Depressive SymptomsFIGNCT06907134
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
A study testing Smartphone delivered internet-based Cognitive Behavioural Therapy in people with Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Smartphone delivered internet-based Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 2 Nov 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Smartphone delivered internet-based Cognitive Behavioural Therapy
- Keywords
- depressive symtoms, smartphone app, mobile game, internet-based cognitive behavioural therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone delivered internet-based Cognitive Behavioural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone delivered Internet-based Cognitive Behavioural Therapy | Experimental | The treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand. Receives: Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy |
| No Intervention: Wait-list control condition | No intervention | Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
Secondary outcomes (2)
Generalized Anxiety Disorder-7
Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptom
Measured: 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
Measured: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start2 Nov 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the recruitment is finished, participants will be randomized to either ICBT treatment combined with a smartphone app or wait-list control condition.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907134
- Sponsor's protocol ID
- FIG
- Acronym
- FIG
- Status last verified
- Nov 2025
- First submitted
- 20 Dec 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared on request following initial publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Smartphone-delivered Cognitive Behavioral Therapy for Adults Treated With Medication for Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06907134
- Acronym / sponsor ID
- FIG / FIG
- Conditions
- Depressive Symptoms
- Keywords
- depressive symtoms, smartphone app, mobile game, internet-based cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the recruitment is finished, participants will be randomized to either ICBT treatment combined with a smartphone app or wait-list control condition.
| Arm | Type | Receives |
|---|---|---|
| Smartphone delivered Internet-based Cognitive Behavioural Therapy | Experimental | Behavioral: Smartphone delivered internet-based Cognitive Behavioural TherapyThe treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand. |
| No Intervention: Wait-list control condition | No intervention | –Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone delivered internet-based Cognitive Behavioural TherapyThe 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. | Behavioural | Smartphone delivered Internet-based Cognitive Behavioural Therapy |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared on request following initial publication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone delivered internet-based Cognitive Behavioural Therapy in people with Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.