- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02266680
Breathing Focused Yoga in Social Anxiety Disorder
A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder
연구 개요
상세 설명
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:
- 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.
- 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
- Subjects with Social Anxiety Disorder will show significant improvement in symptoms after BFY, compared to the wait-list group.
- Improvement in quality of life scores will be significantly greater in the BFY group compared to the wait-list group.
Secondary Hypotheses
- At baseline, the fMRI indications of neural circuitry of SAD subjects will differ from that of healthy controls.
- After yoga treatment, the fMRI indications of neural circuitry of treatment responders in the SAD group will be similar to that of healthy controls.
- The presence of specific gene polymorphisms in SAD patients will predict treatment response.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M6J 1H4
- Centre for Addition and Mental Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female patients aged 18-65 years
- Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
- LSAS score of ≥50
- Absence of serious medical illness
- Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
- 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:
- Current primary diagnosis of major depressive episode, mania or psychosis
- A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
- Diagnosis of a substance abuse disorder within the prior 6 months
- Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
- Currently receiving any structured formal psychotherapy (supportive therapy is allowed)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
다른 이름들:
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간섭 없음: Waitlist Group
Waitlisted participants will receive BFY at the next available group after their waitlist period is completed
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Liebowitz 사회 불안 척도(LSAS) 총점의 변화
기간: 기준선에서 연구 종점까지(8주차)
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기준선에서 연구 종점까지(8주차)
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2차 결과 측정
결과 측정 |
기간 |
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해밀턴 우울증 평가 척도(HAM-D) 총점의 변화
기간: 기준선에서 연구 종점까지(8주차)
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기준선에서 연구 종점까지(8주차)
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Change in Clinical Global Impression Scale
기간: Baseline to study endpoint (Week 8)
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Baseline to study endpoint (Week 8)
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Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
기간: Baseline to study endpoint (Week 8)
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Baseline to study endpoint (Week 8)
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Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score
기간: Baseline to study endpoint (Week 8)
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Baseline to study endpoint (Week 8)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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