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Treatment Interrupts Depression Early
Sponsor: Nova Scotia Health Authority
Summary
The TIDE project aims to establish personal indicators for initial treatment choice for youth with first episode depression. Specifically, 100 adolescents and young adults (age 12 to 25) with untreated major depressive disorder of recent onset will be randomly allocated in 1:1 ratio to one of two evidence-based regimens for youth depression: (A) Individual cognitive-behavioural therapy; and (B) Optimized pharmacological treatment with an antidepressant. All participants will be offered active treatment for up to 1 year and follow-up for 2 years to establish short- and long-term outcomes, including change in depressive symptoms, maintenance of remission, core role functioning, achievement of educational, occupational and social milestones, and quality of life. Baseline characteristics including duration of untreated depression, pre-existing anxiety, attention-deficit/hyperactivity disorder, substance use, symptoms of reduced interest and activity, sleep, rhythm and melody of speech, brain function, history of childhood adversity, coping style, repetitive thinking, and family history of depression and bipolar disorder will be tested as potential moderators of outcome. Characteristics that differentially predict outcomes in those allocated to initial cognitive-behavioural therapy and those allocated to initial treatment with antidepressants will be combined into a personalized allocation algorithm.
Key Details
Gender
All
Age Range
12 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-12-02
Completion Date
2028-12-31
Last Updated
2025-05-14
Healthy Volunteers
No
Conditions
Interventions
Cognitive-Behavioural Therapy
20 sessions of individual CBT are offered over 16 weeks, conducted 1-on-1, with a trained and supervised therapist. Participants will learn about the cognitive, behavioural, emotional, and environmental factors which contribute to maintaining their depression. They will apply skills to interrupt unhelpful cognitive and behavioural patterns and engage in guided exploration to improve self-understanding. CBT is a structured and collaborative treatment. Weekly "homework" will be used to maximize opportunities for practice and consolidation of new skills. The individual sessions can be combined with optional family/parent/partner sessions, depending on the situation and preferences of the participant. All sessions will be video-recorded to allow high-quality supervision, fidelity- and quality-assurance. This corresponds to evidence available for CBT for adolescents and young adults that is established as the best practice through rigorous trials.
Antidepressant medication
The choice of antidepressants follows best-established evidence for treating depression in adolescents and young adults. We will offer treatment with fluoxetine, starting at 10mg a day, increasing to 20mg a day after 1 week if tolerated; a protocol established as safe and effective in adolescents and adults in multiple trials. Additional increases to 40 or 60mg will be possible based on positive effects and side-effects and clinical judgement, as recommended in this age group. In cases of intolerance or adverse reaction to fluoxetine, we will switch to sertraline (25-200mg) or escitalopram (5-20mg), two antidepressants licensed by the FDA for major depressive disorder in adolescents. Treatment will be optimized over 16 weeks, a time-frame comparable to the CBT arm. Pharmacotherapy will be managed and prescribed by qualified psychiatrists when starting treatment and reviewed after 1 week, 2 weeks and then in 2-weekly intervals for the remainder of the 16 weeks acute treatment period.
Locations (2)
Nova Scotia Health
Halifax, Nova Scotia, Canada
Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l'Île-de-Montréal / Centre de Recherche Douglas (Montreal West Island IUHSSC / Douglas Research Center)
Montreal, Quebec, Canada