Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion

Depressive Symptoms Clinical Trial

— MLADO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655730
• Other study ID #: K170104-J
• Secondary ID: 2018-A01255-50
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Suicidal Ideation

Intervention

Other:
• weekly psychotherapeutic individual sessions
weekly psychotherapeutic individual sessions following the IPT method during one year
• Usual care
the standard follow-up provided by the Mission Locale, including periodic meetings with a referee

Locations

Country	Name	City	State
France	Bichat hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression level	Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.	6 months
Secondary	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	at 0, 3, 9 and 12 months
Secondary	suicidal attempts and self-harm attempts	The number of suicidal attempts and self-harm attempts, at 6 and 12 months	at 6 and 12 months
Secondary	drop out	The number of drop outs at baseline, 6 and 12 months	at baseline, 6 and 12 months
Secondary	time of the hopelessness	The evolution on time of the hopelessness, assessed at 0, 3, 6, 9 and 12 months	t 0, 3, 6, 9 and 12 months
Secondary	global score on the GHQ28	5. 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	at 0, 3, 6, 9 and 12 months
Secondary	working aIliance	The evolution on time of the working aIliance at 0, 3, 6, 9 and 12 months	at 0, 3, 6, 9 and 12 months