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

NCT04977856 | Active Not Recruiting DMC

• 1 other identifier: 2021-0859
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  CDRS-R is a semi-structured clinician interview, assessing level of depressive symptomatology. Total range is 17-113, with higher values representing a worse outcome.

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

Secondary Outcomes (19)

• Clinical Global Impression Scale - Severity (CGI-S)

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

• Clinical Global Impression - Improvement (CGI-I)

  week 10, at 3- and 12 months follow-up

• Children's global assessment scale (CGAS)

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

• Internet Intervention Patient Adherence Scale (iiPAS)

  Week 10

• Anhedonia Scale for Adolescents (ASA)

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

Study Arms (3)

Guided ICBT

EXPERIMENTAL

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.

Behavioral: Behavioral activation (BA)

Self-guided ICBT

EXPERIMENTAL

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.

Behavioral: Behavioral activation (BA)

Treatment as usual (TAU)

ACTIVE COMPARATOR

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.

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

Interventions

Behavioral activation (BA) BEHAVIORAL

The main goal of the BA is to increase engagement in values-based activities and decrease avoidant behaviors that serve to maintain depression. The adolescent will learn about depression, how behavioral activations works, monitor their own activities, plan and do more values-based activities and deal with obstacles to getting in touch with positive reinforcement, such as avoidance behaviors.

Guided ICBT; Self-guided ICBT

Regular care within primary or secondary mental health care for children OTHER

Regular care (supportive therapy, waitlist, psychological treatments, drugs, or a combination of different interventions)

Treatment as usual (TAU)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• A minimum of one caregiver that is able to co-participate in the treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

BUP Internetbehandling, BUP Forsknings- och utvecklingscentrum i Stockholm

Stockholm, Stockholm County, 11364, Sweden

Location

Related Publications (1)

• Andersson R, Vigerland S, Lenhard F, Ahlen J, Bottai M, Mataix-Cols D, Serlachius E. Single-blinded, randomised, parallel-group, controlled trial comparing the efficacy and cost-effectiveness of therapist- and self-guided internet-delivered behavioural activation versus treatment as usual for adolescents with mild to moderate depression: study protocol. BMJ Open. 2024 Oct 15;14(10):e083507. doi: 10.1136/bmjopen-2023-083507.

  PMID: 39414268 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Eva Serlachius, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. The outcome measures are identical for both groups, ensuring that the assessors remain blind. At each follow-up assessment, participants will be reminded by their assessor to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation at each assessment point and motivate their choice. The blinding will be broken after the trial's final participant has finished his/her 3-month follow-up assessment (primary endpoint). The trial will end when the trial's final participant has finished his/her 3-month follow-up assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single-blind parallel-group randomised controlled trial

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 27, 2021
• Study Start: September 10, 2021
• Primary Completion: October 14, 2024
• Study Completion: July 31, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)