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Completed

NCT Number: NCT02936700

Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior

Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.

The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.

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Key information

Conditions

Actual Suicidal Behavior Disorder Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier Hospital University

Montpellier, 34295, France

About this study

42 patients having a history of suicide attempt within the year preceding inclusion have been recruited.

First visit or inclusion (within 2 weeks preceding the beginning of the program): clinical, biological assessment and fMRI acquisition Second visit (within 2 weeks +/- 1 week following completion of the program): clinical assessment and fMRI acquisition Third visit (within 3 months +/- 2 weeks following completion of the program): clinical assessment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 18 and 65 years
  • Having signed informed consent
  • Main diagnosis of major depressive episode (DSM-5 criteria)
  • History of suicide attempt within the year
  • Able to understand nature, aims, methodology of the study and agree to cooperate in clinical, radiological assessments.

Exclusion criteria

  • Current diagnosis of substance abuse or dependence in the last 6 months (including tobacco and alcohol)
  • Current lifetime diagnosis of schizophrenia, or schizoaffective disorder
  • Current diagnosis of manic, hypomanic according to DSM-5 criteria
  • Contraindications for the use of MRI, : metallic artificial heart valve, pacemaker, ferromagnetic cerebrovascular clips, metallic foreign body including brain mobilized or intraocular ferromagnetic prosthesis impossibility of absolute immobility, claustrophobia.
  • Lifetime history of traumatic brain injury with loss of consciousness
  • Pregnancy
  • Patient on protective measures (guardianship or trusteeship)
  • Patient for which the maximum annual amount of allowances 4 500 euros has been reached

Treatment and study plan

Relaxation

Behavioral

relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.

ACT therapy

Behavioral

7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at

  • decreasing the tendency to try to escape unpleasant mental experiences
  • increasing psychological flexibility
  • developing acceptance of psychological events and engagement in valued actions

Primary outcomes

  1. Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task

    Time frame: At 2 weeks after group completion

    Comparison between inclusion and 2 weeks after group completion of cerebral activation within ACT group

  2. Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task

    Time frame: At 2 weeks after group completion

    Comparison between inclusion and 2 weeks after group completion of cerebral activation within relaxation group

  3. Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task

    Time frame: At 3 months after therapy

    comparison between subjects with suicidal ideation vs. without suicidal ideation at 3 months after therapy

Secondary outcomes

  1. Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task

    Time frame: At the inclusion, and 2 weeks after the end of the therapy

    comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation

  2. Activation of specific brain regions during Cyberball game, a validated exclusion task

    Time frame: At the inclusion, and 2 weeks after the end of the therapy

    comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation

  3. Activation of specific brain regions during a motivational task

    Time frame: At the inclusion, and 2 weeks after the end of the therapy

    comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation

  4. Change of activation of default mode network (DMN) during resting state acquisition

    Time frame: Baseline acquisition and 2 weeks after therapy

    Comparison between groups

  5. Baseline activation of DMN during resting state acquisition

    Time frame: Baseline acquisition and clinical assessment at 3 months after therapy

    Comparison between subjects with suicidal ideation versus without at 3 months after therapy

  6. Baseline fraction of anisotropy

    Time frame: Baseline acquisition and clinical assessment at 3 months

    Comparison between subjects with suicidal ideation versus without at 3 months after therapy

  7. Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS)

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups

  8. Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30)

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups

  9. Evolution of psychologic pain during the follow up

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups by Likert scale

  10. Evolution of anger during the follow up.

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups by the STAXI scale (Spielberger State-Trait Anger Expression Inventory)

  11. Evolution of clinical global impression during the follow up.

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups by the CGI (Clinical Global Impressions scale)

  12. Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI)

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups

  13. Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS)

    Time frame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

    Comparison between the beginning and the end within each group and comparison between the two groups

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder

Acronym: IMPACT

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 18, 2016
Registry last updated
Jul 7, 2023

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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