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

NCT03655730 | Completed

• 2 other identifiers: K170104-J2018-A01255-50
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Conditions

Depressive Symptoms

Keywords

Depression; suicidal risk; self-harm behavior; young people

Outcome Measures

Primary Outcomes (1)

• Depression level

  Defined as the difference of ADRS clinician score (cf. Appendix 18.2.1) between inclusion and 6 month.

  6 months

Secondary Outcomes (6)

• depression assessed at 0, 3, 9 and 12 months

  at 0, 3, 9 and 12 months

• suicidal attempts and self-harm attempts

  at 6 and 12 months

• drop out

  at baseline, 6 and 12 months

• time of the hopelessness

  t 0, 3, 6, 9 and 12 months

• global score on the GHQ28

  at 0, 3, 6, 9 and 12 months

Study Arms (2)

intervention arm

EXPERIMENTAL

follow weekly psychotherapeutic individual sessions following the IPT method during one year.

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

Other: Usual care

Interventions

weekly psychotherapeutic individual sessions OTHER

weekly psychotherapeutic individual sessions following the IPT method during one year

intervention arm

Usual care OTHER

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

intervention arm; usual care arm

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be followed in one of the five participating centres of Mission Locale in Paris,
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Antoine Guedeney, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: August 31, 2018
• Study Start: December 3, 2018
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

FR (1)