Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Narcolepsy Type 1
- Sponsor
- Cantonal Hospital of St. Gallen
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Fatigue (Severity)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Nicolas Germann
Principal Investigator
Cantonal Hospital of St. Gallen
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Fatigue (Severity)
Time Frame: Week 0-24
German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)
Daytime sleepiness
Time Frame: Week 0, Week 6, Week 12, Week 24
German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)
Sleep quality
Time Frame: Week 0-24
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)
Emotion regulation
Time Frame: Week 0-24
German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)
Secondary Outcomes
- Disease processing, acceptance & coping(Week 0, Week 6, Week 12, Week 24)
- Anxiety & depression(Week 0, Week 6, Week 12, Week 24)
- Health-related quality of life (HRQOL)(Week 0-24)