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Completed

NCT Number: NCT01181583

Tailored Internet-delivered Cognitive Behaviour Therapy 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.

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Key information

Conditions

Depression Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University, Department of Behavioral Sciences and Learning

Linköping, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored Internet-delivered CBT

Behavioral

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

Behavioral

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

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: TAYLOR1

Important dates

First posted
Aug 13, 2010
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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