Clinical trial NCT03655730: Efficacity of Psychological Intervention on Reducing the Suicidal Ideations, Depression Level and Improving Reinsertion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: Depression
suicidal risk
self-harm behavior
young people
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 159
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Depression level
timeFrame: 6 months
Secondary outcomes:
measure: depression assessed at 0, 3, 9 and 12 months
timeFrame: at 0, 3, 9 and 12 months
measure: suicidal attempts and self-harm attempts
timeFrame: at 6 and 12 months
measure: drop out
timeFrame: at baseline, 6 and 12 months
measure: time of the hopelessness
timeFrame: t 0, 3, 6, 9 and 12 months
measure: global score on the GHQ28
timeFrame: at 0, 3, 6, 9 and 12 months
measure: working aIliance
timeFrame: at 0, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat hospital
Study officials:
affiliation: APHP
name: Antoine Guedeney, PhD
role: PRINCIPAL_INVESTIGATOR
References: