Multiple Sclerosis Journal - October 2017 - 1544

Multiple Sclerosis Journal 23(11)
handling pain (more information about the modules is
available in Supplementary Appendix 2). The intervention was patient-tailored: questionnaires with predefined cut-off scores and information from the intake
session with the psychologist were used to determine
which modules were indicated for the patient. After
an intake session in which information was provided
on the cognitive behavioral model of MS-related
fatigue and CBT, patients started by formulating their
treatment goals. The following sessions addressed the
fatigue-maintaining cognitions and behaviors and
were aimed at realizing the set treatment goals.
The final therapy sessions focused on integrating
the obtained skills into daily life and on how
patients should handle relapses of fatigue. All CBT
therapists were state-certified healthcare psychologists who received a 3-day course on how to deliver
CBT according to the TREFAMS-CBT protocol.
Furthermore, the CBT therapists received supervision every other week from an experienced CBT
psychologist.
The control intervention consisted of a protocolled
treatment by an experienced MS nurse that included
three consultations of 45 minutes over a 4-month
period, and intended. It was developed to control for
attention from a MS-professional and information
about fatigue, that is, to control for non-specific treatment effects, this should thus not be considered as an
active or lower dose treatment. The study protocol did
not allow the MS nurses to provide active advices or
refer patients to a psychologist or other healthcare
professionals for the treatment of fatigue. During the
consultations, the patient received written and oral
information about MS-related fatigue, and patients
discussed their personal experiences in coping with
fatigue and other fatigue-related issues. The consultations were guided by the questions that patients had
about their fatigue and the provided booklet. A more
detailed description of the CBT intervention and
the MS nurse consultations is available elsewhere
(Supplementary Appendix 1 and Supplementary
Appendix 2).12
Outcomes
Outcome measures were completed at baseline,
8 weeks (T8), 16 weeks (T16; i.e. post-intervention),
26 weeks (T26), and 52 weeks (T52) of follow-up. All
time-points were used in the longitudinal analyses of
the primary and secondary outcomes. Baseline and
T52 measurements included socio-demographic and
disease characteristics. The primary outcome measures were the CIS20r fatigue and the IPA.14,15
Secondary outcomes for fatigue were Fatigue Severity
1544

Scale (FSS),16 Modified Fatigue Impact Scale
(MFIS),17 and the CIS20r subscales physical activity,
concentration, and motivation.14 Secondary outcomes
for participation were the Medical Outcome Study
Short Form 3618 (SF36) and the Rehabilitation
Activities Profile (RAP).19
The CIS20r subscale fatigue14 was used to measure
MS-related fatigue. It consists of eight statements that
are rated on a 7-point scale; the score ranges from 8 to
56 points. All participants needed a score of 35 or
higher on the CIS20r fatigue before enrollment in the
TREFAMS study. A higher score means more severe
fatigue. The CIS20r focuses on the previous 2 weeks
and is considered reliable and valid for measuring
fatigue in patients with MS.20 The CIS20r is widely
used in Dutch research studies, and it has been shown
to be sensitive to the effects of fatigue interventions in
Chronic Fatigue Syndrome, cancer survivors, patient
during cancer treatment, patients with neuromuscular
disease, and recently also in patients with type 1 diabetes. In order to allow comparisons with other studies, we also included the FSS, the MFIS, and the SF36
vitality scale.
The IPA15 was used to measure societal participation.
This self-report questionnaire measures a person's
current perception of the ability of how to live his or
her life. The questionnaire includes items such as carrying out domestic activities when one wants, and
cooking the way one prefers.15 The questionnaire consists of 32 questions. Five subscales are distinguished:
1. Autonomy indoors (five items), 2. Family role
(seven items), 3. Autonomy outdoors (seven items), 4.
Social life and relations (seven items), and 5. Work
and education (six items). The score on each IPA
domain is the average score on the items of the domain
and ranges from 0 to 4, with lower scores indicating
better societal participation and autonomy. The IPA is
a valid and reliable instrument for assessing autonomy and societal participation in chronic medical
disorders.21
The FSS is a measure of fatigue severity and comprises nine statements that are scored from 1 to 7
(1 = completely disagree; 7 = completely agree). The
final score is the mean of the item scores.16 The MFIS
is a 21-item shortened version of the Fatigue Impact
Scale; three subscales are distinguished: physical,
cognitive, and psychosocial functioning.17 Higher
scores mean a greater impact of fatigue on functioning in the specified domain.
The outcomes of the RAP and the results of the
SF36 to describe patients' daily functioning and
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Table of Contents for the Digital Edition of Multiple Sclerosis Journal - October 2017