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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Deprexis
Wait-list
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Online-Therapy, Deprexis, Self-help

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Wait-list group

Deprexis

Arm Description

Subjects receive access to deprexis after eight weeks

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.

Outcomes

Primary Outcome Measures

Severity of depressive symptoms
Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)

Secondary Outcome Measures

quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
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.

Full Information

First Posted
July 20, 2011
Last Updated
December 11, 2014
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT01401296
Brief Title
Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms
Official Title
Evaluation of the Effectiveness of a Web-based Treatment Program for Depression (Deprexis) for the Reduction of Depressive Symptoms. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Online-Therapy, Deprexis, Self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list group
Arm Type
Active Comparator
Arm Description
Subjects receive access to deprexis after eight weeks
Arm Title
Deprexis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Deprexis
Other Intervention Name(s)
web-based treatment program for depression
Intervention Description
Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group
Intervention Type
Behavioral
Intervention Name(s)
Wait-list
Other Intervention Name(s)
web-based treatment for depression after 8 weeks
Intervention Description
Behavioral: the wait-list group receives Deprexis after 8 weeks
Primary Outcome Measure Information:
Title
Severity of depressive symptoms
Description
Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Mortz, PhD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.deprexis.com
Description
link to metacognitive training site, where training material can be downloaded cost-free

Learn more about this trial

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

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