Blended cognitive behaviour therapy for children and adolescents with mitochondrial disease targeting fatigue (PowerMe): study protocol for a multiple baseline single case experiment

Table 3 Time points of all questionnaires and other measurement instruments

	Measurements	T0	T1	Weekly	Intervention
Main outcome measures
Fatigue severity	CIS, subscale fatigue severity	C	C	C
Fatigue severity	PedsQL-MFS	C, P	C, P
Secondary outcome measures
Quality of life	CHQ	C, P	C, P
School attendance	School attendance questionnaire	C, P	C, P	P
Physical functioning	CHQ, subscale physical functioning	C, P	C, P
Physical functioning	PedsQL-MFS, subscale physical functioning	C	C
Impact on daily life	Two weekly items (see the ‘Methods/design’ section)			C
Self-rated improvement	Self-rated improvement questionnaire	C	C
Indicators for treatment goals and therapeutic guidance
Sleep problems	Sleep diary				C
Level of activity	Activity diary				C
Dysfunctional cognitions about the disease and fatigue	ICQ	C
Dysfunctional cognitions about the disease and fatigue	Self-efficacy Scale	C
Mental fatigue	CIS, subscale concentration	C	C
Parenting stress	PIP	P
Other measures
Demographic variables	Age, gender, education, physical problems, and comorbidities	P
Disease- and treatment related variables (medical record)	Diagnosis, genetic mutation, affected family members, current/past treatments, time since diagnosis
Feasibility	Questions regarding patient eligibility, response rate, willingness to participate, commitment and satisfaction with the intervention.		C, P, T
Evaluation/Feedback	A process evaluation focused on treatment integrity, feedback of the therapist and patient on: the intervention, use of the website, and blended nature of the intervention		C, P, T

Note: T0, baseline assessment; T1, post-intervention assessment; weekly, weekly measurements throughout the entire study; C, child questionnaire; P, parent questionnaire; T, therapist questionnaire

ISSN: 1745-6215