e-TREFAMS-CBT: Blended CBT for MS-related fatigue

Recruiting

• Conditions: Multiple Sclerosis related fatigueMS-gerelateerde vermoeidheidCognitive Behavioural TherapyBlended cognitive Behavioural Therapy

• Registration Number: NL-OMON23922
• Lead Sponsor: Prof. dr. Vincent de GrootVU University Medical CenterDepartment of Rehabilitation Medicine PO BOX 7057, 1007 MB Amsterdam v.degroot@vumc.nl020-44 40763

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 166

Inclusion Criteria

a) definitive diagnosis of MS; b) severely fatigued (CIS20r fatigue ¡Ý 35); c) ambulatory patients (EDSS ¡Ü 6); d) no evident signs of an exacerbation, or a corticosteroid treatment in the past 3 months; e) no current infections; f:) no anaemia; g) a normal thyroid function.

Exclusion Criteria

a) depression (assessed with BDI-II-PC ≥ 4 and M.I.N.I) ; b) primary sleep disorders; c) severe comorbidity (CIRS item scores ¡Ý 3); d) current pregnancy or having given birth in the past 3 months; e) pharmacological treatment for fatigue that was started in the past 3 months (e.g. Amantadine, Modafinil, Ritalin, Pemoline); f) non-pharmacological therapies for fatigue that took place in the past 3 months. Patients who already received CBT in the TREFAMS study will be excluded as well.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In both subsequent trials, fatigue as measured by the CIS20r fatigue severity subscale will be the primary outcome. A cut-off score of 35 or higher is an indication for severe fatigue.

Secondary Outcome Measures

Name	Time	Method
- PROMIS fatigue - Short Form 8a <br /><br>- FSS (Fatigue Severity Scale) <br /><br>- CIS20r subscales reduction in motivation due to fatigue, reduction in physical activity due to fatigue, and concentration problems <br /><br>- The Sickness Impact Profile (SIP) <br /><br>- Work and Social Adjustment Scale (WSAS) - Health-related quality of life will be assessed by the SF36 <br>