Narcolepsy Type 1
Conditions
Keywords
Narcolepsy Type 1, Narcolepsy, Narcolepsy with cataplexy, Group psychotherapy, Group therapy, Psychotherapy
Brief summary
The aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance.
Interventions
BEHAVIORALGroup psychotherapy
Additional group psychotherapy for patients with narcolepsy type 1 with standard medication
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 \* 062 and orexin A / hypocretin 1 * Age between 18 and 65 years * Signed informed consent * Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI\>10/h)
Exclusion criteria
* Presence of severe psychiatric comorbidity * Other psychotherapy during the study period * Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue (Severity) | Week 0-24 | German version of the questionnaire Fatigue Severity Scale (FSS; Valko et al., 2008) |
| Daytime sleepiness | Week 0, Week 6, Week 12, Week 24 | German version of the questionnaire Epworth Sleepiness Scale (ESS; Johns, 1991) |
| Sleep quality | Week 0-24 | German version of the questionnaire Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2008) |
| Emotion regulation | Week 0-24 | German questionnaire Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen (FEEL-E; Grob et al., 2014) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety & depression | Week 0, Week 6, Week 12, Week 24 | German version of the questionnaire Hospital Anxiety and Depression Scale (HADS; Herrmann et al., 1995; Herrmann-Lingen et al., 2011; Zigmond & Snaith, 1983) |
| Health-related quality of life (HRQOL) | Week 0-24 | German version of the questionnaire Short Form 12 Health Survey (SF-12; Morfeld et al., 2012) |
| Disease processing, acceptance & coping | Week 0, Week 6, Week 12, Week 24 | German questionnaire Freiburger Fragebogen zur Krankheitsverarbeitung (FKV-LIS-SE; Muthny, 1989) |
Countries
Switzerland
Outcome results
None listed