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Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
4 face-to-face therapy session and a smartphone-app
CBT, treatment as usual
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Behavioral activation, Smartphone application, Face-to-face, Blended therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Linköping University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 face-to-face and smartphone-app

TAU

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 22, 2013
Last Updated
February 6, 2014
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01819025
Brief Title
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Official Title
Face-to-face CBT Treatment of Depression With Smartphone Support
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Mild to moderate depression is a major health problem, which lowers the quality of life for the individual and generates enormous costs for society. Several forms of psychotherapy have been found to be effective in the treatment of depression. Among these, behavioral activation has a strong empirical base. The efficacy of behavioral activation for treating major depressive disorders has been established in a number of studies over the last four decades. Moreover face-to-face treatments could benefit from using smartphones as an adjunct to the regular sessions, which in the case of behavioral activation treatments for depression could facilitate activity scheduling and homework, which are crucial elements of the treatment. It may also be possible to reduce the number of sessions. Since it has been shown that full behavioral activation is an effective treatment for mild to moderate depression, this study will be designed as a so-called non-inferiority study in which the treatment group, given fewer meetings face-to-face, but instead support in the form of a smartphone application. Instead of a traditional behavioral activation treatment of 10 sessions, the treatment group will be given four face-to-face CBT sessions and a smartphone app as a complement and support to the four sessions. As a control, the investigators will give full behavioral activation with 10 sessions of face-to-face therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Behavioral activation, Smartphone application, Face-to-face, Blended therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 face-to-face and smartphone-app
Arm Type
Experimental
Arm Description
Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions.
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
10 sessions of face-to-face therapy, full behavioral activation
Intervention Type
Behavioral
Intervention Name(s)
4 face-to-face therapy session and a smartphone-app
Intervention Description
An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.
Intervention Type
Behavioral
Intervention Name(s)
CBT, treatment as usual
Intervention Description
10 sessions of face-to-face therapy, full behavioral activation
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Beck Depression Inventory (BDI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary Outcome Measure Information:
Title
Quality of Life Inventory (QOLI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Acceptance & Action Questionnaire (AAQ)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Beck Anxiety Inventory (BAI)- Change from baseline
Description
Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Time Frame
Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Title
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline
Description
Change from baseline in health cost burden and at six months post treatment.
Time Frame
Two weeks pre treatment and at six months post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: depressive symptoms according to DSM-IV have access to a smartphone and to the Internet 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
Facility Information:
Facility Name
Linköping University
City
Linköping
State/Province
Östergötland
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26010890
Citation
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.
Results Reference
derived

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Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

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