Behavioural Activation-Based Treatment Administered Through Smartphone

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Smartphone delivered BA; Other: Smartphone delivered mindfulness

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden
      • Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone delivered BA	Behavioral: Smartphone delivered BA; A 8 week behavioural activation therapy delivered through smartphone
Active Comparator: Smartphone delivered mindfulness	Other: Smartphone delivered mindfulness; A 8 week mindfulness intervention delivered through smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Director: Gerhard Andersson, Professor, Linkoeping University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Depression; Mindfulness; Smartphone; Behavioural activation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: GA-PC-KHL