Clinical trial NCT01463020: Behavioural Activation-Based Treatment Administered Through Smartphone
Official title: Behavioural Activation-Based Guided Self-Help Treatment Administered Through a Smartphone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Smartphone
Behavioural activation
Mindfulness
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2011-11-01
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Beck Depression Inventory (BDI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes:
measure: Quality of Life Inventory (QOLI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Acceptance & Action Questionnaire (AAQ)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Beck Anxiety Inventory (BAI)- Change from baseline
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
timeFrame: Two weeks pre treatment and at six months post treatment.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_DIRECTOR
References:
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.
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.