Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

Detailed Description
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Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades. Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions. Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.

Official Title
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Face-to-face CBT Treatment of Depression With Smartphone Support

Conditions
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Depression

Intervention / Treatment
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* Behavioral: 4 face-to-face therapy session and a smartphone-app
* Behavioral: CBT, treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: depressive symptoms according to DSM-IV have access to a smartphone and to the Internet 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

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: 4 face-to-face and smartphone-app<br>Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions. | Behavioral: 4 face-to-face therapy session and a smartphone-app<br>* An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.<br>|
| Active Comparator: TAU<br>10 sessions of face-to-face therapy, full behavioral activation | Behavioral: CBT, treatment as usual<br>* 10 sessions of face-to-face therapy, full behavioral activation<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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Depression, Behavioral activation, Smartphone application, Face-to-face, Blended therapy