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Behavioural Activation-Based Treatment Administered Through Smartphone

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ClinicalTrials.gov Identifier: NCT01463020
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Depression Behavioral: Smartphone delivered BA Other: Smartphone delivered mindfulness Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application
Study Start Date : February 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463020


Locations
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Sweden
Linköping University
Linköping, Östergötland, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
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Study Director: Gerhard Andersson, Professor Linkoeping University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01463020    
Other Study ID Numbers: GA-PC-KHL
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by Gerhard Andersson, Linkoeping University:
Depression
Smartphone
Behavioural activation
Mindfulness
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms