Group Psychotherapy in Narcolepsy Type 1

Narcolepsy Type 1 Clinical Trial

Official title:

Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314556
• Other study ID #: 2021-01324
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Narcolepsy
• Narcolepsy Type 1

Intervention

Behavioral:
• Group psychotherapy
Additional group psychotherapy for patients with narcolepsy type 1 with standard medication

Locations

Country	Name	City	State
Switzerland	Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen	St.Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue (Severity)	German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)	Week 0-24
Primary	Daytime sleepiness	German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)	Week 0, Week 6, Week 12, Week 24
Primary	Sleep quality	German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)	Week 0-24
Primary	Emotion regulation	German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)	Week 0-24
Secondary	Disease processing, acceptance & coping	German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)	Week 0, Week 6, Week 12, Week 24
Secondary	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
Secondary	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