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

December 27, 2010 updated by: Linkoeping University

Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden
        • Linköping University, Department of Behavioral Sciences and Learning

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory (BDI)
Time Frame: At treatment termination (10 weeks)
At treatment termination (10 weeks)
Beck Depression Inventory (BDI)
Time Frame: One week before the treatment starts
One week before the treatment starts
Beck Depression Inventory (BDI)
Time Frame: Five weeks after treatment started
Five weeks after treatment started
Beck Depression Inventory (BDI)
Time Frame: 6 month after treatment ended
6 month after treatment ended
Beck Depression Inventory (BDI)
Time Frame: 2 years after treatment ended
2 years after treatment ended

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Inventory (BAI)
Time Frame: At treatment termination (10 weeks)
At treatment termination (10 weeks)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame: At treatment termination (10 weeks)
At treatment termination (10 weeks)
Quality of Life Inventory (QOLI)
Time Frame: At treatment termination (10 weeks)
At treatment termination (10 weeks)
Beck Anxiety Inventory (BAI)
Time Frame: One week before the treatment starts
One week before the treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame: One week before the treatment starts
One week before the treatment starts
Quality of Life Inventory (QOLI)
Time Frame: One week before the treatment starts
One week before the treatment starts
Beck Anxiety Inventory (BAI)
Time Frame: Five weeks after treatment started
Five weeks after treatment started
Beck Anxiety Inventory (BAI)
Time Frame: 6 month after treatment ended
6 month after treatment ended
Beck Anxiety Inventory (BAI)
Time Frame: 2 years after treatment ended
2 years after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame: Five weeks after treatment started
Five weeks after treatment started
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame: 6 month after treatment ended
6 month after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame: 2 years after treatment ended
2 years after treatment ended
Quality of Life Inventory (QOLI)
Time Frame: Five weeks after treatment started
Five weeks after treatment started
Quality of Life Inventory (QOLI)
Time Frame: 6 month after treatment ended
6 month after treatment ended
Quality of Life Inventory (QOLI)
Time Frame: 2 years after treatment ended
2 years after treatment ended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Gerhard Andersson, PhD, Department of Behavioral Sciences and Learning, Linköping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 12, 2010

First Posted (Estimate)

August 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 27, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-VR-DEP2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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