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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University | Linköping | Östergötland County | 58183 | Sweden |
De-identified individual participant data will be shared on request following initial publication of results.
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After the recruitment is finished, participants will be randomized to either ICBT treatment combined with a smartphone app or wait-list control condition.
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|
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. |
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. |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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