NCT04117789

Feasibility of Internet-delivered CBT for Adolescents With Depression

Feasibility of Internet-delivered Cognitive Behavior Therapy for Adolescents With Mild to Moderate Depression: A Randomized Pilot Study Comparing Therapist-guided vs. Self-guided ICBT vs. Treatment as Usual

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents	Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.
BEHAVIORAL	Self-guided internet-delivered cognitive behavior therapy for depression in adolescents	Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.
OTHER	Treatment as usual	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.

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-10-15
• Completion: 2020-10-21
• First posted: 2019-10-07
• Last updated: 2020-10-28

Locations

1 site across 1 country: Sweden