Behavioural Activation-Based Treatment Administered Through Smartphone

Study Overview
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Brief Summary
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The objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. We expect the behavioural activation intervention to be superior to the mindfulness intervention for the participants suffering from high severity of depressive symptoms - and the mindfulness intervention to be better or at least as good as the behavioural activation intervention for the participants suffering from low severity of depressive symptoms.

Detailed Description
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Major depression is expected to be the disorder with the highest disease burden in high-income countries by the year 2030. The efficacy of behavioural activation in the treatment of major depressive disorders has been established in a number of studies over the last four decades. Furthermore, behavioural activation is an intervention that can largely benefit from the use of new mobile technologies (e.g. smartphones). One important feature of mobile technology is the possibility for the therapist to reach the patient between sessions and thus create direct incentives for behavioural activation in everyday life. Therefore, developing smartphone-based behavioural activation interventions might be a way to develop a cost-effective treatment for people suffering from major depressive disorders.

Official Title
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Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Smartphone delivered BA
* Other: Smartphone delivered mindfulness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: depressive symptoms according to DSM-IV have access to the Internet and a smartphone have good knowledge of the Swedish language Exclusion Criteria: recent (during last 6 weeks) change in psychiatric medication presently in any other psychological treatment severe depression suicidal ideation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone delivered BA<br> | Behavioral: Smartphone delivered BA<br>* A 8 week behavioural activation therapy delivered through smartphone<br>|
| Active Comparator: Smartphone delivered mindfulness<br> | Other: Smartphone delivered mindfulness<br>* A 8 week mindfulness intervention delivered through smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9)- Change from baseline | Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment. | Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment | 
| Beck Depression Inventory (BDI)- Change from baseline | Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment. | Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Inventory (QOLI)- Change from baseline | Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment. | Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment | 
| Acceptance & Action Questionnaire (AAQ)- Change from baseline | Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment. | Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment | 
| Beck Anxiety Inventory (BAI)- Change from baseline | Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment. | Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment | 
| Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline | Change from baseline in health cost burden and at six months post treatment. | Two weeks pre treatment and at six months post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smartphone, Depression, Behavioural activation, Mindfulness