Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

NCT ID: NCT01819025

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4 face-to-face and smartphone-app

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

TAU

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

Group Type: ACTIVE_COMPARATOR

CBT, treatment as usual

Intervention Type: BEHAVIORAL

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

Interventions

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

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

Intervention Type: BEHAVIORAL

CBT, treatment as usual

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gerhard Andersson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Linköping University

Linköping, Östergötland County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 26010890 (View on PubMed)

Other Identifiers

GA-PC-HH-KHL

Identifier Type: -

Identifier Source: org_study_id