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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

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Disorders Behavioral: Tailored Internet-delivered CBT Behavioral: Non-tailored Internet-delivered CBT Behavioral: Online discussion group Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tailored Internet-delivered CBT 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.
Experimental: Non-tailored Internet-delivered CBT 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.
Active Comparator: Online discussion group 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.



Primary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: One week before the treatment starts ]
  2. Beck Depression Inventory (BDI) [ Time Frame: Five weeks after treatment started ]
  3. Beck Depression Inventory (BDI) [ Time Frame: At treatment termination (10 weeks) ]
  4. Beck Depression Inventory (BDI) [ Time Frame: 6 month after treatment ended ]
  5. Beck Depression Inventory (BDI) [ Time Frame: 2 years after treatment ended ]

Secondary Outcome Measures :
  1. Beck Anxiety Inventory (BAI) [ Time Frame: One week before the treatment starts ]
  2. Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: One week before the treatment starts ]
  3. Quality of Life Inventory (QOLI) [ Time Frame: One week before the treatment starts ]
  4. Beck Anxiety Inventory (BAI) [ Time Frame: Five weeks after treatment started ]
  5. Beck Anxiety Inventory (BAI) [ Time Frame: At treatment termination (10 weeks) ]
  6. Beck Anxiety Inventory (BAI) [ Time Frame: 6 month after treatment ended ]
  7. Beck Anxiety Inventory (BAI) [ Time Frame: 2 years after treatment ended ]
  8. Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: Five weeks after treatment started ]
  9. Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: At treatment termination (10 weeks) ]
  10. Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: 6 month after treatment ended ]
  11. Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S) [ Time Frame: 2 years after treatment ended ]
  12. Quality of Life Inventory (QOLI) [ Time Frame: Five weeks after treatment started ]
  13. Quality of Life Inventory (QOLI) [ Time Frame: At treatment termination (10 weeks) ]
  14. Quality of Life Inventory (QOLI) [ Time Frame: 6 month after treatment ended ]
  15. Quality of Life Inventory (QOLI) [ Time Frame: 2 years after treatment ended ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181583


Locations
Sweden
Linköping University, Department of Behavioral Sciences and Learning
Linköping, Sweden
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Gerhard Andersson, PhD Department of Behavioral Sciences and Learning, Linköping University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Andersson/Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01181583     History of Changes
Other Study ID Numbers: GA-VR-DEP2009-1
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders