Clinical trial 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
Official title: A Controlled Trial of Smartphone-delivered Cognitive Behavioral Therapy for Adults Treated With Medication for Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: depressive symtoms
smartphone app
mobile game
internet-based cognitive behavioural therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2025-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg Depression Ranging Scale (MADRS)
timeFrame: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
Secondary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
measure: Brunnsviken Brief Quality of life scale
timeFrame: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
Other outcomes:
measure: Patient Health Questionnaire - 4
timeFrame: From enrollment on a weekly basis through study completion 9 weeks later.
measure: Client Satisfaction Questionnaire
timeFrame: At week 9 following enrollment.
measure: The Morisky Medication Adherence Scale
timeFrame: From enrollment to end of treament at 9 weeks.
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
References: