Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Face-to-face CBT Treatment of Depression With Smartphone Support

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: 4 face-to-face therapy session and a smartphone-app; Behavioral: CBT, 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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: 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.	Behavioral: 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.
Active Comparator: TAU; 10 sessions of face-to-face therapy, full behavioral activation	Behavioral: CBT, treatment as usual; 10 sessions of face-to-face therapy, full behavioral activation

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 6, 2014
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Depression; Smartphone application; Blended therapy; Behavioral activation; Face-to-face
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: GA-PC-HH-KHL