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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Linköping University
Linköping, Östergötland County, Sweden
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.
Time frame: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
Generalized Anxiety Disorder-7
Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptom
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
Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life
Time frame: From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.
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