Effectiveness of Web-based Treatment for Depression in Patients With Neurologic Disorders

March 24, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

Evaluation of the Effectiveness of a Web-based Treatment Program for Depression (Deprexis) for the Reduction of Depressive Symptoms in Patients With Multiple Sclerosis and Epilepsy. A Randomized Controlled Trial

200 persons (100 with multiple sclerosis and 100 with epilepsy) with depressive symptoms are recruited via the multiple sclerosis clinics of the University Medical Center Hamburg-Eppendorf and the epilepsy centre Alsterdorf and randomly assigned either to the online program deprexis or to a wait-list control condition. All participants receive free-of-charge online access to deprexis either immediately or with a six month delay.

At three time points (1. prior to intervention, 2. after completion of the intervention nine weeks later and 3. at follow-up six month later), both groups are assessed via an anonymous online survey, which was implemented using the software package OPST®.

The survey consists of different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome (IIT analysis for pre versus post). It is assumed that the severity of depressive symptoms will improve to a significantly greater extent in the deprexis than in the wait-list control condition in the course of nine weeks and will be maintained in a six month follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented) or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and emotion-focus interventions. The ten modules are framed by one introductory and one summary module. Communication is carried out online via simulated dialogues. Patients have to respond to narrative text messages from the virtual therapists in multiple-choice response fashion, enabling them to express doubt, to affirm a particular message or to request more information. Text messages are aided with drawings, photographs and animations. The program is adaptive and selects exercises and contents on the basis of the subject's response. The modules are sequential and each module refers and builds upon previous one. Modules can (and should be) repeated within the intervention period.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf - Neurology
      • Hamburg, Germany, 22337
        • Epilepsy Centre Alsterdorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of a confirmed diagnosis of multiple sclerosis or epilepsy
  • self-reported urge to be treated for depressive symptoms (no externally confirmed diagnosis necessary)
  • informed consent (provided online in line with regulations by the Hamburg Department of Data Security)

Exclusion Criteria:

  • unable to provide informed consent
  • diagnosis of bipolar or schizophrenia spectrum disorders
  • substantial neurocognitive impairment (e.g. dementia)
  • acute suicidal tendencies as assessed with the Suicide Behaviors Questionnaire-Revised (SBQ-R). Subjects excluded for this reason are provided various emergency contacts and phone numbers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deprexis
Deprexis (Web-based intervention deprexis consists of ten online modules (plus one introductory and one summary module) representing different psychotherapeutic strategies with a strong focus on evidence-based cognitive-behavioral techniques (e.g. interpersonal skills). Each module lasts approximately 10-60 minutes (e.g. depending on the user´s reading speed). Modules are sequential and organized as simulated dialogues. Each module refers and builds upon previous one. The program is delivered at no cost to participants.)
Behavioral: Deprexis
web-based treatment program for depression
Other Names:
  • web-based treatment program for depression
Active Comparator: Wait-list
Wait-list group (Subjects receive access to deprexis after six months)
Behavioral: Deprexis
web-based treatment program for depression
Other Names:
  • web-based treatment program for depression
Behavioral: Wait-list
the wait-list group receives Deprexis after 6 month
Other Names:
  • web-based treatment for depression after 6 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of depressive symptoms
Time Frame: 7 Days
Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)
7 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 14 days
quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptoms
Time Frame: 7 days
depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)
7 days
core self-evaluations
Time Frame: 7 days
core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)
7 days
suicidal behaviors and tendencies
Time Frame: 7 days
suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)
7 days
quality of life
Time Frame: 7 days
quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Epilepsy Centre Alsterdorf

Investigators

  • Principal Investigator: Steffen Moritz, Prof., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Deprexis_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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