CompletedNot Applicable

Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents With Depression

Sweden219 participantsStarted 2021-09-10

Plain-language summary

Adolescent depression is a prevalent and impairing condition that can be effectively treated with Cognitive Behavior Therapy (CBT). However, a majority of adolescents do not have access to CBT. Internet-delivered CBT (ICBT) has been suggested as a way to increase availability to effective psychological treatments. Yet, the research on ICBT for adolescents has been lagging behind significantly. The overall aim of this research project is to increase the availability of evidence-based psychological treatments for adolescents with depression by developing and evaluating internet-delivered Cognitive Behavior Therapy (ICBT) for this target group. The main objectives are to establish the efficacy, cost-effectiveness, and long-term effects of the guided and self-guided ICBT for adolescents with mild to moderate depression in a randomized controlled trial (RCT) with three-arms; guided ICBT (with therapist-support) and self-guided ICBT (without therapist-support) vs treatment as usual (TAU).

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 13-17 years of age, * A diagnosis of mild to moderate MDD based on the DSM-5, * Willing to be randomized to either of the three treatment arms, * Basic proficiency in Swedish, both adolescent, and a participating caregiver * Regular access to a desktop, laptop computer connected to the internet, as well as a mobile phone, * If using medication with antidepressants, central stimulants, or neuroleptics it has to be unchanged at least 6 weeks prior to inclusion, and * A minimum of one caregiver that is able to co-participate in the treatment. Exclusion Criteria: * The presence of psychiatric problems requiring immediate treatment (e.g., high risk of suicide, psychosis, severe self-injury, bipolar disorder, clinical eating disorder, alcohol/substance abuse), * Social problems requiring immediate action (e.g., ongoing abuse in the family, high and prolonged absence from school); * Previous psychological treatment for MDD (CBT, interpersonal psychotherapy (IPT), or BA) for a minimum of at least 3 sessions within the last 12 months prior to assessment. * Current use of benzodiazepines. * Ongoing psychological treatment for any psychiatric disorder.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in clinician-rated depressive scores on Children's Depression Rating Scale - Revised (CDRS-R)

Timeframe: week 0, week 10, at 3 and 12 months follow-up

Trial details

NCT IDNCT04977856

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-10-14

View on ClinicalTrials.gov More Major Depressive Disorder trials