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Breathing Focused Yoga in Social Anxiety Disorder

18. juli 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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 navn:
  • Breathing Focused Yoga
Ingen inngripen: Waitlist Group
Waitlisted participants will receive BFY at the next available group after their waitlist period is completed

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Endring i Liebowitz Social Anxiety Scale (LSAS) total poengsum
Tidsramme: Utgangspunkt for å studere endepunkt (uke 8)
Utgangspunkt for å studere endepunkt (uke 8)

Sekundære resultatmål

Resultatmål
Tidsramme
Endring i Hamilton Depression Rating Scale (HAM-D) total poengsum
Tidsramme: Utgangspunkt for å studere endepunkt (uke 8)
Utgangspunkt for å studere endepunkt (uke 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre for Addiction and Mental Health

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2012

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

30. januar 2017

Datoer for studieregistrering

Først innsendt

7. oktober 2014

Først innsendt som oppfylte QC-kriteriene

14. oktober 2014

Først lagt ut (Anslag)

17. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. juli 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juli 2017

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 150/2011

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