Group Psychotherapy in Narcolepsy Type 1

NCT ID: NCT05314556

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Narcolepsy Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group psychotherapy

Group Type EXPERIMENTAL

Group psychotherapy

Intervention Type BEHAVIORAL

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

Interventions

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Group psychotherapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Germann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dagmar A Schmid, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen

Locations

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Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2021-01324

Identifier Type: -

Identifier Source: org_study_id

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