NCT01463020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

October 28, 2011

Last Update Submit

June 18, 2013

Conditions

Depression

Keywords

DepressionSmartphoneBehavioural activationMindfulness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Quality of Life Inventory (QOLI)- Change from baseline

    Two weeks pre treatment, two weeks post treatment, six months and 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

  • Beck Anxiety Inventory (BAI)- Change from baseline

    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

    Two weeks pre treatment and at six months post treatment.

Study Arms (2)

Smartphone delivered BA

EXPERIMENTAL
Behavioral: Smartphone delivered BA

Smartphone delivered mindfulness

ACTIVE COMPARATOR
Other: Smartphone delivered mindfulness

Interventions

Smartphone delivered BABEHAVIORAL

A 8 week behavioural activation therapy delivered through smartphone

Smartphone delivered BA
Smartphone delivered mindfulnessOTHER

A 8 week mindfulness intervention delivered through smartphone

Smartphone delivered mindfulness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • depressive symptoms according to DSM-IV
  • have access to the Internet and a smartphone
  • have good knowledge of the Swedish language

You may not qualify if:

  • recent (during last 6 weeks) change in psychiatric medication
  • presently in any other psychological treatment
  • severe depression
  • suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, Östergötland County, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 24413342DERIVED

  • 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.

    PMID: 22607302DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gerhard Andersson, Professor

    Linkoeping University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 1, 2011

Study Start

February 1, 2012

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

SE(1)