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Completed

NCT Number: NCT01819025

Cognitive Behavioral Therapy 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 face-to-face therapy session and a smartphone-app

Behavioral

An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.

CBT, treatment as usual

Behavioral

10 sessions of face-to-face therapy, full behavioral activation

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Face-to-face CBT Treatment of Depression With Smartphone Support

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 27, 2013
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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