Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

February 6, 2014 updated by: Gerhard Andersson, Linkoeping University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden
        • Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks pre treatment, two weeks post treatment, six months and 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.
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two weeks pre treatment, two weeks post treatment, six months and 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.
Two weeks pre treatment, two weeks post treatment, six months and 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.
Two weeks pre treatment, two weeks post treatment, six months and 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.
Two weeks pre treatment and at six months post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-PC-HH-KHL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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