Major depressive disorder in adolescents Mental and Behavioural Disorders
Conditions
Interventions
Immediately following inclusion, participants will be randomised to one of two arms with 1:1 ratio: I-PDT or I-CBT. An independent researcher, not involved in the study, will conduct the randomisation
Sponsors
Stockholm University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adolescents aged 15-19 years 2. Suffering from major depressive disorder as primary diagnosis according to DSM-5 as established through a diagnostic interview (MINI 7.0) 3. Have access to a computer/smartphone/tablet with internet connection 4. Able to read, write and speak Swedish without the aid of an interpreter
Exclusion criteria
Exclusion criteria: 1. Risk of suicidality and/or previous suicide attempts 2. Partaking in other psychological treatment 3. Psychotropic medication not stable for at least 1 month 4. Primary diagnoses other than MDD 5. Current fulfilment of any of the following diagnoses: any psychotic disorder, bipolar I/II disorder, antisocial personality disorder, or autism-spectrum disorder 6. Comorbid drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Depressive symptoms measured using the Quick Inventory of Depressive Symptomatology in Adolescents (QIDS; Bernstein et al., 2010) via internet-delivered self-rating forms pre-treatment, weekly during treatment and post-treatment (within 2 weeks of end of treatment). Differences in efficacy between conditions will be investigated by growth curve analysis using data from all measurement points. The non-inferiority margin is defined as Cohen’s d=.30. If the non-inferiority hypothesis is falsified, analysis of superiority will follow. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety symptoms measured pre- and post-treatment (within 2 weeks of end of treatment) using the Generalised Anxiety Disorder 7- item scale (GAD-7; Kroenke et al., 2010) 2. Anxiety symptoms measured using the GAD-7 scale at 1, 6, and 12 months post-treatment 3. Depression symptoms measured using QIDS at 1, 6, and 12 months post-treatment 4. Emotion regulation and self-compassion measured pre- and post-treatment (within 2 weeks of end of treatment) through the Emotion Regulation Skills Questionnaire (ERSQ; Grant, Salsman & Berking, 2018) and Self-Compassion Scale short-form (SCS-SF; Raes, Pommier, Neff & Van Gucht, 2011) 5. Cost-effectiveness of treatments evaluated with the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P; Bouwmans et al, 2013), pre-treatment and at 12-month follow-up. In line with recommendations for assessing cost-effectiveness in treatments of adolescents (Goorden, van der Schee, Hendriks, & Hakkaart van Roijen, 2016), only the sections of TIC-P regarding health care use will be administered. 5. Possible moderators for outcome will be analysed using the following measures pre-treatment, weekly during treatment and post-treatment (within 2 weeks of end of treatment): Experience in Close Relationships – Relationships Structure (ECR-RS; Feddern, Donbaek & Elklit, 2014); Operationalized Psychodynamic Diagnosis-Structure Questionnaire Short-form (OPD-SQS; Ehrenthal, Dinger, Schauenburg, Horsch, Dahlbender & Gierk, 2015), single item expectancy measure (adapted from Moras & Jones 1992 in Connolly Gibbons et al., 2003) and The Personality Inventory for DSM Short Form (PID-5; Krueger, Derringer, Markon, Watson & Skodol, 2013); SCS-SF (Raes, Pommier, Neff, & Van Gucht, 2011) 6. Possible mediators (and moderators) for outcome will be analysed using the following measures: Emotion Regulation Skills Questionnaire 9 | — |
Countries
Sweden
Outcome results
None listed