Feasibility of Internet-delivered CBT for Adolescents With Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Prior to a properly powered randomized controlled study, evaluating efficacy and
      cost-effectiveness of ICBT, we will conduct a pilot study to investigate if the trial design
      is feasible, if therapist-guided and self-guided internet-delivered cognitive behavioral
      therapy (ICBT) is acceptable for adolescents with depression and to provide preliminary
      clinical efficacy data.
    

Detailed description: 
      A single-blind parallel-group pilot randomised controlled feasibility trial with the overall
      aim to develop two internet-delivered cognitive behaviour therapy interventions,
      therapist-guided and self-guided, for adolescents with mild to moderate Major Depressive
      Disorder (MDD) and their primary caregivers.

      Patients can be either referred or self-referred. All potential participants are initially
      screened via telephone. This is followed by a face-to-face inclusion assessment. Participants
      who are eligible and have consented will be randomized into one of three trial arms;
      therapist-guided ICBT, self-guided ICBT or TAU. In the experimental arms, participants, e.g.
      the adolescent and at least one caregiver, either receive 10 weeks of therapist-guided or
      self-guided internet-delivered behavioural activation (BA). In the control arm, participants
      receive treatment as usual within the Child and Adolescent Mental Health Services (CAMHS) or
      primary care clinics. The primary endpoint will be at 3-month follow-up.

      The primary objective is to evaluate the feasibility of the study design and trial
      procedures, including recruitment, withdrawal, drop out and attrition rates. The secondary
      objective is to (a) evaluate the acceptability of the ICBT interventions in regard to
      treatment satisfaction, credibility, reported adverse events, and program use, (b) to provide
      preliminary clinical efficacy data, and (c) to gather qualitative information on the
      experience of undergoing ICBT for depression from the perspective of adolescent patients,
      their caregivers and potential areas for improvement of future ICBT interventions.
    

Intervention name(s): Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents; Self-guided internet-delivered cognitive behavior therapy for depression in adolescents; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.; Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.; Participants randomized to TAU, will be referred to the local CAMH's or primary care unit for children and youths and will be free to receive any treatment, either psychosocial, medical or the combination of both.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment