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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Face-to-face CBT Treatment of Depression With Smartphone Support

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

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 ] [ 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.


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 ] [ 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.


Enrollment: 88
Study Start Date: March 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819025

Locations
Sweden
Linköping University
Linköping, Östergötland, Sweden
Sponsors and Collaborators
Linkoeping University
  More Information

No publications provided

Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01819025     History of Changes
Other Study ID Numbers: GA-PC-HH-KHL
Study First Received: March 22, 2013
Last Updated: February 6, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014