I-CARE: A Pilot Study of Cognitive Behavioural Therapy(CBT) for Mood and Anxiety Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

CBT-MyOWL: 12-sessions of CBT-MyOWL

CBT-as-usual: 12-sessions of CBT using Mind Over Mood or Anxiety Phobia

Study summary

The goal of this clinical trial is to learn if CBT(Cognitive Behavioural Therapy)-MyOWL(Optimizing Wellness through Literature) is feasible, leads to better patient retention, and has high acceptability by youth psychiatric outpatients with mood and/or anxiety disorder aged 14-19. The main questions it aims to answer are:

Primary Objective (feasibility): To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.

Primary Objective (acceptability): To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.

Secondary Objectives:

1. To determine whether CBT-MyOWL enhances time of retention compared to CBT-as-usual.
2. To determine whether youth who receive CBT-MyOWL have improved scores on all of the following over the course of treatment and endpoint compared to youth who receive CBT-as usual: i) depression and anxiety ii) suicidal ideation, iii) self-harm, and iv) coping and emotional resiliency.

Participants will:

Participate in 12 sessions of either CBT-MyOWL or CBT-as-usual (active control) Completes 4-5 questionnaires at sessions 3,6,9,12 Complete the acceptability and exit interview at session 12

Eligibility

Primary outcome measure(s)

• Dropout rates — Comparing the baseline and across the 12 weeks
  To determine whether a clinically meaningful proportion of youth complete a full course of CBT-MyOWL / CBT-as-usual.
• Acceptability Questionnaire — 12 week session
  To determine whether the CBT-MyOWL and CBT-as-usual interventions delivered are acceptable to youth participants.\* \*Note, given that CBT-as-usual is the gold standard treatment, we assume it will be feasible and acceptable and are mainly interested in the feasibility and acceptability of CBT-MyOWL. However, we believe it is important to measure both and will report on any differences identified.

Trial sites (1)

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