Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior
- Conditions
- Actual Suicidal Behavior Disorder
- Interventions
- Behavioral: RelaxationBehavioral: ACT therapy
- Registration Number
- NCT02936700
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Relaxation Add on relaxation group Therapy ACT ACT therapy Add on ACT group
- Primary Outcome Measures
Name Time Method Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task At 2 weeks after group completion Comparison between inclusion and 2 weeks after group completion of cerebral activation within relaxation group
Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task At 3 months after therapy comparison between subjects with suicidal ideation vs. without suicidal ideation at 3 months after therapy
- Secondary Outcome Measures
Name Time Method Change of activation of default mode network (DMN) during resting state acquisition Baseline acquisition and 2 weeks after therapy Comparison between groups
Baseline activation of DMN during resting state acquisition Baseline acquisition and clinical assessment at 3 months after therapy Comparison between subjects with suicidal ideation versus without at 3 months after therapy
Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task 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
Activation of specific brain regions during a motivational task 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
Activation of specific brain regions during Cyberball game, a validated exclusion task 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
Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30) 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
Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI) 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
Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS) 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
Baseline fraction of anisotropy Baseline acquisition and clinical assessment at 3 months Comparison between subjects with suicidal ideation versus without at 3 months after therapy
Evolution of psychologic pain during the follow up 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
Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS) 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
Evolution of anger during the follow up. 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)
Evolution of clinical global impression during the follow up. 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)
Trial Locations
- Locations (1)
Montpellier Hospital University
🇫🇷Montpellier, France