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)

A Controlled Trial of Smartphone-delivered Cognitive Behavioral Therapy for Adults Treated With Medication for Depressive Symptoms

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Symptoms
• Intervention / Treatment: Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 58183
      • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone delivered Internet-based Cognitive Behavioural Therapy; The treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand.	Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy; The intervention is 9 week long were partipants use an smartphone app based on CBT-principles with while having access to an internet platform where extra working material and therapist support is available on demand.
No Intervention: No Intervention: Wait-list control condition; Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Asberg Depression Ranging Scale (MADRS)	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.	From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire - 4	Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.	From enrollment on a weekly basis through study completion 9 weeks later.
Client Satisfaction Questionnaire	CSQ is used to assess client satisfaction with health and human services. Total scores range from. 8 to 32, with the higher number indicating greater satisfaction.	At week 9 following enrollment.
The Morisky Medication Adherence Scale	The Morisky Medication Adherence Scale (MMAS-8) is an 8-item structured, self-report measure that assesses medication adherence. Higher scores indicates higher adherence	From enrollment to end of treament at 9 weeks.

Collaborators and Investigators

• Sponsor: Linkoeping University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: smartphone app; mobile game; depressive symtoms; internet-based cognitive behavioural therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: FIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared on request following initial publication of results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No