Actual Suicidal Behavior Disorder Clinical Trial
— IMPACTOfficial title:
Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
| Verified date | July 2023 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | March 5, 2017 |
| Est. primary completion date | September 5, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier Hospital University | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task | Comparison between inclusion and 2 weeks after group completion of cerebral activation within ACT group | At 2 weeks after group completion | |
| Primary | Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task | Comparison between inclusion and 2 weeks after group completion of cerebral activation within relaxation group | At 2 weeks after group completion | |
| Primary | Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task | comparison between subjects with suicidal ideation vs. without suicidal ideation at 3 months after therapy | At 3 months after therapy | |
| Secondary | Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task | comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation | At the inclusion, and 2 weeks after the end of the therapy | |
| Secondary | Activation of specific brain regions during Cyberball game, a validated exclusion task | comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation | At the inclusion, and 2 weeks after the end of the therapy | |
| Secondary | Activation of specific brain regions during a motivational task | comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation | At the inclusion, and 2 weeks after the end of the therapy | |
| Secondary | Change of activation of default mode network (DMN) during resting state acquisition | Comparison between groups | Baseline acquisition and 2 weeks after therapy | |
| Secondary | Baseline activation of DMN during resting state acquisition | Comparison between subjects with suicidal ideation versus without at 3 months after therapy | Baseline acquisition and clinical assessment at 3 months after therapy | |
| Secondary | Baseline fraction of anisotropy | Comparison between subjects with suicidal ideation versus without at 3 months after therapy | Baseline acquisition and clinical assessment at 3 months | |
| Secondary | Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS) | Comparison between the beginning and the end within each group and comparison between the two groups | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30) | Comparison between the beginning and the end within each group and comparison between the two groups | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of psychologic pain during the follow up | Comparison between the beginning and the end within each group and comparison between the two groups by Likert scale | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of anger during the follow up. | 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) | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of clinical global impression during the follow up. | Comparison between the beginning and the end within each group and comparison between the two groups by the CGI (Clinical Global Impressions scale) | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI) | Comparison between the beginning and the end within each group and comparison between the two groups | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy | |
| Secondary | Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS) | Comparison between the beginning and the end within each group and comparison between the two groups | At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy |