PowerMe: Empowering children with mitochondrial disease in dealing with fatigue

Effectiveness of a blended cognitive behavioral therapy in reducing fatigue in children and adolescents with mitochondrial myopathy: The PowerMe intervention.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27650

Enrollment

Registered

2018-12-17

Start date

2019-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Mitochondrial disease, ehealth, cognitive behaviour therapy (Nederlands: mitochondriële ziekte, e-health, cognitieve gedragstherapie)

Interventions

The intervention is a blended cognitive behavior therapy targeting fatigue in children and adolescents with mitochondrial disease and severe fatigue complaints. The blended character consists of both

2) psycho-education

3) cognitive techniques

4) behavioral techniques related to energy management

5) communication skills

6) sleeping behavior and 7) relapse prevention. These CBT techniques can be useful in a wide range of possible treatment goals related to fatigue and having a mitochondrial disease.

Eligibility

Inclusion criteria

Inclusion criteria: - Age between 8 and 18 years - Able to speak, write, and read Dutch - Diagnosed with mitochondrial disease (genetically confirmed) OR suspected mitochondrial disease without genetic confirmation - Being severely fatigued (CIS fatigue higher than or equal to 35) - Access to a computer with internet connection - Basic computer skills - Able to travel to the hospital for the CBT intervention (3 sessions)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fatigue severity as measured with the Checklist Individual Strength (CIS) subscale fatigue severity (weekly).	—

Secondary

Measure	Time frame
Fatigue severity measured with the CIS subscale concentration, and the Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale (PedsQL - Fatigue) Quality of life: Child health questionnaire (CHQ); and weekly questions regarding whether fatigue has interfered with their activities during the week and how much the distress this caused School presence (attended hours/obliged hours *100); and weekly questions regarding school presence Physical functioning: CHQ subscale physical functioning Self-rated improvement: patients indicate whether they feel much better, have the same complaints or have become worse compared with the previous measurement (T0).	—

Measure

Time frame

Fatigue severity measured with the CIS subscale concentration, and the Pediatric Quality of Life Inventory - Multidimensional Fatigue Scale (PedsQL - Fatigue) Quality of life: Child health questionnaire (CHQ); and weekly questions regarding whether fatigue has interfered with their activities during the week and how much the distress this caused School presence (attended hours/obliged hours *100); and weekly questions regarding school presence Physical functioning: CHQ subscale physical functioning Self-rated improvement: patients indicate whether they feel much better, have the same complaints or have become worse compared with the previous measurement (T0).

—

Contacts

Public ContactInge-Lot Klein

Radboudumc, department Medical Psychology

Inge-Lot.Klein@radboudumc.nl+31 024 3610048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)