Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT04315805
Status:
UNKNOWN
Last Update Posted:
2020-03-20
First Post:
2020-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-19', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-19', 'lastUpdatePostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity: Visual Analogue Scale', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'Visual Analogue Scale ranging between 0-10 where 0 is no pain at all and 10 is worst pain'}, {'measure': 'Pain Disability', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'Change in pain disability using Pain Disability Index (PDI) with 7 item.Each item scores on 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability'}, {'measure': 'Symptoms of depression and anxiety', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'Hospital Anxiety Depression Scale with 14 item. Each item on the questionnaire is scored from 0-3 where higher score represents increased anxiety and depression levels'}], 'secondaryOutcomes': [{'measure': 'Insomnia symptoms', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'Insomnia Severity Index has seven questions each scores between 0-4. Higher score defines severity of clinical insomnia'}, {'measure': 'Mental well-being', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'The Short Warwick-Edinburgh Mental Wellbeing Scale; Minimum score: 7; maximum score: 35; higher score indicates greater level of wellbeing'}, {'measure': 'Self Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale', 'timeFrame': 'From baseline to 8-week post intervention', 'description': 'Pain Self-Efficacy Questionnaire (PSEQ)- 2 item scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Psychological Distress']}, 'descriptionModule': {'briefSummary': 'This study will be a randomized wait list controlled trial studying the efficacy of an Integrative Yoga Therapy for patients with chronic pain and psychological distress. Individualised yoga program will consist of a 8-week guided self-help program.\n\nThis study will primarily investigate whether an individually tailored yoga can be beneficial for patients suffering from chronic pain reducing pain, anxiety depression, while improving overall quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced pain for \\> 3 months\n* Experiences at least one type of psychological distress such as: depression, anxiety, insomnia or stress\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Severe medical or psychiatric conditions\n* Alcohol or substance abuse\n* Active suicidality\n* Terminal illness'}, 'identificationModule': {'nctId': 'NCT04315805', 'briefTitle': 'Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress', 'organization': {'class': 'OTHER', 'fullName': 'Aarogyam UK'}, 'officialTitle': 'Integrative Yoga Therapy for Patients With Chronic Pain and Psychological Distress', 'orgStudyIdInfo': {'id': 'AU07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Integrative Yoga Therapy', 'description': 'Integrative Yoga Therapy will be provided by yoga therapist once a week and participants will be encouraged to practice at home once or twice a day.', 'interventionNames': ['Other: Integrative Yoga Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list Control', 'description': 'Participants in waiting list will serve as control group for the intervention period. After the ftherapy group has received treatment, the same program will be offered to participants in the wait-list control group.'}], 'interventions': [{'name': 'Integrative Yoga Therapy', 'type': 'OTHER', 'description': 'Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.', 'armGroupLabels': ['Integrative Yoga Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Karyalaya', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'centralContacts': [{'name': 'Usha Solanki', 'role': 'CONTACT', 'email': 'ukaarogyam@gmail.com', 'phone': '+447448307225'}], 'overallOfficials': [{'name': 'Neha Sharma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarogyam UK'}, {'name': 'Jaydeep Joshi, BAMS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarogyam UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarogyam UK', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}