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Empowering children with mitochondrial myopathy in dealing with fatigue.

Empowering children with mitochondrial myopathy in dealing with fatigue. - PowerMe study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46370
Enrollment
10
Registered
2018-08-28
Start date
2019-04-21
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

metabolic disease mitochondrial diseases oxidative phosporylation diseases

Interventions

Participants will receive blended cognitive behavioral therapy (CBT) for fatigue in addition to care as usual. The PowerMe intervention covers a period of 4 months in which the patient will have 8 m

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Age between 8 and 18 years - Able to speak, write, and read Dutch - Diagnosed with genetically confirmed mitochondrial disease - Being severely fatigued (CIS fatigue >= 35) - Access to a computer with internet connection - Basic computer skills - Able to travel to the Radboudumc for the CBT intervention (3 visits)

Exclusion criteria

Exclusion criteria: - Intellectual disability (developmental age younger than 8 years). - Primary depression (CDI >=16) or anxiety disorder (SCARED-C >= 25) - No current psychological treatment for fatigue

Design outcomes

Primary

MeasureTime frame
The primary outcome is perceived fatigue.

Secondary

MeasureTime frame
Secondary outcomes in children with mitochondrial disease are quality of life, physical functioning and school attendance.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)