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

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:

  • 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.

Sites / Locations

  • University Medical Center Hamburg-Eppendorf - Neurology
  • Epilepsy Centre Alsterdorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deprexis

Wait-list

Arm Description

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.)

Wait-list group (Subjects receive access to deprexis after six months)

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

Full Information

First Posted
August 8, 2012
Last Updated
March 24, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Epilepsy Centre Alsterdorf
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1. Study Identification

Unique Protocol Identification Number
NCT01663649
Brief Title
Effectiveness of Web-based Treatment for Depression in Patients With Neurologic Disorders
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Epilepsy Centre Alsterdorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deprexis
Arm Type
Experimental
Arm Description
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.)
Arm Title
Wait-list
Arm Type
Active Comparator
Arm Description
Wait-list group (Subjects receive access to deprexis after six months)
Intervention Type
Behavioral
Intervention Name(s)
Deprexis
Other Intervention Name(s)
web-based treatment program for depression
Intervention Description
web-based treatment program for depression
Intervention Type
Behavioral
Intervention Name(s)
Wait-list
Other Intervention Name(s)
web-based treatment for depression after 6 month
Intervention Description
the wait-list group receives Deprexis after 6 month
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
Description
quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
depressive symptoms
Description
depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)
Time Frame
7 days
Title
core self-evaluations
Description
core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)
Time Frame
7 days
Title
suicidal behaviors and tendencies
Description
suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)
Time Frame
7 days
Title
quality of life
Description
quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Moritz, Prof.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf - Neurology
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Epilepsy Centre Alsterdorf
City
Hamburg
ZIP/Postal Code
22337
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22677231
Citation
Moritz S, Schilling L, Hauschildt M, Schroder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012 Aug;50(7-8):513-21. doi: 10.1016/j.brat.2012.04.006. Epub 2012 May 3.
Results Reference
background
PubMed Identifier
19632969
Citation
Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151.
Results Reference
background
PubMed Identifier
26359900
Citation
Fischer A, Schroder J, Vettorazzi E, Wolf OT, Pottgen J, Lau S, Heesen C, Moritz S, Gold SM. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015 Mar;2(3):217-23. doi: 10.1016/S2215-0366(14)00049-2. Epub 2015 Feb 25.
Results Reference
result
PubMed Identifier
25410633
Citation
Schroder J, Bruckner K, Fischer A, Lindenau M, Kother U, Vettorazzi E, Moritz S. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014 Dec;55(12):2069-76. doi: 10.1111/epi.12833. Epub 2014 Nov 19.
Results Reference
result

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

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