Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01781-46 | Other Identifier | Agence Nationale de Sécurité des Médicaments |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Add on relaxation group |
|
| Therapy ACT | Experimental | Add on ACT group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation | Behavioral | relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier Hospital University | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33884617 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ACT therapy | Behavioral | 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at
|
|
| 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 |
| 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 |
| Change of activation of default mode network (DMN) during resting state acquisition | Comparison between groups | Baseline acquisition and 2 weeks after therapy |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |