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Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior (IMPACT)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Actual Suicidal Behavior Disorder

Treatments

Behavioral: ACT therapy
Behavioral: Relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT02936700
UF 9519
2014-A01781-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Control group
Other group
Description:
Add on relaxation group
Treatment:
Behavioral: Relaxation
Therapy ACT
Experimental group
Description:
Add on ACT group
Treatment:
Behavioral: ACT therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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