Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms
200 persons with depression are recruited via internet depression forums devoted to depression and are 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 an eight week delay.
Prior to intervention and eight weeks 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. 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 eight weeks.
|Study Design:||Allocation: Randomized
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. A Randomized Controlled Trial|
- 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)
- quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF) [ Time Frame: 7 days ] [ Designated as safety issue: No ]The WHO-QOL- Bref is an abbreviated 26-item version of the WHO-QOL-100 which covers four domains of quality of life (QoL): physical. psychological. social. environment.
|Study Start Date:||May 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Wait-list group
Subjects receive access to deprexis after eight weeks
Behavioral: the wait-list group receives Deprexis after 8 weeks
Other Name: web-based treatment for depression after 8 weeks
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 (10 sessions) delivered online versus wait-list control group
Other Name: web-based treatment program for depression
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401296
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Steffen Mortz, PhD||Universitätsklinikum Hamburg-Eppendorf|