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

Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder

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.

Study Overview

• Status: Completed
• Conditions: Actual Suicidal Behavior Disorder
• Intervention / Treatment: Behavioral: Relaxation; Behavioral: ACT therapy

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

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier Hospital University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Add on relaxation group	Behavioral: Relaxation; relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.
Experimental: Therapy ACT; Add on ACT group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 5, 2016
• Study Completion (Actual): March 5, 2017

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimated): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; fMRI; Psychiatry; Suicide; ACT
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: UF 9519; 2014-A01781-46 (Other Identifier: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO