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

NCT03655730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2021-06-28

No results posted yet for this study

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

Conditions

  • Depressive Symptoms

Interventions

OTHER

weekly psychotherapeutic individual sessions

weekly psychotherapeutic individual sessions following the IPT method during one year

OTHER

Usual care

the standard follow-up provided by the Mission Locale, including periodic meetings with a referee

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Antoine Guedeney, PhD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2021-03-31
Completion
2021-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655730 on ClinicalTrials.gov