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NCT Number: NCT05314556

Group Psychotherapy in 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.

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Key information

Conditions

Narcolepsy Type 1 Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

Sankt Gallen, 9000, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Psychotherapy

Behavioral

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

Primary outcomes

  1. Fatigue (Severity)

    Time frame: Week 0-24

    German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)

  2. Daytime sleepiness

    Time frame: Week 0, Week 6, Week 12, Week 24

    German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)

  3. Sleep quality

    Time frame: Week 0-24

    German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)

  4. Emotion regulation

    Time frame: Week 0-24

    German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)

Secondary outcomes

  1. Disease processing, acceptance & coping

    Time frame: Week 0, Week 6, Week 12, Week 24

    German questionnaire "Freiburger Fragebogen zur Krankheitsverarbeitung" (FKV-LIS-SE; Muthny, 1989)

  2. Anxiety & depression

    Time frame: Week 0, Week 6, Week 12, Week 24

    German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; Herrmann et al., 1995; Herrmann-Lingen et al., 2011; Zigmond & Snaith, 1983)

  3. Health-related quality of life (HRQOL)

    Time frame: Week 0-24

    German version of the questionnaire "Short Form 12 Health Survey" (SF-12; Morfeld et al., 2012)

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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