1. To investigate the non-inferiority of blended CBT compared to proven effective face-to-face CBT according to the TREFAMS-CBT treatment protocol in severely fatigued patients with MS, using a non-inferiority margin of 5.3 points on the Checklist…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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).
Background summary
The recent results of the TREFAMS-ACE research programme with 3 randomized
clinical trials showed that severe MS-related fatigue can be significantly
reduced with individual face-to-face CBT. TREFAMS is an acronym for TReating
FAtigue in Multiple Sclerosis, while ACE refers to the rehabilitation treatment
methods under study, i.e. Aerobic training, Cognitive behavioural therapy, and
Energy conservation management. The TREFAMS-CBT treatment protocol consists of
12 face-to-face therapy sessions in 4-5 months. However, there are important
barriers for patients to follow such an intervention, like having to travel to
a treatment centre. Especially for severely fatigued patients this is
burdensome. Blended CBT, i.e. a combination of face-to-face sessions and
web-based CBT, has the potential to address these drawbacks. TREFAMS-CBT was
effective in reducing fatigue directly post-treatment. However, the positive
effects gradually wore off after treatment cessation. Therefore, booster
sessions will be added to the blended and face-to-face treatment protocol to
maintain post-treatment effects over the long-term.
Study objective
1. To investigate the non-inferiority of blended CBT compared to proven
effective face-to-face CBT according to the TREFAMS-CBT treatment protocol in
severely fatigued patients with MS, using a non-inferiority margin of 5.3
points on the Checklist of Individual Strength (CIS20r) fatigue subscale.
2. To study the effectiveness of CBT booster sessions to improve long-term
outcome with respect to fatigue severity at 1-year follow-up.
Study design
A observer-blinded non-inferiority multicentre randomized clinical trial. At
baseline patients will be randomized (R1) to face-to-face CBT or blended CBT.
At the ed of the intitial treatment patients will be randomized again (R2) to
either booster sessions or no additional intervention until follow-up. Total
follow-up is 1 year.
Intervention
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 and 3 video consultations.
The CBT will be applied by trained and supervised psychologists.
Study burden and risks
Patients will be informed about a total study participation time of one year.
Patients in both groups receive a treatment for their fatigue, which are both
expected to be effective. Their benefit will be a decrease in severe fatigue.
There are no risks to their health. The burden of participating in this
scientific study is that participants will have to complete additional
questionnaires and a computer task, before and after treatment and at 9 and 12
months follow-up after randomization. Most of these measurements can be
completed online.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Definitive diagnosis of MS
- Being severely fatigued (CIS20r fatigue >= 35).
- Aged between 18 and 70 years
- Ambulatory patients (EDSS <= 6)
- No evident signs of exacerbation or a corticosteroid treatment in the past 3
months
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62622.029.17 |