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

Sponsor:

Information provided by (Responsible Party):

Gerhard Andersson, Linkoeping University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: 4 face-to-face therapy session and a smartphone-app Behavioral: CBT, treatment as usual	Not Applicable

Detailed Description:

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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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	Behavioral: CBT, treatment as usual 10 sessions of face-to-face therapy, full behavioral activation

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Sweden
Linköping University
Linköping, Östergötland, Sweden

Sponsors and Collaborators

Linkoeping University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ly KH, Topooco N, Cederlund H, Wallin A, Bergström J, Molander O, Carlbring P, Andersson G. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial. PLoS One. 2015 May 26;10(5):e0126559. doi: 10.1371/journal.pone.0126559. eCollection 2015.


Responsible Party:	Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier:	NCT01819025 History of Changes
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

Keywords provided by Gerhard Andersson, Linkoeping University:


Depression Behavioral activation Smartphone application Face-to-face Blended therapy

Additional relevant MeSH terms:


Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders

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