Online Program to Reduce Depression in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Deprexis, DeprexisPlus

• Registration Number: NCT02740361
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Study Start: 2017-02-15
• Primary Completion: 2021-01-30
• Study Completion: 2021-05-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deprexis	Deprexis, DeprexisPlus	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.
DeprexisPlus	Deprexis, DeprexisPlus	This group will receive the web-based Deprexis program (see above) plus scheduled e-mail contact (1x/week)

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II	Month 0 to Month 3

Secondary Outcome Measures

Name	Time	Method
WHO Quality of Life scale (WHO-QOL BREF)	Month 0 to Month 3	4 subscales (Physical, Psychological, Social Relationships, Environmental)
Multiple Sclerosis Impact Scale (MSIS)	Month 0 to Month 3	2 subscales (Physical and Psychological)
Fatigue Scale for Motor and Cognitive Functions (FSMC)	Month 0 to Month 3	Total score and 2 subscales (Motor and Cognitive)
Chalder Fatigue Scale	Month 0 to Month 3

Trial Locations

Locations (5)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Missouri, Kansas City; 🇺🇸 Kansas City, Kansas, United States

Penn State University; 🇺🇸 State College, Pennsylvania, United States

Charité University; 🇩🇪 Berlin, Germany