Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02349256
Other study ID # 123389
Secondary ID
Status Recruiting
Phase N/A
First received January 22, 2015
Last updated January 22, 2015
Start date December 2014

Study information

Verified date January 2015
Source Global Health Primary Care Research and Innovation and Network
Contact Issak Bhojani, BSc, PhD, MB
Phone 01254 617440
Email issak.bhojani@nhs.net
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical 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.


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'.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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).

Exclusion Criteria:

- individuals with diagnosed physical or learning disability

- any form of psychosis.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Shifa Surgery Blackburn

Sponsors (2)

Lead Sponsor Collaborator
Global Health Primary Care Research and Innovation and Network University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 No