Group Psychotherapy in Narcolepsy Type 1

Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1

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.

Study Overview

• Status: Completed
• Conditions: Narcolepsy Type 1
• Intervention / Treatment: Behavioral: Group psychotherapy

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • St.Gallen, Switzerland, 9000
    • Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Group psychotherapy	Behavioral: Group psychotherapy; Additional group psychotherapy for patients with narcolepsy type 1 with standard medication

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Dagmar A Schmid, Dr. med, Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (ACTUAL): April 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Group therapy; Psychotherapy; Narcolepsy; Group psychotherapy; Narcolepsy Type 1; Narcolepsy with cataplexy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: 2021-01324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No