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

August 8, 2012
August 8, 2012
June 2012
December 2013   (final data collection date for primary outcome measure)
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)
Same as current
No Changes Posted
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)
Same as current
  • 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)
Same as current
 
Effectiveness of Web-based Treatment for Depression in Patients With Neurologic Disorders
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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
  • 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.)
    Intervention: Behavioral: Deprexis
  • Active Comparator: Wait-list
    Wait-list group (Subjects receive access to deprexis after six months)
    Interventions:
    • Behavioral: Deprexis
    • Behavioral: Wait-list

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Steffen Moritz, Prof. 0049 40 7410 56565 moritz@uke.de
Germany
 
NCT01663649
Deprexis_2
No
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
Epilepsy Centre Alsterdorf
Principal Investigator: Steffen Moritz, Prof. Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP