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Completed

NCT Number: NCT01463020

Behavioural Activation-Based Treatment Administered Through Smartphone

The objective is to test the effects of a smartphone-delivered behavioural activation treatment. Also, a moderator analysis of low and high severity of depressive symptoms will be made. We expect the behavioural activation intervention to be superior to the mindfulness intervention for the participants suffering from high severity of depressive symptoms - and the mindfulness intervention to be better or at least as good as the behavioural activation intervention for the participants suffering from low severity of depressive symptoms.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Östergötland County, Sweden

About this study

Major depression is expected to be the disorder with the highest disease burden in high-income countries by the year 2030. The efficacy of behavioural activation in the treatment of major depressive disorders has been established in a number of studies over the last four decades. Furthermore, behavioural activation is an intervention that can largely benefit from the use of new mobile technologies (e.g. smartphones). One important feature of mobile technology is the possibility for the therapist to reach the patient between sessions and thus create direct incentives for behavioural activation in everyday life. Therefore, developing smartphone-based behavioural activation interventions might be a way to develop a cost-effective treatment for people suffering from major depressive disorders.

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 the Internet and a smartphone
  • 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

Smartphone delivered BA

Behavioral

A 8 week behavioural activation therapy delivered through smartphone

Smartphone delivered mindfulness

Other

A 8 week mindfulness intervention delivered through smartphone

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

Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2011
Registry last updated
Jun 19, 2013

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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