NCT05314556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

March 15, 2022

Last Update Submit

February 7, 2023

Conditions

Narcolepsy Type 1

Keywords

Narcolepsy Type 1NarcolepsyNarcolepsy with cataplexyGroup psychotherapyGroup therapyPsychotherapy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Disease processing, acceptance & coping

    Week 0, Week 6, Week 12, Week 24

  • Anxiety & depression

    Week 0, Week 6, Week 12, Week 24

  • Health-related quality of life (HRQOL)

    Week 0-24

Study Arms (1)

Intervention

EXPERIMENTAL

Group psychotherapy

Behavioral: Group psychotherapy

Interventions

Group psychotherapyBEHAVIORAL

Additional group psychotherapy for patients with narcolepsy type 1 with standard medication

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

Sankt Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Dagmar A Schmid, Dr. med

    Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 6, 2022

Study Start

August 1, 2021

Primary Completion

March 31, 2022

Study Completion

December 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)