Clinical trial NCT04117789: Feasibility of Internet-delivered CBT for Adolescents With Depression
Official title: Feasibility of Internet-delivered Cognitive Behavior Therapy for Adolescents With Mild to Moderate Depression: A Randomized Pilot Study Comparing Therapist-guided vs. Self-guided ICBT vs. Treatment as Usual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A single-blind parallel-group pilot randomised controlled feasibility trial with the overall aim to develop two internet-delivered cognitive behaviour therapy interventions, therapist-guided and self-guided, for adolescents with mild to moderate Major Depressive Disorder (MDD) and their primary caregivers.

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.

Eligibility criteria: Inclusion Criteria:

* 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).
* 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:

* 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.

Primary outcomes:
measure: Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: week 0, week 10, at 3 months follow-up
Secondary outcomes:
measure: Treatment credibility and expectancy scale - adolescent and parent version
timeFrame: week 3
measure: The Client Satisfaction Questionnaire-8 (CSQ-8) - adolescent and parent version
timeFrame: week 10, at 3 months follow-up
measure: Need for further treatment - adolescent and parent version
timeFrame: week 10, at 3 months follow-up
measure: Negative Effects Questionnaire (NEQ-20) - adolescent and parent version
timeFrame: week 5, week 10, at 3 months-follow up
measure: Treatment completion
timeFrame: week 10
measure: Therapist time
timeFrame: week 1 to week 10
measure: Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: week 0, week 10, at 3 months follow-up
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: week 10, at 3 months follow-up
measure: Children's global assessment scale (CGAS)
timeFrame: week 0, week 10, at 3 months follow-up
measure: Short Mood and Feeling Questionnaire (SMFQ) - adolescent and parent version
timeFrame: week 0, weekly from week 1 to week 10, at 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 months follow-up
measure: Affective Reactivity Index (ARI) - adolescent and parent version
timeFrame: week 0, week 10, 3 months follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: week 0, week 10, at 3 months follow-up
measure: Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent version
timeFrame: week 0, week 10, 3 months follow-up
measure: Working Alliance Inventory, Short (WAI-S) - adolescent and parent version
timeFrame: week 10, 3 months follow-up
measure: Kidscreen-10 Index - adolescent and parent version
timeFrame: week 0, week 10, at 3 months follow-up
Other outcomes:
measure: Behavioral activation of Depression Scale - short form (BADS-S)
timeFrame: weekly during treatment (week 1 to week 10)
measure: Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
timeFrame: week 0, week 10, at 3 months follow-up
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry Research Center
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: