Somatic Syndrome DisorderNCT02349256
Somatoform Disorder in British South Asians
An observational study of Somatic Syndrome Disorder, run by Global Health Primary Care Research and Innovation and Network at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Syndrome Disorder
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women self ascribed British South Asian Origin .
Who may be able to join
- Men and women of self-ascribed British South Asian origin.
- Over the age of 18 years.
- Able to understand spoken and written English and/or Urdu, Gujarati.
- Able to provide written informed consent.
- Registered with the GP practice.
- criteria for somatoform disorder (determined by PHQ15).
Who cannot join
- individuals with diagnosed physical or learning disability
- any form of psychosis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Shifa Surgery
Blackburn, BB1 6DY
Issak Bhojani, BSc, PhD, MB, 01254 617440, issak.bhojani@nhs.net
Saif Bhojani, 01254 617440, saif.bhojani1@nhs.net
About this study
Official title: Somatoform Disorder in British South Asians - What Are the Patients' Views?
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.
Read the detailed description
"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.
In 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'.
- Conditions
- Somatic Syndrome Disorder
- Keywords
- MUS, British South Asians, Somatic Symptoms, Qualitative interviews
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with Somatic Syndrome Disorder | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Interview
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.
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Syndrome DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Health Primary Care Research and Innovation and Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Saif Bhojani, Study chair, Research Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349256
- Sponsor's protocol ID
- 123389
- Status last verified
- Jan 2015
- First submitted
- 22 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatoform Disorder in British South Asians - What Are the Patients' Views?
- ClinicalTrials.gov ID
- NCT02349256
- Acronym / sponsor ID
- 123389
- Conditions
- Somatic Syndrome Disorder
- Keywords
- MUS, British South Asians, Somatic Symptoms, Qualitative interviews
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Global Health Primary Care Research and Innovation and NetworkUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- Dec 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"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.
In 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'.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with Somatic Syndrome Disorder | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women self ascribed British South Asian Origin .
Key inclusion criteria (6 listed)
- Men and women of self-ascribed British South Asian origin.
- Over the age of 18 years.
- Able to understand spoken and written English and/or Urdu, Gujarati.
- Able to provide written informed consent.
- Registered with the GP practice.
Key exclusion criteria (2 listed)
- individuals with diagnosed physical or learning disability
- any form of psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Interview
Time frame: 1
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saif Bhojani study chair
Research Manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Somatic Syndrome Disorder, run by Global Health Primary Care Research and Innovation and Network at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Issak Bhojani, BSc, PhD, MB (01254 617440, issak.bhojani@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Interview (time frame: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.