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Behavioural Activation-Based Treatment Administered Through Smartphone

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01463020
Enrollment
81
Registered
2011-11-01
Start date
2012-02-29
Completion date
2013-05-31
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, Smartphone, Behavioural activation, Mindfulness

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.

Interventions

BEHAVIORALSmartphone delivered BA

A 8 week behavioural activation therapy delivered through smartphone

A 8 week mindfulness intervention delivered through smartphone

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)- Change from baselineTwo weeks pre treatment, two weeks post treatment, six months and 12 months post treatmentChange from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Beck Depression Inventory (BDI)- Change from baselineTwo weeks pre treatment, two weeks post treatment, six months and 12 months post treatmentChange from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.

Secondary

MeasureTime frameDescription
Quality of Life Inventory (QOLI)- Change from baselineTwo weeks pre treatment, two weeks post treatment, six months and 12 months post treatmentChange from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Acceptance & Action Questionnaire (AAQ)- Change from baselineTwo weeks pre treatment, two weeks post treatment, six months and 12 months post treatmentChange from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Beck Anxiety Inventory (BAI)- Change from baselineTwo weeks pre treatment, two weeks post treatment, six months and 12 months post treatmentChange 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 baselineTwo weeks pre treatment and at six months post treatment.Change from baseline in health cost burden and at six months post treatment.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026