NCT02936700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2017

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

July 15, 2016

Last Update Submit

July 4, 2023

Conditions

Actual Suicidal Behavior Disorder

Keywords

PsychiatrySuicideRandomized controlled trialACTfMRI

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (13)

  • Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task

    At the inclusion, and 2 weeks after the end of the therapy

  • Activation of specific brain regions during Cyberball game, a validated exclusion task

    At the inclusion, and 2 weeks after the end of the therapy

  • Activation of specific brain regions during a motivational task

    At the inclusion, and 2 weeks after the end of the therapy

  • Change of activation of default mode network (DMN) during resting state acquisition

    Baseline acquisition and 2 weeks after therapy

  • Baseline activation of DMN during resting state acquisition

    Baseline acquisition and clinical assessment at 3 months after therapy

  • +8 more secondary outcomes

Study Arms (2)

Control group

OTHER

Add on relaxation group

Behavioral: Relaxation

Therapy ACT

EXPERIMENTAL

Add on ACT group

Behavioral: ACT therapy

Interventions

RelaxationBEHAVIORAL

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

Control group
ACT therapyBEHAVIORAL

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

Therapy ACT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier Hospital University

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 33884617DERIVED

MeSH Terms

Conditions

Suicide

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2016

First Posted

October 18, 2016

Study Start

May 1, 2015

Primary Completion

September 5, 2016

Study Completion

March 5, 2017

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)