Feasibility of Internet-delivered CBT for Adolescents With Depression
NCT ID: NCT04117789
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2019-10-14
2020-10-21
Brief Summary
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Detailed Description
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Patients can be either referred or self-referred. All potential participants are initially screened via telephone. This is followed by a face-to-face inclusion assessment. Participants who are eligible and have consented will be randomized into one of three trial arms; therapist-guided ICBT, self-guided ICBT or TAU. In the experimental arms, participants, e.g. the adolescent and at least one caregiver, either receive 10 weeks of therapist-guided or self-guided internet-delivered behavioural activation (BA). In the control arm, participants receive treatment as usual within the Child and Adolescent Mental Health Services (CAMHS) or primary care clinics. The primary endpoint will be at 3-month follow-up.
The primary objective is to evaluate the feasibility of the study design and trial procedures, including recruitment, withdrawal, drop out and attrition rates. The secondary objective is to (a) evaluate the acceptability of the ICBT interventions in regard to treatment satisfaction, credibility, reported adverse events, and program use, (b) to provide preliminary clinical efficacy data, and (c) to gather qualitative information on the experience of undergoing ICBT for depression from the perspective of adolescent patients, their caregivers and potential areas for improvement of future ICBT interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapist-guided ICBT for depression
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.
Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents
Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.
Self-guided ICBT for depression
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.
Self-guided internet-delivered cognitive behavior therapy for depression in adolescents
Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.
Treatment as usual (TAU)
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.
Treatment as usual
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.
Interventions
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Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents
Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.
Self-guided internet-delivered cognitive behavior therapy for depression in adolescents
Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.
Treatment as usual
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
* Stable medication with antidepressants, central stimulants and neuroleptics at least 6 weeks prior to inclusion.
* A minimum of one caregiver that is able to co-participate in the treatment.
Exclusion Criteria
* 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.
13 Years
17 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Eva Serlachius
PhD, MD
Principal Investigators
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Eva Serlachius, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Child and Adolescent Psychiatry Research Center
Stockholm, , Sweden
Countries
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References
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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.
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.
Other Identifiers
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2019-03235
Identifier Type: -
Identifier Source: org_study_id