Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Breathing Focused Yoga in Social Anxiety Disorder

18. juli 2017 opdateret af: Arun Ravindran, Centre for Addiction and Mental Health

A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder

The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life will be compared between the two groups before and after the 8 weeks.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an exploratory 8-week study with a randomized controlled, parallel group design, and will be carried out in two phases: 1) 8-week treatment phase and 2) a 3-month follow-up phase.

60 patients meeting Diagnostic and Statistical Manual IV Text Revision, (DSM-IV-TR), diagnostic criteria for social anxiety disorder will be recruited. Patients who have provided written consent, have met study criteria, and are stabilized on pharmacotherapy will be enrolled into the study.

In the treatment phase, patients will be randomized, to one of two groups 1) Breathing Focused Yoga (BFY); or 2) wait-list group.

A sub-set of 15 drug- naïve patients and matched healthy controls will undergo functional magnetic resonance imaging (fMRI) scans before and after yoga treatment.

A blood sample for genetic analysis will be taken from all SAD patients, to investigate to presence of genes linked to SAD and t treatment response.

The primary aim of the study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of SAD.

There are two secondary aims:

  1. To enhance the limited research data on the effect of treatment on neural circuitry in SAD, the investigators will also conduct fMRI scans on SAD patients and matched healthy controls pre- and post-BFY intervention.
  2. As well, to add to the literature on the genetics of SAD, the investigators will validate the links between specific gene polymorphisms and SAD that are already identified in the literature, and evaluate if they predict treatment response following BFY intervention.

Primary Hypotheses

  1. Subjects with Social Anxiety Disorder will show significant improvement in symptoms after BFY, compared to the wait-list group.
  2. Improvement in quality of life scores will be significantly greater in the BFY group compared to the wait-list group.

Secondary Hypotheses

  1. At baseline, the fMRI indications of neural circuitry of SAD subjects will differ from that of healthy controls.
  2. After yoga treatment, the fMRI indications of neural circuitry of treatment responders in the SAD group will be similar to that of healthy controls.
  3. The presence of specific gene polymorphisms in SAD patients will predict treatment response.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addition and Mental Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female patients aged 18-65 years
  2. Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
  3. LSAS score of ≥50
  4. Absence of serious medical illness
  5. Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
  6. Short-acting benzodiazepines (e.g. lorazepam 1 mg prn) and sleep medications (e.g. zopiclone 7.5 mg prn) may be used, but not within 12 hours prior to a study visit

Exclusion Criteria:

  1. Current primary diagnosis of major depressive episode, mania or psychosis
  2. A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
  3. Diagnosis of a substance abuse disorder within the prior 6 months
  4. Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
  5. Currently receiving any structured formal psychotherapy (supportive therapy is allowed)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Yoga Treatment Group
BFY will be taught by a trained yoga instructor. Group sessions will be offered twice a week for 60 minutes each (i.e., a total of 2 hours per week), for 8 weeks.
Adfærdsmæssigt: Yoga Treatment Group
The breathing focused yoga intervention is a manualized yoga protocol developed at CAMH by the Mood and Anxiety Disorders group, with yoga teacher, Ms. Tiffany Garfinkel, as the lead. BFY incorporates postures and meditation, but there is a special focus on controlled breathing at different rates, including Ujjaji or slow inhalation, exhalation and holding of breath; Bhastrika or Kapalabhati, two types of vigorous breathing with forced exhalation; and cyclical breathing or a repeated pattern of slow, moderate and fast breathing.
Andre navne:
  • Breathing Focused Yoga
Ingen indgriben: Waitlist Group
Waitlisted participants will receive BFY at the next available group after their waitlist period is completed

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring i Liebowitz Social Anxiety Scale (LSAS) Total Score
Tidsramme: Baseline til undersøgelses endepunkt (uge 8)
Baseline til undersøgelses endepunkt (uge 8)

Sekundære resultatmål

Resultatmål
Tidsramme
Ændring i Hamilton Depression Rating Scale (HAM-D) Total Score
Tidsramme: Baseline til undersøgelses endepunkt (uge 8)
Baseline til undersøgelses endepunkt (uge 8)
Change in Clinical Global Impression Scale
Tidsramme: Baseline to study endpoint (Week 8)
Baseline to study endpoint (Week 8)
Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
Tidsramme: Baseline to study endpoint (Week 8)
Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score
Tidsramme: Baseline to study endpoint (Week 8)
Baseline to study endpoint (Week 8)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre for Addiction and Mental Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

30. januar 2017

Datoer for studieregistrering

Først indsendt

7. oktober 2014

Først indsendt, der opfyldte QC-kriterier

14. oktober 2014

Først opslået (Skøn)

17. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2017

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 150/2011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Social angst

Kliniske forsøg med Yoga Treatment Group

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malaysia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner