Group Psychotherapy in Narcolepsy Type 1

Not Applicable

Completed

• Conditions: Narcolepsy Type 1
• Interventions: Behavioral: Group psychotherapy

• Registration Number: NCT05314556
• Lead Sponsor: Cantonal Hospital of St. Gallen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-03-15
• Primary Completion: 2022-03-31
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Group psychotherapy	Group psychotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Disease processing, acceptance & coping	Week 0, Week 6, Week 12, Week 24	German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)
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)

Trial Locations

Locations (1)

Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen; 🇨🇭 St.Gallen, Switzerland