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Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems (TAYLOR1)

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ClinicalTrials.gov Identifier: NCT01181583
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Linkoeping University

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE August 13, 2010
Last Update Posted Date December 28, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Beck Depression Inventory (BDI) [ Time Frame: One week before the treatment starts ]
  • Beck Depression Inventory (BDI) [ Time Frame: Five weeks after treatment started ]
  • Beck Depression Inventory (BDI) [ Time Frame: At treatment termination (10 weeks) ]
  • Beck Depression Inventory (BDI) [ Time Frame: 6 month after treatment ended ]
  • Beck Depression Inventory (BDI) [ Time Frame: 2 years after treatment ended ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
  • Beck Anxiety Inventory (BAI) [ Time Frame: One week before the treatment starts ]
  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: One week before the treatment starts ]
  • Quality of Life Inventory (QOLI) [ Time Frame: One week before the treatment starts ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Five weeks after treatment started ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: At treatment termination (10 weeks) ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: 6 month after treatment ended ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: 2 years after treatment ended ]
  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: Five weeks after treatment started ]
  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: At treatment termination (10 weeks) ]
  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: 6 month after treatment ended ]
  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: 2 years after treatment ended ]
  • Quality of Life Inventory (QOLI) [ Time Frame: Five weeks after treatment started ]
  • Quality of Life Inventory (QOLI) [ Time Frame: At treatment termination (10 weeks) ]
  • Quality of Life Inventory (QOLI) [ Time Frame: 6 month after treatment ended ]
  • Quality of Life Inventory (QOLI) [ Time Frame: 2 years after treatment ended ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems
Official Title  ICMJE Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
Brief Summary The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.
Detailed Description Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Anxiety Disorders
Intervention  ICMJE
  • Behavioral: Tailored Internet-delivered CBT
    This intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
  • Behavioral: Non-tailored Internet-delivered CBT
    Specific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.
  • Behavioral: Online discussion group
    Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.
Study Arms  ICMJE
  • Experimental: Tailored Internet-delivered CBT
    Intervention: Behavioral: Tailored Internet-delivered CBT
  • Experimental: Non-tailored Internet-delivered CBT
    Intervention: Behavioral: Non-tailored Internet-delivered CBT
  • Active Comparator: Online discussion group
    Intervention: Behavioral: Online discussion group
Publications * Johansson R, Sjöberg E, Sjögren M, Johnsson E, Carlbring P, Andersson T, Rousseau A, Andersson G. Tailored vs. standardized internet-based cognitive behavior therapy for depression and comorbid symptoms: a randomized controlled trial. PLoS One. 2012;7(5):e36905. doi: 10.1371/journal.pone.0036905. Epub 2012 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2010)
121
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Major Depressive Disorder
  • 15 or more on MADRS-S

Exclusion Criteria:

  • Severe depression (more than 35 on MADRS-S or based on interview)
  • Severe psychiatric condition (e.g. psychosis or bipolar disorder)
  • Changed medication during the last three months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01181583
Other Study ID Numbers  ICMJE GA-VR-DEP2009-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Andersson/Professor, Linkoeping University
Study Sponsor  ICMJE Linkoeping University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Andersson, PhD Department of Behavioral Sciences and Learning, Linköping University
PRS Account Linkoeping University
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP