Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Tracking Information
First Submitted Date ICMJE	March 22, 2013
First Posted Date ICMJE	March 27, 2013
Last Update Posted Date	February 7, 2014
Study Start Date ICMJE	March 2013
Actual Primary Completion Date	January 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 26, 2013)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01819025 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 26, 2013)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Official Title ICMJE	Face-to-face CBT Treatment of Depression With Smartphone Support
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Depression
Intervention ICMJE	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.; Behavioral: CBT, treatment as usual 10 sessions of face-to-face therapy, full behavioral activation
Study Arms	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. Intervention: Behavioral: 4 face-to-face therapy session and a smartphone-app; Active Comparator: TAU 10 sessions of face-to-face therapy, full behavioral activation Intervention: Behavioral: CBT, treatment as usual
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 6, 2014)	88
Original Estimated Enrollment ICMJE; (submitted: March 26, 2013)	100
Actual Study Completion Date	January 2014
Actual Primary Completion Date	January 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Sweden
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01819025
Other Study ID Numbers ICMJE	GA-PC-HH-KHL
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gerhard Andersson, Linkoeping University
Study Sponsor ICMJE	Linkoeping University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Linkoeping University
Verification Date	July 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP