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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663649
• Other study ID #: Deprexis_2
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: March 24, 2015
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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: 180
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Deprexis
web-based treatment program for depression
• Wait-list
the wait-list group receives Deprexis after 6 month

Locations

Country	Name	City	State
Germany	Epilepsy Centre Alsterdorf	Hamburg
Germany	University Medical Center Hamburg-Eppendorf - Neurology	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Epilepsy Centre Alsterdorf

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Fischer A, Schröder J, Vettorazzi E, Wolf OT, Pöttgen J, Lau S, Heesen C, Moritz S, Gold SM. An online programme to reduce depression in patients with multiple sclerosis: a randomised controlled trial. Lancet Psychiatry. 2015 Mar;2(3):217-23. doi: 10.1016 — View Citation

Meyer B, Berger T, Caspar F, Beevers CG, Andersson G, Weiss M. Effectiveness of a novel integrative online treatment for depression (Deprexis): randomized controlled trial. J Med Internet Res. 2009 May 11;11(2):e15. doi: 10.2196/jmir.1151. — View Citation

Moritz S, Schilling L, Hauschildt M, Schröder J, Treszl A. A randomized controlled trial of internet-based therapy in depression. Behav Res Ther. 2012 Aug;50(7-8):513-21. doi: 10.1016/j.brat.2012.04.006. Epub 2012 May 3. — View Citation

Schröder J, Brückner K, Fischer A, Lindenau M, Köther U, Vettorazzi E, Moritz S. Efficacy of a psychological online intervention for depression in people with epilepsy: a randomized controlled trial. Epilepsia. 2014 Dec;55(12):2069-76. doi: 10.1111/epi.12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	depressive symptoms	depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)	7 days	No
Other	core self-evaluations	core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)	7 days	No
Other	suicidal behaviors and tendencies	suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)	7 days	Yes
Other	quality of life	quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)	7 days	No
Primary	Severity of depressive symptoms	Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)	7 Days	No
Secondary	quality of life	quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)	14 days	No