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

Primary Purpose

Actual Suicidal Behavior Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Relaxation
ACT therapy
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Actual Suicidal Behavior Disorder focused on measuring Psychiatry, Suicide, Randomized controlled trial, ACT, fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Montpellier Hospital University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control group

Therapy ACT

Arm Description

Add on relaxation group

Add on ACT group

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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
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
Change of activation of default mode network (DMN) during resting state acquisition
Comparison between groups
Baseline activation of DMN during resting state acquisition
Comparison between subjects with suicidal ideation versus without at 3 months after therapy
Baseline fraction of anisotropy
Comparison between subjects with suicidal ideation versus without at 3 months after therapy
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
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
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
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)
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)
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
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

Full Information

First Posted
July 15, 2016
Last Updated
July 4, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02936700
Brief Title
Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior
Acronym
IMPACT
Official Title
Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
September 5, 2016 (Actual)
Study Completion Date
March 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actual Suicidal Behavior Disorder
Keywords
Psychiatry, Suicide, Randomized controlled trial, ACT, fMRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Add on relaxation group
Arm Title
Therapy ACT
Arm Type
Experimental
Arm Description
Add on ACT group
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Intervention Description
relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.
Intervention Type
Behavioral
Intervention Name(s)
ACT therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
Description
Comparison between inclusion and 2 weeks after group completion of cerebral activation within ACT group
Time Frame
At 2 weeks after group completion
Title
Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
Description
Comparison between inclusion and 2 weeks after group completion of cerebral activation within relaxation group
Time Frame
At 2 weeks after group completion
Title
Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task
Description
comparison between subjects with suicidal ideation vs. without suicidal ideation at 3 months after therapy
Time Frame
At 3 months after therapy
Secondary Outcome Measure Information:
Title
Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task
Description
comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation
Time Frame
At the inclusion, and 2 weeks after the end of the therapy
Title
Activation of specific brain regions during Cyberball game, a validated exclusion task
Description
comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation
Time Frame
At the inclusion, and 2 weeks after the end of the therapy
Title
Activation of specific brain regions during a motivational task
Description
comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation
Time Frame
At the inclusion, and 2 weeks after the end of the therapy
Title
Change of activation of default mode network (DMN) during resting state acquisition
Description
Comparison between groups
Time Frame
Baseline acquisition and 2 weeks after therapy
Title
Baseline activation of DMN during resting state acquisition
Description
Comparison between subjects with suicidal ideation versus without at 3 months after therapy
Time Frame
Baseline acquisition and clinical assessment at 3 months after therapy
Title
Baseline fraction of anisotropy
Description
Comparison between subjects with suicidal ideation versus without at 3 months after therapy
Time Frame
Baseline acquisition and clinical assessment at 3 months
Title
Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS)
Description
Comparison between the beginning and the end within each group and comparison between the two groups
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30)
Description
Comparison between the beginning and the end within each group and comparison between the two groups
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of psychologic pain during the follow up
Description
Comparison between the beginning and the end within each group and comparison between the two groups by Likert scale
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of anger during the follow up.
Description
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)
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of clinical global impression during the follow up.
Description
Comparison between the beginning and the end within each group and comparison between the two groups by the CGI (Clinical Global Impressions scale)
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI)
Description
Comparison between the beginning and the end within each group and comparison between the two groups
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Title
Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS)
Description
Comparison between the beginning and the end within each group and comparison between the two groups
Time Frame
At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Montpellier Hospital University
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33884617
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.
Results Reference
derived

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Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior

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