Depressive SymptomsMLADONCT03655730
Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
A study testing weekly psychotherapeutic individual sessions in people with Depressive Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries. Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- weekly psychotherapeutic individual sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2018to 30 Apr 2021
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be followed in one of the five participating centres of Mission Locale in Paris,
- Be between 16 (inclusive) and 25 (inclusive) years old at the date of inclusion,
- Agrees to participate in the research and, in the case of a minor, the legal representant agrees with the subject's participation in research.
- Have a Social Security number
- Be fluent in French
- With signed informed consent
Who cannot join
- Be already followed in a mental health/addiction service, attending to a private or public psychiatric service, or abusing drugs.
- Randomisation criteria :
- Included subjects will be randomised if at least one of the following conditions is met: baseline ADRSc score greater or equal than 8 or abuse and/or deprivation according to the Childhood Trauma Questionnaire (CTQ, short version):
- score greater or equal than 11 relative to physical abuse
- score greater or equal than 16 relative to emotional abuse
- score greater or equal than 14 relative to physical deprivation
- score greater or equal than 11 relative to sexual abuse).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacity of a Sustained Weekly Psychological Intervention for Adolescents and Young Adults Attending to Local Missions for Reinsertion, on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion Compared to Usual Care
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries.
Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt. To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS).
Read more
Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.
The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.
The study also aims comparing in the 2 randomised groups
- ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
- Number of suicidal attempts and self-harm attempts at 6 and 12 months
- Number of drop-out at 6 and 12 months
- Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
- Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
- Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
Read the detailed description
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries. In France, recent epidemiological data showed that the suicide rate in adolescents aged 15 to 19 is 4.1/100 000 inhabitants. Prevalence of suicidal ideations ranges from 15 to 25% in the general population and lifetime estimates of suicide attempts among adolescents range from 1.3 to 3.8% in males and from 1.5 to 10.1% in females. Reducing suicide and suicide attempts is therefore a key public health target.
Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt.
Being in a situation of failure at school or not having a clear training or work project clearly increases the risk for depression. Some studies have targeted potential high school drop outs as a target for prevention of suicidality.
To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS). However, only few studies assess, through a randomized protocol, efficacity and feasibility of psychotherapeutic treatment in psychiatry in general and particularly in this population, although individual psychotherapy is highly recommended in clinical practice for depressed adolescents and young adults.
Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.
The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.
Others objectives are the following :
To compare in the 2 randomised groups
- ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
- Number of suicidal attempts and self-harm attempts at 6 and 12 months
- Number of drop-out at 6 and 12 months
- Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
- Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
- Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
To describe, in the whole sample (randomised and not randomised),
- the baseline level of abuse during childhood with the CTQ. The effectiveness of reinsertion activities (jobs, diploma, attendance to the Mission Locale) at 0, 3, 6, 9 and 12 months
To evaluate the sensitivity to change of the French version of the ADRSc.
330 subjects wil be included to have 132 randomized subjects into two arms: sustained psychotherapeutic intervention or usual care.
- Conditions
- Depressive Symptoms
- Being tested
- weekly psychotherapeutic individual sessions, Usual care
- Keywords
- Depression, suicidal risk, self-harm behavior, young people
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly psychotherapeutic individual sessionsOther
weekly psychotherapeutic individual sessions following the IPT method during one year
Usual careOther
the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | follow weekly psychotherapeutic individual sessions following the IPT method during one year. Receives: Other: weekly psychotherapeutic individual sessions; Other: Usual care |
| usual care arm | Experimental | continue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression level
Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.
Measured: 6 months
Secondary outcomes (6)
depression assessed at 0, 3, 9 and 12 months
The ADRSc (clinician) questionnaire will be filled out by the assessor at 0, 3 and 9 and 12 months during follow-up visits
Measured: at 0, 3, 9 and 12 months
suicidal attempts and self-harm attempts
The number of suicidal attempts and self-harm attempts, at 6 and 12 months
Measured: at 6 and 12 months
drop out
The number of drop outs at baseline, 6 and 12 months
Measured: at baseline, 6 and 12 months
time of the hopelessness
The evolution on time of the hopelessness, assessed at 0, 3, 6, 9 and 12 months
Measured: t 0, 3, 6, 9 and 12 months
global score on the GHQ28
- The evolution on time of the global score on the GHQ28 and on its 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood), assessed at 0, 3, 6, 9 and 12 months
Measured: at 0, 3, 6, 9 and 12 months
working aIliance
The evolution on time of the working aIliance at 0, 3, 6, 9 and 12 months
Measured: at 0, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start3 Dec 2018
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a comparative, randomised controlled trial that aims at demonstrating the superiority of weekly psychotherapeutic intervention during one year in lowering depression symptoms compared to usual care. The ratio between intervention and usual care arms will be 1:1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Guedeney, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655730
- Sponsor's protocol ID
- K170104-J
- Other IDs
- 2018-A01255-50
- Acronym
- MLADO
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2018
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity of a Sustained Weekly Psychological Intervention for Adolescents and Young Adults Attending to Local Missions for Reinsertion, on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion Compared to Usual Care
- ClinicalTrials.gov ID
- NCT03655730
- Acronym / sponsor ID
- MLADO / K170104-J
- Conditions
- Depressive Symptoms
- Keywords
- Depression, suicidal risk, self-harm behavior, young people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries.
Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt. To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS).
Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.
The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.
The study also aims comparing in the 2 randomised groups
- ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
- Number of suicidal attempts and self-harm attempts at 6 and 12 months
- Number of drop-out at 6 and 12 months
- Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
- Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
- Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
Detailed description
Suicide is the third leading cause of death in adolescents and young adults in the United States and the second leading cause in European countries. In France, recent epidemiological data showed that the suicide rate in adolescents aged 15 to 19 is 4.1/100 000 inhabitants. Prevalence of suicidal ideations ranges from 15 to 25% in the general population and lifetime estimates of suicide attempts among adolescents range from 1.3 to 3.8% in males and from 1.5 to 10.1% in females. Reducing suicide and suicide attempts is therefore a key public health target.
Depressive disorders are consistently the most prevalent psychiatric disorder among adolescents who attempt suicide with a prevalence ranging from 49% to 64%. Depression in adolescent and young adults is a multifactorial phenomenon, as is the risk of suicidal attempt.
Being in a situation of failure at school or not having a clear training or work project clearly increases the risk for depression. Some studies have targeted potential high school drop outs as a target for prevention of suicidality.
To address such problems, effective and accessible treatment is needed, as recommended by the French Health Authority (HAS). However, only few studies assess, through a randomized protocol, efficacity and feasibility of psychotherapeutic treatment in psychiatry in general and particularly in this population, although individual psychotherapy is highly recommended in clinical practice for depressed adolescents and young adults.
Our primary objective is to demonstrate that a weekly psychotherapeutic intervention reduces the depression level.
The primary assessment criterion is the variation of the clinician Adolescent Depression Rating Scale (ADRSc) from randomisation to month 6.
Others objectives are the following :
To compare in the 2 randomised groups
- ADRS depression global score (clinician and subject) at 0, 3, 9 and 12 months
- Number of suicidal attempts and self-harm attempts at 6 and 12 months
- Number of drop-out at 6 and 12 months
- Beck's Hopelessness Scale at 0, 3, 6, 9 and 12 months
- Global score on the GHQ-28 and scores on the 4 subscales (Somatization, Anxiety and Insomnia, Social dysfunction, Depressive mood) at 0, 3, 6, 9 and 12 months.
- Working AIliance Inventory (WAI) score at 0, 3, 6, 9 and 12 months
To describe, in the whole sample (randomised and not randomised),
- the baseline level of abuse during childhood with the CTQ. The effectiveness of reinsertion activities (jobs, diploma, attendance to the Mission Locale) at 0, 3, 6, 9 and 12 months
To evaluate the sensitivity to change of the French version of the ADRSc.
330 subjects wil be included to have 132 randomized subjects into two arms: sustained psychotherapeutic intervention or usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a comparative, randomised controlled trial that aims at demonstrating the superiority of weekly psychotherapeutic intervention during one year in lowering depression symptoms compared to usual care. The ratio between intervention and usual care arms will be 1:1.
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: weekly psychotherapeutic individual sessions, Other: Usual carefollow weekly psychotherapeutic individual sessions following the IPT method during one year. |
| usual care arm | Experimental | Other: Usual carecontinue with the standard follow-up provided by the Mission Locale, including periodic meetings with a referee |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be followed in one of the five participating centres of Mission Locale in Paris,
- Be between 16 (inclusive) and 25 (inclusive) years old at the date of inclusion,
- Agrees to participate in the research and, in the case of a minor, the legal representant agrees with the subject's participation in research.
- Have a Social Security number
- Be fluent in French
Key exclusion criteria (7 listed)
- Be already followed in a mental health/addiction service, attending to a private or public psychiatric service, or abusing drugs.
- Included subjects will be randomised if at least one of the following conditions is met: baseline ADRSc score greater or equal than 8 or abuse and/or deprivation according to the Childhood Trauma Questionnaire (CTQ, short version):
- score greater or equal than 11 relative to physical abuse
- score greater or equal than 16 relative to emotional abuse
- score greater or equal than 14 relative to physical deprivation
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 |
|---|---|---|
| weekly psychotherapeutic individual sessionsweekly psychotherapeutic individual sessions following the IPT method during one year | Other | intervention arm |
| Usual carethe standard follow-up provided by the Mission Locale, including periodic meetings with a referee | Other | intervention arm, usual care arm |
Primary outcome
Depression level
Time frame: 6 months
Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.
6 secondary outcomes
depression assessed at 0, 3, 9 and 12 months
Time frame: at 0, 3, 9 and 12 months
suicidal attempts and self-harm attempts
Time frame: at 6 and 12 months
drop out
Time frame: at baseline, 6 and 12 months
time of the hopelessness
Time frame: t 0, 3, 6, 9 and 12 months
global score on the GHQ28
Time frame: at 0, 3, 6, 9 and 12 months
working aIliance
Time frame: at 0, 3, 6, 9 and 12 months
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 28 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antoine Guedeney, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weekly psychotherapeutic individual sessions in people with Depressive Symptoms, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 7 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 28 Jun 2021. 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?
Depression level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2021.