Feasibility of Internet-delivered CBT for Adolescents With Depression

NCT04117789 | Completed

• 1 other identifier: 2019-03235
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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. Change from baseline in depressive symptom severity on the CDRS-R at end of treatment, and at 3-months follow-up will be reported. Primary endpoint is 3 months follow-up.

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

Secondary Outcomes (16)

• Treatment credibility and expectancy scale - adolescent and parent version

  week 3

• The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version

  week 10, at 3 months follow-up

• Need for further treatment - adolescent and parent version

  week 10, at 3 months follow-up

• Negative Effects Questionnaire (NEQ-20) - adolescent and parent version

  week 5, week 10, at 3 months-follow up

• Treatment completion

  week 10

Other Outcomes (2)

• Behavioral activation of Depression Scale - short form (BADS-S)

  weekly during treatment (week 1 to week 10)

• Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)

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

Study Arms (3)

Therapist-guided ICBT for depression

EXPERIMENTAL

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.

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

Self-guided ICBT for depression

EXPERIMENTAL

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.

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

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

Other: Treatment as usual

Interventions

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

Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.

Therapist-guided ICBT for depression

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

Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.

Self-guided ICBT for depression

Treatment as usual OTHER

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.

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:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Child and Adolescent Psychiatry Research Center

Stockholm, 11330, Sweden

Location

Related Publications (2)

• Andersson R, Vigerland S, Ahlen J, Widstrom H, Unger I, Serlachius E, Engberg H. "Therapy without a therapist?" The experiences of adolescents and their parents of online behavioural activation for depression with and without therapist support. Eur Child Adolesc Psychiatry. 2024 Jan;33(1):105-114. doi: 10.1007/s00787-023-02142-7. Epub 2023 Jan 17.

  PMID: 36650254 DERIVED

• Grudin R, Ahlen J, Mataix-Cols D, Lenhard F, Henje E, Mansson C, Sahlin H, Beckman M, Serlachius E, Vigerland S. Therapist-guided and self-guided internet-delivered behavioural activation for adolescents with depression: a randomised feasibility trial. BMJ Open. 2022 Dec 26;12(12):e066357. doi: 10.1136/bmjopen-2022-066357.

  PMID: 36572500 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Eva Serlachius, MD, 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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 7, 2019
• Study Start: October 14, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 21, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

SE (1)