Clinical trial NCT02936700: Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior
Official title: Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actual Suicidal Behavior Disorder
Keywords: Psychiatry
Suicide
Randomized controlled trial
ACT
fMRI
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
timeFrame: At 2 weeks after group completion
measure: Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
timeFrame: At 2 weeks after group completion
measure: Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task
timeFrame: At 3 months after therapy
Secondary outcomes:
measure: Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task
timeFrame: At the inclusion, and 2 weeks after the end of the therapy
measure: Activation of specific brain regions during Cyberball game, a validated exclusion task
timeFrame: At the inclusion, and 2 weeks after the end of the therapy
measure: Activation of specific brain regions during a motivational task
timeFrame: At the inclusion, and 2 weeks after the end of the therapy
measure: Change of activation of default mode network (DMN) during resting state acquisition
timeFrame: Baseline acquisition and 2 weeks after therapy
measure: Baseline activation of DMN during resting state acquisition
timeFrame: Baseline acquisition and clinical assessment at 3 months after therapy
measure: Baseline fraction of anisotropy
timeFrame: Baseline acquisition and clinical assessment at 3 months
measure: Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30)
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of psychologic pain during the follow up
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of anger during the follow up.
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of clinical global impression during the follow up.
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI)
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
measure: Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS)
timeFrame: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier Hospital University
Study officials:
References:
citation: 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.