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

Primary Purpose

Depression, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tailored Internet-delivered CBT
Non-tailored Internet-delivered CBT
Online discussion group
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Linköping University, Department of Behavioral Sciences and Learning

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Tailored Internet-delivered CBT

Non-tailored Internet-delivered CBT

Online discussion group

Arm Description

Outcomes

Primary Outcome Measures

Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI)

Secondary Outcome Measures

Beck Anxiety Inventory (BAI)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Quality of Life Inventory (QOLI)
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Quality of Life Inventory (QOLI)
Quality of Life Inventory (QOLI)
Quality of Life Inventory (QOLI)
Quality of Life Inventory (QOLI)

Full Information

First Posted
August 9, 2010
Last Updated
December 27, 2010
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01181583
Brief Title
Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems
Acronym
TAYLOR1
Official Title
Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Internet-delivered CBT
Arm Type
Experimental
Arm Title
Non-tailored Internet-delivered CBT
Arm Type
Experimental
Arm Title
Online discussion group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet-delivered CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-tailored Internet-delivered CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online discussion group
Intervention Description
Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
One week before the treatment starts
Title
Beck Depression Inventory (BDI)
Time Frame
Five weeks after treatment started
Title
Beck Depression Inventory (BDI)
Time Frame
At treatment termination (10 weeks)
Title
Beck Depression Inventory (BDI)
Time Frame
6 month after treatment ended
Title
Beck Depression Inventory (BDI)
Time Frame
2 years after treatment ended
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Time Frame
One week before the treatment starts
Title
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame
One week before the treatment starts
Title
Quality of Life Inventory (QOLI)
Time Frame
One week before the treatment starts
Title
Beck Anxiety Inventory (BAI)
Time Frame
Five weeks after treatment started
Title
Beck Anxiety Inventory (BAI)
Time Frame
At treatment termination (10 weeks)
Title
Beck Anxiety Inventory (BAI)
Time Frame
6 month after treatment ended
Title
Beck Anxiety Inventory (BAI)
Time Frame
2 years after treatment ended
Title
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame
Five weeks after treatment started
Title
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame
At treatment termination (10 weeks)
Title
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame
6 month after treatment ended
Title
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time Frame
2 years after treatment ended
Title
Quality of Life Inventory (QOLI)
Time Frame
Five weeks after treatment started
Title
Quality of Life Inventory (QOLI)
Time Frame
At treatment termination (10 weeks)
Title
Quality of Life Inventory (QOLI)
Time Frame
6 month after treatment ended
Title
Quality of Life Inventory (QOLI)
Time Frame
2 years after treatment ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Department of Behavioral Sciences and Learning, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University, Department of Behavioral Sciences and Learning
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22615841
Citation
Johansson R, Sjoberg E, Sjogren 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.
Results Reference
derived

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

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