Blended versus face-to-face Cognitive Behavioural Therapy in treating severe fatigue in patients with MS - an observer-blinded randomized clinical trial testing non-inferiority at post-treatment and long-term effectiveness.

Blended versus face-to-face Cognitive Behavioural Therapy in treating severe fatigue in patients with MS - an observer-blinded randomized clinical trial testing non-inferiority at post-treatment and long-term effectiveness. - e-Trefams CBT: blended CBT for MS-related fatigue

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55707

Enrollment

150

Registered

2017-12-21

Start date

2018-04-05

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatigue in patients with Multipele Sclerosis MS-related fatigue

Interventions

Patients will receive 12 face-to-face CBT sessions, according to the TREFAMS-CBT protocol or blended CBT, based on the same protocol, but supported with web-based assignments and only 2 face-to-face

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Definitive diagnosis of MS - Being severely fatigued (CIS20r fatigue >= 35). - Aged between 18 and 70 years - Ambulatory patients (EDSS

Exclusion criteria

Exclusion criteria: - Depression (BDI-II-PC >= 4 + depression assessed by M.I.N.I.) - primary sleep disorder - severe co-morbidity (CIRS item scores >= 3) - current pregnancy or having given birth in the past three months - Started with pharmacological treatment for fatigue in the past three months (other pharmacological treatment, p.e. for MS, is allowed) - Started with non-pharmacological therapies for fatigue in the past three months - previous treatment with Trefams-CBT

Design outcomes

Primary

Measure	Time frame
Fatigue severity measured by the CIS20r subscale fatigue severity will be the primary outcome in the non-inferiority trial (at week 20) and in the additional booster trial (at 12 months).	—

Secondary

Measure	Time frame
- Fatigue as measured with the PROMIS fatigue-short form 8a, and the FSS. - CIS20r subscales reduction in motivation due to fatigue, reduction in physical activity due to fatigue, and concentration problems - limitations in daily functioning as measured with the SIP, WSAS and SF-36. other determinants: - Socio-demographic and disease-related characteristics - Symptom Checklist (SCL-90) - Epworth Sleepiness Scale (ESS) - Pittburg Sleep Quality Index (PSQI) - The Multiple Sclerosis Self-Management Scale - Visual Probe Task (VPT) - Interpretative bias task - Sleeplog Patient-therapist variabels: - Treatment preference at baseline (online vs f2f) - Treatment Outcome Expectations Questionnaire (TOEQ) - Working Alliance Inventory (WAI-SR) - Satisfaction with treatment - System Usability Scale (SUS) - Patient therapy adherence Patient-tailoring (blended ) CBT modules - Impact of Event Scale (IES) - Illness Cognition Questionnaire (ICQ) - Cognitive-Behavioural Responses on Symptoms (CBRSQ) - Beck Depression Inventory (BDI-II-PC) - Fear of Disease Progression-SF (FoPQ-SF) - Self-Efficacy Scale (SES-28) - Jacobsen Fatigue Catastrophizing Scale - Illness Management Questionnaire (IMQ) - Social Support List (SSl & SSL D) - Pain Catastrophizing Scale (PCS).	—

Measure

Time frame

- Fatigue as measured with the PROMIS fatigue-short form 8a, and the FSS. - CIS20r subscales reduction in motivation due to fatigue, reduction in physical activity due to fatigue, and concentration problems - limitations in daily functioning as measured with the SIP, WSAS and SF-36. other determinants: - Socio-demographic and disease-related characteristics - Symptom Checklist (SCL-90) - Epworth Sleepiness Scale (ESS) - Pittburg Sleep Quality Index (PSQI) - The Multiple Sclerosis Self-Management Scale - Visual Probe Task (VPT) - Interpretative bias task - Sleeplog Patient-therapist variabels: - Treatment preference at baseline (online vs f2f) - Treatment Outcome Expectations Questionnaire (TOEQ) - Working Alliance Inventory (WAI-SR) - Satisfaction with treatment - System Usability Scale (SUS) - Patient therapy adherence Patient-tailoring (blended ) CBT modules - Impact of Event Scale (IES) - Illness Cognition Questionnaire (ICQ) - Cognitive-Behavioural Responses on Symptoms (CBRSQ) - Beck Depression Inventory (BDI-II-PC) - Fear of Disease Progression-SF (FoPQ-SF) - Self-Efficacy Scale (SES-28) - Jacobsen Fatigue Catastrophizing Scale - Illness Management Questionnaire (IMQ) - Social Support List (SSl & SSL D) - Pain Catastrophizing Scale (PCS).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)