Effectiveness Trial of the French Blues Indicated Depression Prevention Program

Depression Clinical Trial

— French Blues  

Official title:

Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731053
• Other study ID #: FRQSC2016-NP-191870
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2016
• Last updated: September 26, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: September 2017
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to test the effectiveness of French adaptation of the Blues program, a school-based indicated depression prevention intervention. The program will be delivered by the endogenous psycho-social staff of 3 Montreal secondary schools to adolescents with sub-clinical depressive symptoms and compared to a no-intervention (Informational Brochure only) control condition, designed to represent the "usual intervention" in these schools.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)

Exclusion Criteria:

• Current major depression diagnosis

• Current active suicidal behaviors

• Being in a special school curriculum for academic or behavioral problems

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Blues program
Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)		6 months
Primary	Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)		6 months
Primary	Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)		6 months
Primary	Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in social adjustment as measured using "Évaluation sociale de Soi chez les jeunes adultes" questionnaire (Michaud et al., 2006) (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in affective school engagement as measured using a subscale of the school engagement questionnaire (Archambault et al., 2009) (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)		6 months
Secondary	Change in delinquent behaviors as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)		6 months