NCT01819025

Brief Summary

The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable depression

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

Study Start

First participant enrolled

March 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 7, 2014

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

March 22, 2013

Last Update Submit

February 6, 2014

Conditions

Depression

Keywords

DepressionBehavioral activationSmartphone applicationFace-to-faceBlended therapy

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)

4 face-to-face and smartphone-app

EXPERIMENTAL

Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions.

Behavioral: 4 face-to-face therapy session and a smartphone-app

TAU

ACTIVE COMPARATOR

10 sessions of face-to-face therapy, full behavioral activation

Behavioral: CBT, treatment as usual

Interventions

4 face-to-face therapy session and a smartphone-appBEHAVIORAL

An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.

4 face-to-face and smartphone-app
CBT, treatment as usualBEHAVIORAL

10 sessions of face-to-face therapy, full behavioral activation

TAU

Eligibility Criteria

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

You may qualify if:

  • depressive symptoms according to DSM-IV
  • have access to a smartphone and to the Internet
  • 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 (1)

  • Ly KH, Topooco N, Cederlund H, Wallin A, Bergstrom J, Molander O, Carlbring P, Andersson G. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial. PLoS One. 2015 May 26;10(5):e0126559. doi: 10.1371/journal.pone.0126559. eCollection 2015.

    PMID: 26010890DERIVED

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

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

March 22, 2013

First Posted

March 27, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 7, 2014

Record last verified: 2013-07

Locations

SE(1)