DepressionPhase 4French BluesNCT02731053
Effectiveness Trial of the French Blues Indicated Depression Prevention Program
A Phase 4 study testing Blues program in people with Depression, run by Université de Montréal at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression
- What is being tested?
- Blues program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)
Who cannot join
- Current major depression diagnosis
- Current active suicidal behaviors
- Being in a special school curriculum for academic or behavioral problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program
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.
- Conditions
- Depression
- Being tested
- Blues program
- Keywords
- Depression, Prevention, Adolescents, School, Effectiveness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blues programBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Blues program | Experimental | 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) Receives: Behavioral: Blues program |
| Control | No intervention | Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)
Measured: 6 months
Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)
Measured: 6 months
Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)
Measured: 6 months
Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)
Measured: 6 months
Secondary outcomes (6)
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)
Measured: 6 months
Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)
Measured: 6 months
Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Measured: 6 months
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)
Measured: 6 months
Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Measured: 6 months
Change in delinquent behaviors as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric N. Brière, PhD, Université de Montréal
- Investigators
- Frederic N Briere, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731053
- Sponsor's protocol ID
- FRQSC2016-NP-191870
- Acronym
- French Blues
- Status last verified
- Sep 2017
- First submitted
- 15 Mar 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Effectiveness Trial of the French Blues Indicated Depression Prevention Program
- ClinicalTrials.gov ID
- NCT02731053
- Acronym / sponsor ID
- French Blues / FRQSC2016-NP-191870
- Conditions
- Depression
- Keywords
- Depression, Prevention, Adolescents, School, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blues program | Experimental | Behavioral: Blues programParticipants 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) |
| Control | No intervention | –Participants will receive a brochure describing the nature, causes, and consequences of depression, as well as available prevention/treatment options |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Elevated depressive symptoms (score of 20 or above on the Center for Epidemiological Studies - Depression screening questionnaire)
Key exclusion criteria (3 listed)
- Current major depression diagnosis
- Current active suicidal behaviors
- Being in a special school curriculum for academic or behavioral problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blues programParticipants 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) | Behavioural | Blues program |
Primary outcome
Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up)
Time frame: 6 months
Change in depressive symptoms as measured using continuous SCID scores (baseline, posttest, 6-month follow-up)
Time frame: 6 months
Change in depressive symptoms as measured using the CES-D questionnaire (baseline, posttest, 6-month follow-up)
Time frame: 6 months
Change in depressive symptoms as measured using the PHQ-9 questionnaire (baseline, posttest, 6-month follow-up)
Time frame: 6 months
6 secondary outcomes
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)
Time frame: 6 months
Change in anxiety symptoms as measured using the SCAS questionnaire (baseline, posttest, 6-month follow-up)
Time frame: 6 months
Change in parent-child relationship as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time frame: 6 months
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)
Time frame: 6 months
Change in substance use as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time frame: 6 months
Change in delinquent behaviors as measured using a scale from the MASPAQ questionnaire (Leblanc, 1996) (baseline, posttest, 6-month follow-up)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic N Briere, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blues program in people with Depression, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who develop a major depressive episode as measured using the SCID diagnostic interview (posttest, 6 month follow-up) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.