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

July 4, 2023 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
Time Frame: At 2 weeks after group completion
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
Time Frame: At 3 months after therapy
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
Time Frame: At 2 weeks after group completion
Comparison between inclusion and 2 weeks after group completion of cerebral activation within relaxation group
At 2 weeks after group completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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
At the inclusion, and 2 weeks after the end of the therapy
Activation of specific brain regions during Cyberball game, a validated exclusion task
Time Frame: 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
At the inclusion, and 2 weeks after the end of the therapy
Activation of specific brain regions during a motivational task
Time Frame: 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
At the inclusion, and 2 weeks after the end of the therapy
Change of activation of default mode network (DMN) during resting state acquisition
Time Frame: Baseline acquisition and 2 weeks after therapy
Comparison between groups
Baseline acquisition and 2 weeks after therapy
Baseline activation of DMN during resting state acquisition
Time Frame: Baseline acquisition and clinical assessment at 3 months after therapy
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
Time Frame: Baseline acquisition and clinical assessment at 3 months
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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.
Time Frame: 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)
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.
Time Frame: 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)
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)
Time Frame: 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
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)
Time Frame: 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
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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