Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401296
• Other study ID #: Deprexis
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: December 11, 2014
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2014
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• registration in a moderated online forum exclusively for affective disorders

• (externally) confirmed diagnosis of a unipolar depression

• 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 neurological 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Deprexis
Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group
• Wait-list
Behavioral: the wait-list group receives Deprexis after 8 weeks

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of depressive symptoms	Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)	7 Days	No
Secondary	quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)	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.	7 days	No

External Links

•   link to metacognitive training site, where training material can be downloaded cost-free