Efficacy and Cost-effectiveness of Internet-delivered CBT for Adolescents with Depression (IDA)

Region Stockholm

Status: Active, not recruiting

Conditions: Major Depressive Disorder

Treatments: Behavioral: Behavioral activation (BA); Other: Regular care within primary or secondary mental health care for children

Study type: Interventional

Funder types: Other

Identifiers

NCT04977856

2021-0859

Details and patient eligibility

About

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).

Full 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)?

Enrollment: 215 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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215 participants in 3 patient groups

Guided ICBT

Experimental group

Description:

Participants in guided ICBT will receive internet-delivered CBT with therapist support. The treatment consists of 8 online modules with interactive features such as videos and illustrations, delivered over a maximum of 10 weeks. The main treatment focus is behavioral activation. The adolescent and the caregiver are provided with their own separate programs and login to the treatment platform. The caregiver's program also consists of 8 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: Behavioral activation (BA)

Self-guided ICBT

Experimental group

Description:

The self-guided arm is identical to the guided arm, however without the therapist support. To ensure patient safety, there will be clear instructions to the patients and primary caregivers on 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: Behavioral activation (BA)

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 a combination of both. The content of TAU and the treatment techniques used will be monitored.

Treatment:

Other: Regular care within primary or secondary mental health care for children