Behavioural Activation-Based Treatment Administered Through Smartphone
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Smartphone delivered BA
Smartphone delivered mindfulness
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Smartphone, Behavioural activation, Mindfulness
Eligibility 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
Sites / Locations
- Linköping University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smartphone delivered BA
Smartphone delivered mindfulness
Arm Description
Outcomes
Primary Outcome Measures
Patient Health Questionnaire (PHQ-9)- Change from baseline
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
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
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
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
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
Change from baseline in health cost burden and at six months post treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01463020
Brief Title
Behavioural Activation-Based Treatment Administered Through Smartphone
Official Title
Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Smartphone, Behavioural activation, Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone delivered BA
Arm Type
Experimental
Arm Title
Smartphone delivered mindfulness
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Smartphone delivered BA
Intervention Description
A 8 week behavioural activation therapy delivered through smartphone
Intervention Type
Other
Intervention Name(s)
Smartphone delivered mindfulness
Intervention Description
A 8 week mindfulness intervention delivered through smartphone
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Beck Depression Inventory (BDI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary Outcome Measure Information:
Title
Quality of Life Inventory (QOLI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Acceptance & Action Questionnaire (AAQ)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Beck Anxiety Inventory (BAI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
Description
Change from baseline in health cost burden and at six months post treatment.
Time Frame
Two weeks pre treatment and at six months post treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24413342
Citation
Ly KH, Truschel A, Jarl L, Magnusson S, Windahl T, Johansson R, Carlbring P, Andersson G. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial. BMJ Open. 2014 Jan 9;4(1):e003440. doi: 10.1136/bmjopen-2013-003440.
Results Reference
derived
PubMed Identifier
22607302
Citation
Ly KH, Carlbring P, Andersson G. Behavioral activation-based guided self-help treatment administered through a smartphone application: study protocol for a randomized controlled trial. Trials. 2012 May 18;13:62. doi: 10.1186/1745-6215-13-62.
Results Reference
derived
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Behavioural Activation-Based Treatment Administered Through Smartphone
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