NCT01181583

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
Last Updated

December 28, 2010

Status Verified

December 1, 2010

First QC Date

August 9, 2010

Last Update Submit

December 27, 2010

Conditions

Outcome Measures

Primary Outcomes (5)

  • Beck Depression Inventory (BDI)

    One week before the treatment starts

  • Beck Depression Inventory (BDI)

    Five weeks after treatment started

  • Beck Depression Inventory (BDI)

    At treatment termination (10 weeks)

  • Beck Depression Inventory (BDI)

    6 month after treatment ended

  • Beck Depression Inventory (BDI)

    2 years after treatment ended

Secondary Outcomes (15)

  • Beck Anxiety Inventory (BAI)

    One week before the treatment starts

  • Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)

    One week before the treatment starts

  • Quality of Life Inventory (QOLI)

    One week before the treatment starts

  • Beck Anxiety Inventory (BAI)

    Five weeks after treatment started

  • Beck Anxiety Inventory (BAI)

    At treatment termination (10 weeks)

  • +10 more secondary outcomes

Study Arms (3)

Tailored Internet-delivered CBT

EXPERIMENTAL
Behavioral: Tailored Internet-delivered CBT

Non-tailored Internet-delivered CBT

EXPERIMENTAL
Behavioral: Non-tailored Internet-delivered CBT

Online discussion group

ACTIVE COMPARATOR
Behavioral: Online discussion group

Interventions

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.

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.

Non-tailored Internet-delivered CBT

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

Online discussion group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Major Depressive Disorder
  • or more on MADRS-S

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University, Department of Behavioral Sciences and Learning

Linköping, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Gerhard Andersson, PhD

    Department of Behavioral Sciences and Learning, Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 13, 2010

Last Updated

December 28, 2010

Record last verified: 2010-12

Locations