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NCT Number: NCT06907134

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, 58183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone delivered internet-based Cognitive Behavioural Therapy

Behavioral

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.

Primary outcomes

  1. Montgomery Asberg Depression Ranging Scale (MADRS)

    Time frame: 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 outcomes

  1. Generalized Anxiety Disorder-7

    Time frame: 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

  2. Brunnsviken Brief Quality of life scale

    Time frame: 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

Other outcomes

  1. Patient Health Questionnaire - 4

    Time frame: From enrollment on a weekly basis through study completion 9 weeks later.

    Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.

  2. Client Satisfaction Questionnaire

    Time frame: At week 9 following enrollment.

    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.

  3. The Morisky Medication Adherence Scale

    Time frame: From enrollment to end of treament at 9 weeks.

    The Morisky Medication Adherence Scale (MMAS-8) is an 8-item structured, self-report measure that assesses medication adherence. Higher scores indicates higher adherence

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: FIG

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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