Behavioural Activation-Based Treatment Administered Through Smartphone

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463020
• Other study ID #: GA-PC-KHL
• Status: Completed
• Phase: N/A
• First received: October 28, 2011
• Last updated: June 18, 2013
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Smartphone delivered BA
A 8 week behavioural activation therapy delivered through smartphone

Other:
• Smartphone delivered mindfulness
A 8 week mindfulness intervention delivered through smartphone

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	Yes
Primary	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.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	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.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	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.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	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.	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	No
Secondary	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.	Two weeks pre treatment and at six months post treatment.	No