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

Depression Clinical Trial

— TAYLOR1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181583
• Other study ID #: GA-VR-DEP2009-1
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: December 27, 2010

Study information

• Verified date: December 2010
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.
• 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.
• Online discussion group
Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.

Locations

Country	Name	City	State
Sweden	Linköping University, Department of Behavioral Sciences and Learning	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI)		One week before the treatment starts
Primary	Beck Depression Inventory (BDI)		Five weeks after treatment started
Primary	Beck Depression Inventory (BDI)		At treatment termination (10 weeks)
Primary	Beck Depression Inventory (BDI)		6 month after treatment ended
Primary	Beck Depression Inventory (BDI)		2 years after treatment ended
Secondary	Beck Anxiety Inventory (BAI)		One week before the treatment starts
Secondary	Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)		One week before the treatment starts
Secondary	Quality of Life Inventory (QOLI)		One week before the treatment starts
Secondary	Beck Anxiety Inventory (BAI)		Five weeks after treatment started
Secondary	Beck Anxiety Inventory (BAI)		At treatment termination (10 weeks)
Secondary	Beck Anxiety Inventory (BAI)		6 month after treatment ended
Secondary	Beck Anxiety Inventory (BAI)		2 years after treatment ended
Secondary	Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)		Five weeks after treatment started
Secondary	Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)		At treatment termination (10 weeks)
Secondary	Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)		6 month after treatment ended
Secondary	Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)		2 years after treatment ended
Secondary	Quality of Life Inventory (QOLI)		Five weeks after treatment started
Secondary	Quality of Life Inventory (QOLI)		At treatment termination (10 weeks)
Secondary	Quality of Life Inventory (QOLI)		6 month after treatment ended
Secondary	Quality of Life Inventory (QOLI)		2 years after treatment ended