Behavioural Activation-Based Treatment Administered Through Smartphone

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT01463020
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-01
• Study Start: 2012-02
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)- Change from baseline	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.
Beck Depression Inventory (BDI)- Change from baseline	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

Name	Time	Method
Quality of Life Inventory (QOLI)- Change from baseline	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.
Acceptance & Action Questionnaire (AAQ)- Change from baseline	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.
Beck Anxiety Inventory (BAI)- Change from baseline	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.
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline	Two weeks pre treatment and at six months post treatment.	Change from baseline in health cost burden and at six months post treatment.

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Östergötland, Sweden