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

Tracking Information

• First Submitted Date: March 22, 2013
• First Posted Date: March 27, 2013
• Last Update Posted Date: February 7, 2014
• Study Start Date: March 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 26, 2013)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 26, 2013)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
• Official Title: Face-to-face CBT Treatment of Depression With Smartphone Support
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Depression

Intervention

• 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.
• Behavioral: CBT, treatment as usual
  10 sessions of face-to-face therapy, full behavioral activation

Study Arms

• 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.
  Intervention: Behavioral: 4 face-to-face therapy session and a smartphone-app
• Active Comparator: TAU
  10 sessions of face-to-face therapy, full behavioral activation
  Intervention: Behavioral: CBT, treatment as usual

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2014): 88
• Original Estimated Enrollment (submitted: March 26, 2013): 100
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT01819025
• Other Study ID Numbers: GA-PC-HH-KHL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gerhard Andersson, Linkoeping University
• Original Responsible Party: Same as current
• Current Study Sponsor: Linkoeping University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Linkoeping University
• Verification Date: July 2013