACTS
Status last verified
Aug 2025
First submitted
19 Jan 2016
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PubMed 33884617

  • Chaib LS, Lopez-Castroman J, Abbar M. Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial. Trials. 2020 Oct 27;21(1):889. doi: 10.1186/s13063-020-04816-y.

    PubMed 33109271

Questions about this trial

What is this clinical trial studying?

A study testing Baseline evaluation with a psychiatrist, Individual supportive therapy and Cognitive behavioural group therapy in people with Suicidal Ideation and Suicide, Attempt, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary clinical endpoint is the duration (in days) of a suicide reattempt-free follow-up period (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664701, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.

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