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Narcolepsy Type 1NCT05314556

Group Psychotherapy in Narcolepsy Type 1

A study testing Group psychotherapy in people with Narcolepsy Type 1, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Narcolepsy Type 1
What is being tested?
Group psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSwitzerland
Study dates
1 Aug 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen

    Sankt Gallen, 9000

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Group psychotherapy
Keywords
Narcolepsy Type 1, Narcolepsy, Narcolepsy with cataplexy, Group psychotherapy, Group therapy, Psychotherapy
Medical subject headings
Narcolepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group psychotherapyBehavioural

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

Study groups in NCT05314556
Study groupRoleWhat they receive
InterventionExperimentalGroup psychotherapy
Receives: Behavioral: Group psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fatigue (Severity)

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

    Measured: Week 0-24

  2. Daytime sleepiness

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

    Measured: Week 0, Week 6, Week 12, Week 24

  3. Sleep quality

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

    Measured: Week 0-24

  4. Emotion regulation

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

    Measured: Week 0-24

Secondary outcomes (3)

  1. Disease processing, acceptance & coping

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

    Measured: Week 0, Week 6, Week 12, Week 24

  2. 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)

    Measured: Week 0, Week 6, Week 12, Week 24

  3. Health-related quality of life (HRQOL)

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

    Measured: Week 0-24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start1 Aug 2021
  3. Primary completion31 Mar 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314556
Sponsor's protocol ID
2021-01324
Status last verified
Feb 2023
First submitted
15 Mar 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Group psychotherapy in people with Narcolepsy Type 1, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue (Severity) (time frame: Week 0-24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314556.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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