Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support

• ClinicalTrials.gov Identifier: NCT01819025
• Recruitment Status: Completed
• First Posted: March 27, 2013
• Last Update Posted: February 7, 2014
• Sponsor: Linkoeping University
• Information provided by (Responsible Party): Gerhard Andersson, Linkoeping University

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.

Condition or disease	Intervention/treatment	Phase
Depression	Behavioral: 4 face-to-face therapy session and a smartphone-app; Behavioral: CBT, treatment as usual	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Face-to-face CBT Treatment of Depression With Smartphone Support
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Patient Health Questionnaire (PHQ-9)- Change from baseline [ Time Frame: 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.
2. Beck Depression Inventory (BDI)- Change from baseline [ Time Frame: 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 :

1. Quality of Life Inventory (QOLI)- Change from baseline [ Time Frame: 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.
2. Acceptance & Action Questionnaire (AAQ)- Change from baseline [ Time Frame: 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.
3. Beck Anxiety Inventory (BAI)- Change from baseline [ Time Frame: 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.
4. Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)- Change from baseline [ Time Frame: Two weeks pre treatment and at six months post treatment. ]
   Change from baseline in health cost burden and at six months post treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Linköping University

Linköping, Östergötland, Sweden

Sponsors and Collaborators

Linkoeping University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ly KH, Topooco N, Cederlund H, Wallin A, Bergström 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.

• Responsible Party: Gerhard Andersson, Professor, Linkoeping University
• ClinicalTrials.gov Identifier: NCT01819025
• Other Study ID Numbers: GA-PC-HH-KHL
• First Posted: March 27, 2013
• Last Update Posted: February 7, 2014
• Last Verified: July 2013

Keywords provided by Gerhard Andersson, Linkoeping University:

Depression; Behavioral activation; Smartphone application; Face-to-face; Blended therapy

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders