Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: 4 face-to-face therapy session and a smartphone-app; Behavioral: CBT, treatment as usual

• Registration Number: NCT01819025
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Status Verified: 2013-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 face-to-face and smartphone-app	4 face-to-face therapy session and a smartphone-app	Four face-to-face therapy sessions and smartphone app as a complement and support to the four sessions.
TAU	CBT, treatment as usual	10 sessions of face-to-face therapy, full behavioral activation

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)- Change from baseline	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Patient Health Questionnaire (PHQ-9)- Change from baseline	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.

Secondary Outcome Measures

Name	Time	Method
Acceptance & Action Questionnaire (AAQ)- Change from baseline	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	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	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	Change from baseline in anxiety symptoms two weeks post treatment, at six months and at 12 months post treatment.
Quality of Life Inventory (QOLI)- Change from baseline	Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment	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	Two weeks pre treatment and at six months post treatment.	Change from baseline in health cost burden and at six months post treatment.

Trial Locations

Locations (1)

Linköping University; 🇸🇪 Linköping, Östergötland, Sweden