Clinical trial NCT04977856: Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents with Depression
Official title: Efficacy and Cost-effectiveness of Internet-delivered Cognitive Behavior Therapy for Adolescents with Mild to Moderate Depression: a Randomized Controlled Trial of Guided and Self-guided ICBT Vs. Treatment As Usual
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2021-07-27
Enrollment: 215
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind parallel-group randomised controlled trial
Primary purpose: TREATMENT

Brief 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).

Detailed description: Primary and secondary objectives

Primary objective:

1. To determine the clinical efficacy of Guided and Self-guided ICBT for depression for reducing depressive symptom severity (as measured by the CDRS-R (27) in adolescents with mild and moderate major depressive disorder (MDD), compared with an active control intervention (treatment as usual within primary or secondary child and adolescent mental health care). The primary endpoint is the follow-up 3 months post-treatment.

Secondary objectives:

1. To establish the 12-month durability of the treatment effects.
2. To conduct a health-economic evaluation of guided ICBT for depression and self-guided ICBT for depression, compared with TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up).
3. To investigate potential mediators behind a potential treatment effect of ICBT.

Research questions:

1. Is guided and self-guided ICBT more efficacious than TAU in regard to the reduction of depressive symptoms?
2. Is guided and self-guided ICBT more cost-effective than TAU?
3. Is self-guided ICBT more cost-effective than guided ICBT?
4. Are the therapeutic gains of ICBT maintained long term (i.e., 1 year after the intervention)?
5. Do changes in activation and avoidance (BADS) mediate changes at post-treatment in self-reported depressive symptoms (QIDS-A-17) in adolescents receiving ICBT (with or without therapist support), but not in the control group (treatment as usual)?

Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: week 0, week 10, at 3 and 12 months follow-up
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: week 10, at 3- and 12 months follow-up
measure: Children's global assessment scale (CGAS)
timeFrame: week 0, week 10, at 3 and 12 months follow-up
measure: Internet Intervention Patient Adherence Scale (iiPAS)
timeFrame: Week 10
measure: Anhedonia Scale for Adolescents (ASA)
timeFrame: week 0, week 10, at 3 and 12 months follow-up
measure: Affective Reactivity Index (ARI)
timeFrame: week 0, week 10, at 3 and 12 months follow-up
measure: Behavioral activation of Depression Scale - short form (BADS-S)
timeFrame: week 0, weekly during treatment (week 1 to week 10), at 3- and 12 months follow-up
measure: Concomitant interventions
timeFrame: Week 10 and 3- and 12-months follow-up assessments.
measure: The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version
timeFrame: week 10
measure: Insomnia Severity Index (ISI)
timeFrame: week 0, week 10, and at 3- and 12 months follow-up
measure: Kidscreen-10 Index - adolescent and parent version
timeFrame: week 0, week 10, at 3- and 12-months follow-up
measure: Need for further treatment - adolescent and parent version
timeFrame: at 3 months follow-up
measure: Negative Effects Questionnaire (NEQ-20) - adolescent and parent version
timeFrame: Week 10 and 3 months follow-up
measure: The Revised Children's Anxiety and Depression Scale, short (RCADS-S) -adolescent and parent version
timeFrame: week 0, week 10, 3- and 12 months follow-up
measure: Quick Inventory of Depressive Symptomatology, 17 items (QIDS-17) - adolescent and parent version
timeFrame: week 0, weekly from week 1 to week 10, at 3- and 12 months follow-up
measure: Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version
timeFrame: week 0, week 10, 3- and 12 months follow-up
measure: The Expressed Emotion Adjective Checklist (EEAC)
timeFrame: week 0, week 10, 3- and 12 months follow-up
measure: Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
timeFrame: week 0, week 10, at 3- and 12 months follow-up
measure: Treatment credibility - adolescent and parent version
timeFrame: week 3
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: BUP Internetbehandling, BUP Forsknings- och utvecklingscentrum i Stockholm
state: Stockholms län
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, PhD
role: PRINCIPAL_INVESTIGATOR
References: