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The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition (FIG)

L

Linköping University (LiU)

Status

Active, not recruiting

Conditions

Depressive Symptoms

Treatments

Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.

Full description

This study is a randomized controlled trial with the aim to investigate if an smartphone app in combination with ICBT can help adults (+18) on antidepressant medication who still suffers from depressive symptoms. Participants will either be randomized to a treatment phase for 9 weeks or to a wait-list control. The treatment primarily contains the installation and usage of a smartphone app where the participants can engage in a serious mobile game based on CBT-principles. They will receive access to a secure internet platform where they can find general guidelines about the app, and extra treatment modules (to use if needed). They will receive support on demand from a therapist during the whole treatment period.

Primary outcome measure is depressive symptoms (measured on the MADRAS scale). Secondary outcome measures will include measures of anxiety and quality of life. Pre-treatment measurement, post-treatment measurement, weekly measure, and 24 & 36 months follow up is planned to be collected through an online survey.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care.
  • 18 years or older.
  • Be able to speak, read and write Swedish.
  • Have access to a computer, tablet or other device with internet connection and smartphone to download the app.

Exclusion criteria

  • Severe psychiatric or somatic problems that make participation difficult or impossible
  • Ongoing abuse (via Audit and during interview)
  • Acute suicidality
  • Other ongoing psychological treatment or planned investigation.
  • Planned dose change of medicine or change of medicine during pre-measurement.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Smartphone delivered Internet-based Cognitive Behavioural Therapy
Experimental group
Description:
The treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand.
Treatment:
Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy
No Intervention: Wait-list control condition
No Intervention group
Description:
Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.

Trial contacts and locations

1

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Central trial contact

Gerhard Andersson, PhD; Matilda Berg, PhD

Data sourced from clinicaltrials.gov

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