Clinical trial NCT01181583: Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems
Official title: Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorders
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2010-08-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: One week before the treatment starts
measure: Beck Depression Inventory (BDI)
timeFrame: Five weeks after treatment started
measure: Beck Depression Inventory (BDI)
timeFrame: At treatment termination (10 weeks)
measure: Beck Depression Inventory (BDI)
timeFrame: 6 month after treatment ended
measure: Beck Depression Inventory (BDI)
timeFrame: 2 years after treatment ended
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: One week before the treatment starts
measure: Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: One week before the treatment starts
measure: Quality of Life Inventory (QOLI)
timeFrame: One week before the treatment starts
measure: Beck Anxiety Inventory (BAI)
timeFrame: Five weeks after treatment started
measure: Beck Anxiety Inventory (BAI)
timeFrame: At treatment termination (10 weeks)
measure: Beck Anxiety Inventory (BAI)
timeFrame: 6 month after treatment ended
measure: Beck Anxiety Inventory (BAI)
timeFrame: 2 years after treatment ended
measure: Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: Five weeks after treatment started
measure: Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: At treatment termination (10 weeks)
measure: Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: 6 month after treatment ended
measure: Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: 2 years after treatment ended
measure: Quality of Life Inventory (QOLI)
timeFrame: Five weeks after treatment started
measure: Quality of Life Inventory (QOLI)
timeFrame: At treatment termination (10 weeks)
measure: Quality of Life Inventory (QOLI)
timeFrame: 6 month after treatment ended
measure: Quality of Life Inventory (QOLI)
timeFrame: 2 years after treatment ended
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University, Department of Behavioral Sciences and Learning
Study officials:
affiliation: Department of Behavioral Sciences and Learning, Linköping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.