Actual Suicidal Behavior DisorderIMPACTNCT02936700
Biomarkers of Efficiency of Acceptance and Commitment Therapy in Suicidal Behavior
A study testing Relaxation and ACT therapy in people with Actual Suicidal Behavior Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Actual Suicidal Behavior Disorder
- What is being tested?
- Relaxation and ACT therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to 5 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Relaxation, ACT therapy
- Keywords
- Psychiatry, Suicide, Randomized controlled trial, ACT, fMRI
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxationBehavioural
relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.
ACT therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Add on relaxation group Receives: Behavioral: Relaxation |
| Therapy ACT | Experimental | Add on ACT group Receives: Behavioral: ACT therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
comparison between the two groups and before/after therapy / Association between baseline activation and improvement of suicidal ideation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMay 2015
- Primary completion5 Sep 2016
- Study completion5 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actual Suicidal Behavior DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936700
- Sponsor's protocol ID
- UF 9519
- Other IDs
- 2014-A01781-46
- Acronym
- IMPACT
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2016
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
- ClinicalTrials.gov ID
- NCT02936700
- Acronym / sponsor ID
- IMPACT / UF 9519
- Conditions
- Actual Suicidal Behavior Disorder
- Keywords
- Psychiatry, Suicide, Randomized controlled trial, ACT, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 5 Sep 2016 (actual)
- Study completion
- 5 Mar 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: RelaxationAdd on relaxation group |
| Therapy ACT | Experimental | Behavioral: ACT therapyAdd on ACT group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxationrelaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. | Behavioural | Control group |
| ACT therapy7 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 | Behavioural | Therapy ACT |
Primary outcome
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
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
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
13 secondary outcomes
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
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
Activation of specific brain regions during a motivational task
Time frame: 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
Baseline activation of DMN during resting state acquisition
Time frame: Baseline acquisition and clinical assessment at 3 months after therapy
Baseline fraction of anisotropy
Time frame: 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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and ACT therapy in people with Actual Suicidal Behavior Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task (time frame: At 2 weeks after group completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.