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Online Program to Reduce Depression in MS

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ClinicalTrials.gov Identifier: NCT02740361
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Universitätsklinikum Hamburg-Eppendorf
Cedars-Sinai Medical Center
University of Missouri, Kansas City
Penn State University
King's College London
University Medical Center Goettingen
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Brief Summary:
This is an international, multicenter, randomized controlled trial of an internet-based CBT intervention for depression (Deprexis) conducted in five MS centers in the US and Germany. The trial consists of a three-arm primary trial phase and an extension phase targeted at maintenance.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Deprexis, DeprexisPlus Not Applicable

Detailed Description:

Depression is highly common in MS with a lifetime risk for major depressive disorder (MDD) as high as 25-50% and a 12-month prevalence of up to 25%, particularly in younger patients. Depression in MS has been linked to biological as well as psychological factors and substantially impacts psychosocial function. Importantly, depressive symptoms correlate with decreased quality of life, absence from work, and lower social support and are among the strongest predictors for suicidal ideation in MS patients.

Despite its immediate clinical relevance, depression in MS remains underdiagnosed and often untreated and evidence for the efficacy of pharmacological or non-pharmacological interventions for MS-associated depression is scarce. For example, guidelines recently published by the AAN concluded that evidence for pharmacotherapy and individual or group therapies for MS-depression was insufficient but recommended cognitive behavioral therapy (CBT) delivered by phone with weak level of evidence. Such approaches, however, still require availability of a trained psychotherapist.

Given the mobility problems, cognitive impairment, and fatigue typically associated with MS as well as the limited availability of psychotherapists, self-guided, automated, internet-based interventions may help to overcome treatment barriers often encountered by patients with MS. In a recent phase II randomized controlled trial (RCT) in Germany, the investigators found one such internet-based CBT program, Deprexis, to significantly reduce depressive symptoms in MS (Fischer et al., Lancet Psychiatry 2015). Despite these encouraging results, large, definitive trials of the most promising therapeutic approaches for MS-associated depression that could inform clinical practice are completely lacking.

Here, the investigators conduct a large, international, multicenter RCT of the Deprexis program to treat depression in MS patients. Patients will be recruited in five specialized MS centers in Germany (Charité Berlin and University Medical Center Hamburg) and the US (Cedars Sinai Los Angeles, University of Missouri - Kansas City, and Penn State University). The investigators plan to enroll n=400 patients who will be randomly assigned to two different versions of Deprexis (either Deprexis alone or Deprexis plus regular Email support, DeprexisPlus) for 3 months or a waitlist control group and undergo clinical assessments at baseline and month 3. In addition, the investigators will conduct long-term online follow up at month 6 and month 12.

The trial will address the following three main aims:

Aim 1: To definitively test the effectiveness of Deprexis for reducing depressive symptoms in MS at the end of treatment.

Aim 2: To determine the added value of email support for Deprexis (DeprexisPlus) in MS.

Aim 3: To explore the long-term stability of therapeutic effects (12 months) and the potential of a booster session to enhance maintenance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: International Deprexis Trial in Multiple Sclerosis (IDEMS) - a Multicenter Randomized Controlled Trial
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deprexis
This group will receive access to the web-based Deprexis program, an online tool based on principles of cognitive behavioral therapy. Contents include (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, (8) expressive writing and forgiveness, (9) positive psychology, and (10) emotion-focused interventions.
Behavioral: Deprexis, DeprexisPlus
Online program Deprexis, either as a stand-alone internet-based intervention (Deprexis) or with added standardized email support by a clinical psychologist (DeprexisPlus). In this trial, we will use a Version of Deprexis that has been adapted to MS-specific needs.

Experimental: DeprexisPlus
This group will receive the web-based Deprexis program (see above) plus scheduled e-mail contact (1x/week)
Behavioral: Deprexis, DeprexisPlus
Online program Deprexis, either as a stand-alone internet-based intervention (Deprexis) or with added standardized email support by a clinical psychologist (DeprexisPlus). In this trial, we will use a Version of Deprexis that has been adapted to MS-specific needs.

No Intervention: Waitlist Control
Participants randomized to the control group will wait for access to the Deprexis program (waitlist control) for 6 months. After the 6-month waiting period, participants in this group will have full access to Deprexis.



Primary Outcome Measures :
  1. Beck Depression Inventory-II [ Time Frame: Month 0 to Month 3 ]

Secondary Outcome Measures :
  1. WHO Quality of Life scale (WHO-QOL BREF) [ Time Frame: Month 0 to Month 3 ]
    4 subscales (Physical, Psychological, Social Relationships, Environmental)

  2. Multiple Sclerosis Impact Scale (MSIS) [ Time Frame: Month 0 to Month 3 ]
    2 subscales (Physical and Psychological)

  3. Fatigue Scale for Motor and Cognitive Functions (FSMC) [ Time Frame: Month 0 to Month 3 ]
    Total score and 2 subscales (Motor and Cognitive)

  4. Chalder Fatigue Scale [ Time Frame: Month 0 to Month 3 ]

Other Outcome Measures:
  1. Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) [ Time Frame: Month 0 to Month 3 ]
    Consists of 3 subtests. 1. SMDT (total score), CVLT-II (2 scores: learning score and delayed recall), and BVMT-R (2 scores: learning score and delayed recall)

  2. Suicide Behaviors Questionnaire-Revised (SBQ-R) [ Time Frame: Month 3 ]
  3. Mini International Neuropsychiatric Interview, clinician rating, Version 5.0.0 [ Time Frame: Month 0 to Month 3 ]
    Dichotomous variable "Major Depressive Episode, Current (yes/no)" according to module A of the MINI.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • age > 18
  • neurologist-confirmed diagnosis of MS (all forms)
  • self-reported depressive symptoms (BDI-Fastscreen > 4)
  • fluent in German or English (depending on study site),
  • willingness to engage in self-administration of an iCBT intervention for 3 months and complete follow-up
  • ability to travel to the outpatient center for two clinical assessments (baseline and month 3)
  • internet access at home

Exclusion criteria:

  • unwilling or unable to consent,
  • diagnosis of bipolar or psychosis (as determined by M.I.N.I structured interview),
  • substantial neurocognitive impairments such as dementia or autism
  • moderate or high risk of suicide (according to MINI module C) or by clinical impression
  • very severe depression that would interfere with the ability to participate in the study (based on clinical judgment by the physician at the recruitment site).
  • current psychotherapy/behavioral treatments for depression
  • started pharmacotherapy for depression within the last 2 months
  • MS relapse or steroid treatment in the last 4 weeks
  • concurrent participation in another clinical trial that includes an intervention
  • refusal to saving, processing and forwarding of pseudonymized data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740361


Contacts
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Contact: Stefan M Gold, PhD +49 450 517 594 stefan.gold@charite.de
Contact: Christoph Heesen, MD heesen@uke.de

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Nancy Sicotte, MD         
Principal Investigator: Nancy L Sicotte, MD         
United States, Kansas
University of Missouri, Kansas City Recruiting
Kansas City, Kansas, United States, 66103
Contact: Jared Bruce, PhD         
Principal Investigator: Jared Bruce, PhD         
Sub-Investigator: Sharon Lynch, MD         
United States, Pennsylvania
Penn State University Recruiting
State College, Pennsylvania, United States, 16801
Contact: Peter Arnett, PhD         
Principal Investigator: Peter Arnett, PhD         
Germany
Charité University Recruiting
Berlin, Germany, 10117
Contact: Stefan Gold, PhD       stefan.gold@charite.de   
Contact: Friedemann Paul, MD       friedemann.paul@charite.de   
Principal Investigator: Friedemann Paul, MD         
Universitätsklinikum Hamburg-Eppendorf Active, not recruiting
Hamburg, Germany, 20246
Sponsors and Collaborators
Charite University, Berlin, Germany
National Multiple Sclerosis Society
Universitätsklinikum Hamburg-Eppendorf
Cedars-Sinai Medical Center
University of Missouri, Kansas City
Penn State University
King's College London
University Medical Center Goettingen
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
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Study Director: Stefan M Gold, PhD Charité University, Berlin
Principal Investigator: Friedemann Paul, MD Charité University, Berlin
Principal Investigator: Christoph Heesen, MD Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Nancy Sicotte, MD Cedars-Sinai Medical Center
Principal Investigator: Jared Bruce, PhD University of Missouri, Kansas City
Principal Investigator: Sharon Lynch, MD University of Missouri, Kansas City
Principal Investigator: Peter Arnett, PhD Penn State University
Principal Investigator: Rona Moss-Morris, PhD King's College London
Principal Investigator: Tim Friede, PhD University Medical Center Goettingen
Principal Investigator: Björn Meyer, PhD GAIA Group
Publications:
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Responsible Party: Friedemann Paul, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02740361    
Other Study ID Numbers: IDEMS
RG-1507-05418 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual data on the primary endpoint will be published alongside the trial report in a peer reviewed journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases