Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior

NCT ID: NCT02936700

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-03-05

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

Conditions

Actual Suicidal Behavior Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

Add on relaxation group

Group Type: OTHER

Relaxation

Intervention Type: BEHAVIORAL

relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.

Therapy ACT

Add on ACT group

Group Type: EXPERIMENTAL

ACT therapy

Intervention Type: BEHAVIORAL

7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at

• decreasing the tendency to try to escape unpleasant mental experiences
• increasing psychological flexibility
• developing acceptance of psychological events and engagement in valued actions

Interventions

Relaxation

relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.

Intervention Type: BEHAVIORAL

ACT therapy

7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at

• decreasing the tendency to try to escape unpleasant mental experiences
• increasing psychological flexibility
• developing acceptance of psychological events and engagement in valued actions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpellier Hospital University

Montpellier, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Other Identifiers

2014-A01781-46

Identifier Type: OTHER

Identifier Source: secondary_id

UF 9519

Identifier Type: -

Identifier Source: org_study_id