Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01819025
First received: March 22, 2013
Last updated: February 6, 2014
Last verified: July 2013

March 22, 2013
February 6, 2014
March 2013
January 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Same as current
Complete list of historical versions of study NCT01819025 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Change from baseline in health cost burden and at six months post treatment.
Same as current
Not Provided
Not Provided
 
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Face-to-face CBT Treatment of Depression With Smartphone Support

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01819025
GA-PC-HH-KHL
No
Gerhard Andersson, Linkoeping University
Linkoeping University
Not Provided
Not Provided
Linkoeping University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP