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Group Psychotherapy in Narcolepsy Type 1

Primary Purpose

Narcolepsy Type 1

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Group psychotherapy
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy Type 1 focused on measuring Narcolepsy Type 1, Narcolepsy, Narcolepsy with cataplexy, Group psychotherapy, Group therapy, Psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Group psychotherapy

Outcomes

Primary Outcome Measures

Fatigue (Severity)
German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)
Daytime sleepiness
German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)
Sleep quality
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)
Emotion regulation
German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)

Secondary Outcome Measures

Disease processing, acceptance & coping
German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)
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)
Health-related quality of life (HRQOL)
German version of the questionnaire "Short Form 12 Health Survey" (SF-12; Morfeld et al., 2012)

Full Information

First Posted
March 15, 2022
Last Updated
February 7, 2023
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT05314556
Brief Title
Group Psychotherapy in Narcolepsy Type 1
Official Title
Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy Type 1
Keywords
Narcolepsy Type 1, Narcolepsy, Narcolepsy with cataplexy, Group psychotherapy, Group therapy, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Group psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Group psychotherapy
Intervention Description
Additional group psychotherapy for patients with narcolepsy type 1 with standard medication
Primary Outcome Measure Information:
Title
Fatigue (Severity)
Description
German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)
Time Frame
Week 0-24
Title
Daytime sleepiness
Description
German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)
Time Frame
Week 0, Week 6, Week 12, Week 24
Title
Sleep quality
Description
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)
Time Frame
Week 0-24
Title
Emotion regulation
Description
German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)
Time Frame
Week 0-24
Secondary Outcome Measure Information:
Title
Disease processing, acceptance & coping
Description
German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)
Time Frame
Week 0, Week 6, Week 12, Week 24
Title
Anxiety & depression
Description
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Herrmann-Lingen et al., 2011; Zigmond & Snaith, 1983)
Time Frame
Week 0, Week 6, Week 12, Week 24
Title
Health-related quality of life (HRQOL)
Description
German version of the questionnaire "Short Form 12 Health Survey" (SF-12; Morfeld et al., 2012)
Time Frame
Week 0-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagmar A Schmid, Dr. med
Organizational Affiliation
Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen
City
St.Gallen
ZIP/Postal Code
9000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Group Psychotherapy in Narcolepsy Type 1

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