Feasibility of Internet-delivered CBT for Adolescents With Depression

Karolinska Institute

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents; Other: Treatment as usual; Behavioral: Self-guided internet-delivered cognitive behavior therapy for depression in adolescents

Study type: Interventional

Funder types: Other

Identifiers

NCT04117789

2019-03235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th ed.
• Willing to be randomized to either of the three treatment arms.
• Basic proficiency in Swedish, both adolescent and participating care-giver
• Regular access to a desktop or laptop computer connected to the internet, as well as a mobile phone to receive sms (one of each is enough per family).
• Stable medication with antidepressants, central stimulants and neuroleptics at least 6 weeks prior to inclusion.
• A minimum of one caregiver that is able to co-participate in the treatment.

Exclusion criteria

• Immediate risk to self or others, requiring urgent medical attention, such as suicidality, or repeated self-injurious behaviour.
• Other severe psychiatric disorders requiring other actions at first hand (e.g. diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, or alcohol/substance dependence;
• Current social problems requiring other actions at first hand (e.g. bullying in school, abuse and/or neglect in the family; high and prolonged absence from school).
• Previous CBT for MDD within the last 12 months prior to assessment, for a minimum of 3 sessions other than psychoeducation with a qualified therapist within the 12 months prior to assessment.
• Current use of benzodiazepines.
• An ongoing psychological treatment for any other psychiatric disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Therapist-guided ICBT for depression

Experimental group

Description:

Participants will receive internet-delivered CBT with therapist support. The treatment consists of 8 online chapters with interactive features as videos and illustrations, delivered over a maximum of 10 weeks. The treatment has the main focus on behavioral activation. The adolescent and the caregiver are provided with their own separate programs and login to the treatment platform. The parent program also consists of eight chapters, including psychoeducation about depression and how to support their adolescent in treatment. The adolescents and caregivers have regular contact with a personal assigned therapist via written text messages in the platform. Participants are typically in contact with their therapist several times a week. The adolescent and caregiver can continue to access all treatment modules for the whole follow-up period (3 months), but without therapist-support.

Treatment:

Behavioral: Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents

Self-guided ICBT for depression

Experimental group

Description:

The self-guided ICBT for depression is identical to the therapist-guided ICBT intervention, however without the therapist support. To ensure patient-safety, there will be clear instructions to the patients and primary caregivers how to get in contact with the study team in case of acute problems, and there will be clinical routines to detect and manage deterioration or suicidal tendencies.

Treatment:

Behavioral: Self-guided internet-delivered cognitive behavior therapy for depression in adolescents

Treatment as usual (TAU)

Active Comparator group

Description:

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. The content of TAU and the treatment techniques used, will be monitored.

Treatment:

Other: Treatment as usual