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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Epilepsy Centre Alsterdorf
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01663649
First received: August 8, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Depression
 Behavioral: Deprexis
Behavioral: Wait-list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Severity of depressive symptoms [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)


Secondary Outcome Measures:
  • quality of life [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)


Other Outcome Measures:
  • depressive symptoms [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)

  • core self-evaluations [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)

  • suicidal behaviors and tendencies [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)

  • quality of life [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)
Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: web-based treatment program for depression
Active Comparator: Wait-list
Wait-list group (Subjects receive access to deprexis after six months)
 Behavioral: Deprexis
Other Name: web-based treatment program for depression
Behavioral: Wait-list
the wait-list group receives Deprexis after 6 month
Other Name: web-based treatment for depression after 6 month

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663649

Contacts
Contact: Steffen Moritz, Prof. 0049 40 7410 56565 moritz@uke.de

Locations
Germany
Epilepsy Centre Alsterdorf Recruiting
Hamburg, Germany, 22337
Sub-Investigator: Katja Brückner, Ph.D.         
University Medical Center Hamburg-Eppendorf - Neurology Recruiting
Hamburg, Germany, 20246
Contact: Steffen Moritz, Prof.    0049 40 7410 56565    moritz@uke.de   
Sub-Investigator: Christoph Heesen, M.D.         
Sub-Investigator: Stefan Gold, M.D.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Epilepsy Centre Alsterdorf
Investigators
Principal Investigator: Steffen Moritz, Prof. Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01663649     History of Changes
Other Study ID Numbers: Deprexis_2
Study First Received: August 8, 2012
Last Updated: August 8, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Depression
Online-Therapy
Deprexis
Self-help

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on February 27, 2015