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

NCT01663649 | Completed

• 1 other identifier: Deprexis_2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Depression; Online-Therapy; Deprexis; Self-help

Outcome Measures

Primary Outcomes (1)

• Severity of depressive symptoms

  Severity of depressive symptoms as assessed with the Beck Depression Inventory (BDI)

  7 Days

Secondary Outcomes (1)

• quality of life

  14 days

Other Outcomes (4)

• depressive symptoms

  7 days

• core self-evaluations

  7 days

• suicidal behaviors and tendencies

  7 days

Study Arms (2)

Deprexis

EXPERIMENTAL

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.)

Behavioral: Deprexis

Wait-list

ACTIVE COMPARATOR

Wait-list group (Subjects receive access to deprexis after six months)

Behavioral: Deprexis; Behavioral: Wait-list

Interventions

Deprexis BEHAVIORAL

web-based treatment program for depression

Also known as: web-based treatment program for depression

Deprexis; Wait-list

Wait-list BEHAVIORAL

the wait-list group receives Deprexis after 6 month

Also known as: web-based treatment for depression after 6 month

Wait-list

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Epilepsy Centre Alsterdorf: collaborator

Study Sites (2)

Epilepsy Centre Alsterdorf

Hamburg, Hamburg, 22337, Germany

Location

University Medical Center Hamburg-Eppendorf - Neurology

Hamburg, 20246, Germany

Location

Related Publications (4)

• Moritz S, Schilling L, Hauschildt M, Schroder 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.

  PMID: 22677231 BACKGROUND

• 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.

  PMID: 19632969 BACKGROUND

• Fischer A, Schroder J, Vettorazzi E, Wolf OT, Pottgen 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/S2215-0366(14)00049-2. Epub 2015 Feb 25.

  PMID: 26359900 RESULT

• Schroder J, Bruckner K, Fischer A, Lindenau M, Kother 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.12833. Epub 2014 Nov 19.

  PMID: 25410633 RESULT

MeSH Terms

Conditions

Depression

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Steffen Moritz, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 13, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

DE (2)