Behavioural Activation-Based Treatment Administered Through Smartphone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01463020
First received: October 28, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Smartphone delivered BA
Other: Smartphone delivered mindfulness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application

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: 81
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smartphone delivered BA Behavioral: Smartphone delivered BA
A 8 week behavioural activation therapy delivered through smartphone
Active Comparator: Smartphone delivered mindfulness Other: Smartphone delivered mindfulness
A 8 week mindfulness intervention delivered through smartphone

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01463020

Locations
Sweden
Linköping University
Linköping, Östergötland, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
Study Director: Gerhard Andersson, Professor Linköping university
  More Information

No publications provided by Linkoeping University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01463020     History of Changes
Other Study ID Numbers: GA-PC-KHL
Study First Received: October 28, 2011
Last Updated: June 18, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Depression
Smartphone
Behavioural activation
Mindfulness

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014