Group Psychotherapy in Narcolepsy Type 1

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1

Conditions
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Narcolepsy Type 1

Intervention / Treatment
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* Behavioral: Group psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Group psychotherapy | Behavioral: Group psychotherapy<br>* Additional group psychotherapy for patients with narcolepsy type 1 with standard medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue (Severity) | German version of the questionnaire Fatigue Severity Scale (FSS; Valko et al., 2008) | Week 0-24 | 
| Daytime sleepiness | German version of the questionnaire Epworth Sleepiness Scale (ESS; Johns, 1991) | Week 0, Week 6, Week 12, Week 24 | 
| Sleep quality | German version of the questionnaire Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 2008) | Week 0-24 | 
| Emotion regulation | German questionnaire Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen (FEEL-E; Grob et al., 2014) | Week 0-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease processing, acceptance & coping | German questionnaire Freiburger Fragebogen zur Krankheitsverarbeitung (FKV-LIS-SE; Muthny, 1989) | Week 0, Week 6, Week 12, Week 24 | 
| Anxiety & depression | German version of the questionnaire Hospital Anxiety and Depression Scale (HADS; Herrmann et al., 1995; Herrmann-Lingen et al., 2011; Zigmond & Snaith, 1983) | Week 0, Week 6, Week 12, Week 24 | 
| Health-related quality of life (HRQOL) | German version of the questionnaire Short Form 12 Health Survey (SF-12; Morfeld et al., 2012) | Week 0-24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narcolepsy, Narcolepsy Type 1, Narcolepsy with cataplexy, Group psychotherapy, Group therapy, Psychotherapy