Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
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ClinicalTrials.gov Identifier: NCT01819025 |
Recruitment Status :
Completed
First Posted : March 27, 2013
Last Update Posted : February 7, 2014
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Condition or disease | Intervention/treatment | Phase |
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Depression | Behavioral: 4 face-to-face therapy session and a smartphone-app Behavioral: CBT, treatment as usual | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Face-to-face CBT Treatment of Depression With Smartphone Support |
Study Start Date : | March 2013 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
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Experimental: 4 face-to-face and smartphone-app
Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions.
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Behavioral: 4 face-to-face therapy session and a smartphone-app
An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application. |
Active Comparator: TAU
10 sessions of face-to-face therapy, full behavioral activation
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Behavioral: CBT, treatment as usual
10 sessions of face-to-face therapy, full behavioral activation |
- Patient Health Questionnaire (PHQ-9)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- Beck Depression Inventory (BDI)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- Quality of Life Inventory (QOLI)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- Acceptance & Action Questionnaire (AAQ)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- Beck Anxiety Inventory (BAI)- Change from baseline [ Time Frame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment ]Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
- Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline [ Time Frame: Two weeks pre treatment and at six months post treatment. ]Change from baseline in health cost burden and at six months post treatment.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819025
Sweden | |
Linköping University | |
Linköping, Östergötland, Sweden |
Responsible Party: | Gerhard Andersson, Professor, Linkoeping University |
ClinicalTrials.gov Identifier: | NCT01819025 |
Other Study ID Numbers: |
GA-PC-HH-KHL |
First Posted: | March 27, 2013 Key Record Dates |
Last Update Posted: | February 7, 2014 |
Last Verified: | July 2013 |
Depression Behavioral activation Smartphone application Face-to-face Blended therapy |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |