Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms

December 11, 2014 updated by: Universitätsklinikum Hamburg-Eppendorf

Evaluation of the Effectiveness of a Web-based Treatment Program for Depression (Deprexis) for the Reduction of Depressive Symptoms. A Randomized Controlled Trial

200 persons with depression are recruited via internet depression forums devoted to depression and are 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 an eight week delay.

Prior to intervention and eight weeks 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. 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 eight weeks.

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)

200

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

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:

  • registration in a moderated online forum exclusively for affective disorders
  • (externally) confirmed diagnosis of a unipolar depression
  • 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 neurological 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
Active Comparator: Wait-list group
Subjects receive access to deprexis after eight weeks
Behavioral: Wait-list
Behavioral: the wait-list group receives Deprexis after 8 weeks
Other Names:
  • web-based treatment for depression after 8 weeks
Experimental: 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
Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group
Other Names:
  • web-based treatment program for depression

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 as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
Time Frame: 7 days
The WHO-QOL- Bref is an abbreviated 26-item version of the WHO-QOL-100 which covers four domains of quality of life (QoL): physical. psychological. social. environment.
7 days

Collaborators and Investigators

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Steffen Mortz, PhD, 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.

Helpful Links

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

May 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Deprexis

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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