Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-22 @ 5:33 AM
Study NCT ID:
NCT02349256
Status:
UNKNOWN
Last Update Posted:
2015-01-28
First Post:
2015-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatoform Disorder in British South Asians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071896', 'term': 'Medically Unexplained Symptoms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative Interview', 'timeFrame': '1', 'description': 'Individual qualitative interviews with a group of British South Asians to explore their understanding of somatoform disorder and available therapies. These findings will then be used to inform the development of culturally adapted Cognitive Behaviour Therapy (CBT) for somatisation in British South Asians.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MUS', 'British South Asians', 'Somatic Symptoms', 'Qualitative interviews'], 'conditions': ['Somatic Syndrome Disorder']}, 'descriptionModule': {'briefSummary': 'The study uses in depth interviews to understand their experience of somatoform disorder, possible explanations and their experience of somatoform disorder, possible explanations and their understanding of treatments, especially their ideas about psychosocial treatments.', 'detailedDescription': '"Somatoform" or "functional" syndromes are those that present with physical symptoms, not explained by well-recognized medical illness. Such symptoms are common in all settings and studies have reported that they accounted for one-fifth of all new presentations in primary care. Literature suggests that they are associated with significant levels of psychological distress, disability, impairments in quality of life and high levels of healthcare utilization. Research also suggests that medically unexplained symptoms cause similar (or higher) levels of disability than medically explained symptoms in primary care settings. There have been a number of studies that have looked at the cognitive and behavioural basis of somatisation, and treatment strategies have been trialed based upon a cognitive behavior therapy (CBT)-led approach for these patients.\n\nIn British South Asian patients the difficulties in managing this condition are further compounded as culture can have an important role in shaping the experience, interpretation \\& clinical presentation of emotional distress. Patel reported that GPs found it very challenging to manage South Asian patients with chronic pain due to the way they present with pain, and a greater likelihood of psychosomatic presentations. Language differences as well as cultural differences contributed to the challenges, especially among first- generation South Asians. Further, they felt that self-management strategies were difficult to address. The author concludes by saying \'cultural influences play an important role in the consultation process where patients\' behaviour is often bound in their cultural view of health care. (South Asian) patients\' presentation of their condition makes diagnosis difficult but can also lead to miscommunication\'.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women self ascribed British South Asian Origin .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women of self-ascribed British South Asian origin.\n* Over the age of 18 years.\n* Able to understand spoken and written English and/or Urdu, Gujarati.\n* Able to provide written informed consent.\n* Registered with the GP practice.\n* criteria for somatoform disorder (determined by PHQ15).\n\nExclusion Criteria:\n\n* individuals with diagnosed physical or learning disability\n* any form of psychosis.'}, 'identificationModule': {'nctId': 'NCT02349256', 'briefTitle': 'Somatoform Disorder in British South Asians', 'organization': {'class': 'OTHER', 'fullName': 'Global Health Primary Care Research and Innovation and Network'}, 'officialTitle': "Somatoform Disorder in British South Asians - What Are the Patients' Views?", 'orgStudyIdInfo': {'id': '123389'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnosed with Somatic Syndrome Disorder', 'description': 'Group of participants that are screened and meet criteria for diagnosis of Somatic Syndrome disorder will be asked if they wish to take part in a 1-1 qualitative interview with the researcher.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BB1 6DY', 'city': 'Blackburn', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Issak Bhojani, BSc, PhD, MB', 'role': 'CONTACT', 'email': 'issak.bhojani@nhs.net', 'phone': '01254 617440'}, {'name': 'Saif Bhojani', 'role': 'CONTACT', 'email': 'saif.bhojani1@nhs.net', 'phone': '01254 617440'}], 'facility': 'Shifa Surgery', 'geoPoint': {'lat': 53.75, 'lon': -2.48333}}], 'centralContacts': [{'name': 'Issak Bhojani, BSc, PhD, MB', 'role': 'CONTACT', 'email': 'issak.bhojani@nhs.net', 'phone': '01254 617440'}], 'overallOfficials': [{'name': 'Saif Bhojani', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Manager'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global Health Primary Care Research and Innovation and Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}