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

Not Applicable

Active, not recruiting

• Conditions: Depressive Symptoms

• Registration Number: NCT06907134
• Lead Sponsor: Linkoeping University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-02
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-02
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Ranging Scale (MADRS)	From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.	MADRS-S is a questionnaire including nine questions about depressive mental states. The questions aslo address experienced worry, ability to concentrate and initiative. Each question gives between 0 and 6 points. Maximum score is 54 points. Higher scores indicate higher levels of depression.

Secondary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder-7	From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.	Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptom
Brunnsviken Brief Quality of life scale	From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.	Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Östergötland, Sweden