Administrative information
Title {1} | Internet-based psychodynamic therapy versus cognitive behaviour therapy for adolescents with depression: Study protocol for a non-inferiority randomized controlled trial (the ERiCA study) |
Trial registration {2a and 2b}. | The trial was prospectively registered in the World Health Organization’s International Clinical Trials Registry Platform (ISRCTN, identification number 12552584). Registered 13 August 2019, https://www.isrctn.com/ISRCTN12552584 |
Protocol version {3} | 2/18/20, version 1 5/20/20, version 2 |
Funding {4} | The project is co-funded by the Kavli Trust (grant no. 32/18) and the Department of Psychology, Stockholm University. |
Author details {5a} | Jakob Mechler, MSc, Department of Psychology, Stockholm University, Stockholm, Sweden, jakob.mechler@psychology.su.se Karin Lindqvist, MSc, Department of Psychology, Stockholm University, Stockholm, Sweden, karin.lindqvist@psychology.su.se, Per Carlbring, Ph.D., Department of Psychology, Stockholm University, Stockholm, Sweden, per.carlbring@psychology.su.se Peter Lilliengren, PhD, Ersta Sköndal Bräcke University College, Stockholm, Sweden, peter.lilliengren@esh.se Fredrik Falkenström, PhD, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden, fredrik.falkenstrom@liu.se Gerhard Andersson, PhD, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden, gerhard.andersson@liu.se Naira Topooco, PhD, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden; Center for m2Health, Palo Alto, CA, United States, Naira.topooco@liu.se Robert Johansson, PhD, Department of Psychology, Stockholm University, Stockholm, Sweden, robert.johansson@psychology.su.se Nick Midgley, PsychD PhD, Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families/University College London, UK, nick.midgley@annafreud.org Julian Edbrooke-Childs, PhD, Department of Clinical, Educational and Health Psychology, University College London; Evidence Based Practice Unit, Anna Freud National Centre for Children and Families, London, UK, Julian.Childs@annafreud.org Hanne-Sofie J Dahl, PhD, Vestfold Hospital Trust; Department of Psychology, University of Oslo, h.s.j.dahl@psykologi.uio.no Rolf Sandell, PhD, Department of Psychology, Lund University, Lund, Sweden, rolf.sandell@psy.lu.se Agneta Thorén, PhD, The Erica Foundation, Stockholm, Sweden, agneta.thoren@ericastiftelsen.se Randi Ulberg, PhD MD, University of Oslo, Oslo, Norway, randi.ulberg@medisin.uio.no Katja Lindert Bergsten, PhD, Department of Psychology, Uppsala University, Uppsala, Sweden, katja.bergsten@psyk.uu.se Björn Philips, PhD, Department of Psychology, Stockholm University, Stockholm, Sweden, Bjorn.philips@psychology.su.se (corresponding author) |
Name and contact information for the trial sponsor {5b} | Department of Psychology, Stockholm University, SE-106 91 Stockholm, Sweden |
Role of sponsor {5c} | The study PI, the project coordinators and several other members of the research group are employed by the sponsor Department of Psychology, Stockholm University. The PI and project coordinators are responsible for collection and management of data. The entire research group will be involved in analysis and interpretation of data, as well as writing of the report. The PI makes the decision to submit the report for publication, and all authors will approve the submitted manuscript. The co-funders, the Kavli Trust, has no part in study design, collection, management, analysis/interpretation of data, writing of the report or decision to submit the report for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Primary research question/primary outcome
Secondary research questions/secondary outcomes
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Therapists
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
IPDT
ICBT
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Outcomes {12}
Plans for assessment and collection of outcomes {18a}
Activity/assessment | Online screening/baseline | Telephone interview | Post-randomization | Follow-up | |||
---|---|---|---|---|---|---|---|
− t1 | t0 | t1–10 (weekly) | t11 (post) | f1 | f2 | f3 | |
Informed consent | X | ||||||
Demographic data | X | ||||||
ICBT/IPDT | X | ||||||
M.I.N.I 7.0 | X | ||||||
C-SSRS | X | ||||||
DSRFI | X | ||||||
Treatment Expectancya | X | X | |||||
QIDS-A17-SR | X | X | X | X | X | X | |
SAI-C/SAI-T | X | ||||||
GAD-7 | X | X | X | X | X | ||
SCS-SF | X | X | |||||
PID-5-BF | X | ||||||
TiC-P | X | X | |||||
ERSQ-27 | X | X | |||||
ERSQ-9 | X | ||||||
ECR-RS | X | ||||||
OPD-SQS | X | ||||||
Termination form | X |