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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Deprexis; Behavioral: Wait-list

• Registration Number: NCT01663649
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait-list	Wait-list	Wait-list group (Subjects receive access to deprexis after six months)
Deprexis	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.)
Wait-list	Deprexis	Wait-list group (Subjects receive access to deprexis after six months)

Primary Outcome Measures

Name	Time	Method
Severity of depressive symptoms	7 Days	Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)

Secondary Outcome Measures

Name	Time	Method
quality of life	14 days	quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)

Trial Locations

Locations (2)

University Medical Center Hamburg-Eppendorf - Neurology; 🇩🇪 Hamburg, Germany

Epilepsy Centre Alsterdorf; 🇩🇪 Hamburg, Germany