The management of medically unexplained symptoms in primary care settings in Viet Nam: A clinical trial of cognitive behavior therapy

Not Applicable

• Conditions: Primary Care Patients presenting with 5 or more medically unexplained symptoms; Patients with comorbid medically unexplained symptoms and depression and/or anxiety; Mental Health - Other mental health disorders; Mental Health - Depression; Mental Health - Anxiety

• Registration Number: ACTRN12611000946910
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

(1) Screen positive on the somatisation scale of the Phan Vietnamese Rating scale defined as a SUM score above 21
(2) Report experiencing five or more medically unexplained symptoms for a period of at least 6 months.

A medically unexplained symptom is defined on the basis of at least one of the following (a) incompatibility of the clinical presentation with a known physical illness, (b) absence of relevant positive physical signs, (c) laboratory investigations not supporting a diagnosis of a physical illness.
A symptom is defined as a distinctive subjective sensation or a personal observation in relation to the body, which the patient describes as abnormal. Similar symptoms (such as pain) experienced at different anatomical sites will be counted as separate symptoms, as will different symptoms at the same anatomical site.

To elicit medically unexplained symptoms we will use the following questions until no additional symptoms are elicited:

- What are your symptoms?’
- Are there any other symptoms/problems?’

Exclusion Criteria

Patients currently receiving psychiatric care; diagnosed with psychosis, alcohol dependence, dementia or cognitive impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: number of reported MUS as recorded by non-treating Primary Care Physician[Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up];Primary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Somatisation Score[Pretreatment, Posttreatment, 3-Month Follow-Up. 6-Month Follow-Up. 12-Month Follow-Up]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: Vietnamese Psychiatric Rating Scale: Depression Score[Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up];Secondary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Anxiety Score[Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up];Secondary Outcome 3: Medical Outcomes Survey Short Form 12[Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up];WHO-QOL BREF[Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up]