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Completed

NCT Number: NCT01663649

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Epilepsy Centre Alsterdorf, Hamburg, Free and Hanseatic City of Hamburg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deprexis

Behavioral

web-based treatment program for depression

Other names: web-based treatment program for depression

Wait-list

Behavioral

the wait-list group receives Deprexis after 6 month

Other names: web-based treatment for depression after 6 month

Primary outcomes

  1. Severity of depressive symptoms

    Time frame: 7 Days

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

Secondary outcomes

  1. quality of life

    Time frame: 14 days

    quality of life as assessed by the WHO Quality of Life scale (WHO-QOL BREF)

Other outcomes

  1. depressive symptoms

    Time frame: 7 days

    depressive symptoms as assessed by the Quick Inventory of Depressive Symptomatology (QIDS)

  2. core self-evaluations

    Time frame: 7 days

    core self-evaluations as assessed by the Core Self-Evaluations Scale (CSES)

  3. suicidal behaviors and tendencies

    Time frame: 7 days

    suicidal behaviors and tendencies as assessed by the Suicidal Behaviors Questionnaire-Revised (SBQ-R)

  4. quality of life

    Time frame: 7 days

    quality of life as assessed by the Hamburg MS Quality of Life Questionnaire (HALEMS)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Epilepsy Centre Alsterdorf

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 13, 2012
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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