Depression Clinical Trial
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
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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