Condition category
Mental and Behavioural Disorders
Date applied
20/12/2018
Date assigned
25/01/2019
Last edited
20/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The need of development of early, short and focused interventions for depressed adolescents is urgent. Internet-based interventions are designed to increase access to psychological treatments and cost-effectiveness. Empirical support is already established for Internet-based cognitive behavioural therapy (I-CBT) with response rate of about 60 %. In the present study, the aim is to test the feasibility and efficacy of a recently developed internet-based treatment for depressed adolescents – internet-delivered psychodynamic therapy (I-PDT).

Who can participate?
Adolescents aged 15-18 years with mild to moderate depression will be included.

What does the study involve?
The study is a randomized controlled trial for 72 participants, in which half of the participants will begin treatment immediately after inclusion and the other half will receive a brief supportive contact until they receive the treatment 10 weeks after inclusion. The interventions consist of 8 therapist-supported self-help modules delivered over 8 weeks with added chat sessions. Primary outcome will be severity of depressive symptoms. Secondary outcomes will be anxiety symptoms and psychiatric diagnoses. The aim of I-PDT is to decrease emotional avoidance and increase awareness and experience of emotions. Participants are encouraged to gradually approach previously warded off feelings. They will also be taught how to link their emotions to their symptoms. Another treatment goal is to acquire a greater capacity for anxiety regulation.

What are the possible benefits and risks of participating?
The expected benefit of the treatment is that it will reduce depressive symptoms among the participants. Internet-based treatments bear the possibility to reach depressed adolescents who do not have access to adequate psychological treatment, for example due to geographical reasons, or are reluctant to seek face-to-face treatment within the health care system. Psychological treatments are based on the fact that participants share very personal information and there is a risk that some participants might experience this as a threat to their integrity. The project will use established strategies to manage other types of risks, for example that some participants turns out having more serious medical, psychological or social problems than was discovered at inclusion.

Where is the study run from?
Department of Psychology, Stockholm University, Sweden.

When is the study starting and how long is it expected to run for?
This trial is a pilot study that will start in 3 January, 2019, and run until 30 June, 2019. The pilot study is the first part of a larger project and the next step will be a large non-inferiority randomized controlled trial investigating comparative effects between I-PDT and an already established internet based treatment (I-CBT) for adolescents.

Who is funding the study?
The project has received funding from the Kavli Trust for the years 2019-2023.

Who is the main contact?
Main contact is principal investigator Björn Philips, Associative Professor, at the Department of Psychology, Stockholm University, Sweden.

Trial website

https://erica.nu

Contact information

Type

Scientific

Primary contact

Dr Björn Philips

ORCID ID

Contact details

Department of Psychology
Stockholm University
Stockholm
SE-106 91
Sweden
+46 8 162010
bjorn.philips@psychology.su.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018/2268-31/5

Study information

Scientific title

ERiCA I-PDT for depressed adolescents – a pilot randomized controlled trial

Acronym

ERiCA

Study hypothesis

Internet-delivered psychodynamic therapy (I-PDT) is more effective than symptom monitoring and brief support via internet with regard to reducing depressive symptoms.

Ethics approval

The Regional Ethical Board in Stockholm, 13/12/2018, ref. 2018/2268-31/5.

Study design

Interventional, randomized controlled trial, pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Mild to moderate depression in adolescents

Intervention

Directly after inclusion, participants will be randomized to one of two arms with 1:1 ratio: intervention or control condition. An independent researcher, not involved in the study, will conduct the randomisation procedure by means of a computerised random number service.

Intervention: Internet-delivered psychodynamic treatment (I-PDT) that consists of 8 therapist-supported self-help modules delivered over 8 weeks in a secure online platform. Modules consist of texts followed by assignments which they send to their therapist and receive feedback within a few days, complemented with 30 minutes chat support weekly. The aim of I-PDT is to decrease emotional avoidance and increase awareness and experience of emotions. Participants are encouraged to gradually approach previously warded off feelings. They will also be taught how to link their emotions to their symptoms. Another treatment goal is to acquire a greater capacity for anxiety regulation. Treatment duration is 8 weeks and measurements are made prior to treatment, weekly during treatment, and at termination.

Control condition: Brief supportive contact over internet over 8 weeks, with monitoring of symptoms and well-being as well as exchange of short messages between participant and therapist. Duration is 8 weeks and measurements are made prior to the supportive contact, weekly during the supportive contact, and at termination. After 10 weeks, participants in the control condition will be offered the I-PDT-program with email-support. New measurements will be made weekly during the treatment and at termination.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Depressive symptoms will be measured using the Quick Inventory of Depressive Symptomatology in Adolescents (Bernstein et al., 2010) via internet delivered self-rating forms pre-treatment, weekly during treatment and post-treatment.
1.1. In order to fully explore trajectories of change and possible moderating and mediating factors over time, a parallel process latent growth curve strategy will be employed.
2. Differences in efficacy between conditions will be investigated by modelling interaction effects of group and time.

Secondary outcome measures

1. Anxiety symptoms will be measured weekly using the Generalised Anxiety Disorder 7- item scale (GAD-7; Kroenke et al., 2010).
2. The severity of depression symptoms will be measured pre- and post-treatment using the Montgomery Åsberg Depression Rating Scale (Svanborg & Åsberg, 1994).

Overall trial start date

01/11/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adolescents 15-18 years of age
2. Suffering from mild to moderate symptoms of depression according to 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.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

72

Total final enrolment

76

Participant exclusion criteria

1. Risk of suicidality and/or earlier suicide attempts,
2. Partaking in other psychological treatment,
3. Psychotropic medication not stable since at least three months,
4. Other primary diagnoses in need of other treatment
5. Current fulfillment of any of the following diagnoses: any psychotic disorder, bipolar I/II disorder, antisocial personality disorder, and autism-spectrum disorder.
6. Comorbid drug or alcohol abuse.

Recruitment start date

03/01/2019

Recruitment end date

01/02/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Psychology, Stockholm University
Department of Psychology, Stockholm University
Stockholm
SE-106 91
Sweden

Sponsor information

Organisation

Department of Psychology, Stockholm University

Sponsor details

Department of Psychology
Stockholm University
Stockholm
SE-106 91
Sweden

Sponsor type

University/education

Website

https://www.psychology.su.se/

Funders

Funder type

Charity

Funder name

Kavli Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The primary outcome paper will present outcome data in a journal with open access publication, with preliminary time-point for publication in October 2019. Data that break the blind will not be presented prior to the release of mainline results. No outcome data will be published or presented before data collection is completed. The results will also be disseminated in popular science form through different media, partly with help of the user representatives from Suicide Zero.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

15/10/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/03/2019: The following changes have been made. 1. The total final enrolment number has been added. 2. The overall trial end date has been changed from 30/06/2019 to 31/12/2020. 31/01/2019: The recruitment end date was changed from 25/01/2019 to 01/02/2019.