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Trial registered on ANZCTR


Registration number
ACTRN12611000946910
Ethics application status
Not yet submitted
Date submitted
31/08/2011
Date registered
2/09/2011
Date last updated
2/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The management of medically unexplained symptoms in primary care settings in Viet Nam: A clinical trial of cognitive behavior therapy
Scientific title
Randomised Controlled Trial of Cognitive Behavior Therapy, Structured Care and Treatment as Usual in the management of adult primary care patients presenting with 5 or more chronic medically unexplained symptoms in Ho Chi Minh City, Vietnam
Secondary ID [1] 262968 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Care Patients presenting with 5 or more medically unexplained symptoms 270690 0
Patients with comorbid medically unexplained symptoms and depression and/or anxiety 270691 0
Condition category
Condition code
Mental Health 270864 270864 0 0
Other mental health disorders
Mental Health 270865 270865 0 0
Depression
Mental Health 270866 270866 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 arms to this trial. Arm 1: mood enhanced Cognitive Behaviour Therapy for medically unexplained symptoms. Arm 2: Structured Care. Both interventions are administered using once-weekly 30-minute sessions of one-on-one therapy with a primary care physician over 4 consultations with an option for 2 additional consultations. Arm 1, Cognitive Behaviour Therapy includes an initial ethnographic illness interview and then metaphor based cognitive restructuring to reduce abnormal illness behaviour, breathing retraining for anxiety symptoms, and activity scheduling for depression symptoms, with sleep hygiene instruction. Arm 2, Structured Care involves an initial ethnographic illness interview followed by time matched clinical sessions with a primary care physician without the CBT content
Intervention code [1] 269307 0
Treatment: Other
Comparator / control treatment
Arm 3: Treatment as Usual will involve short primary care consultations consistent with current practice within Vietnam. The duration of the study for any participant will conclude after the 12-month follow-up assessment, resulting in participation duration of 14 months.
Control group
Active

Outcomes
Primary outcome [1] 279545 0
Primary Outcome 1: number of reported MUS as recorded by non-treating Primary Care Physician
Timepoint [1] 279545 0
Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up
Primary outcome [2] 279546 0
Primary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Somatisation Score
Timepoint [2] 279546 0
Pretreatment, Posttreatment, 3-Month Follow-Up. 6-Month Follow-Up. 12-Month Follow-Up
Secondary outcome [1] 287873 0
Secondary Outcome 1: Vietnamese Psychiatric Rating Scale: Depression Score
Timepoint [1] 287873 0
Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up
Secondary outcome [2] 287874 0
Secondary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Anxiety Score
Timepoint [2] 287874 0
Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up
Secondary outcome [3] 287875 0
Secondary Outcome 3: Medical Outcomes Survey Short Form 12
Timepoint [3] 287875 0
Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up
Secondary outcome [4] 287876 0
WHO-QOL BREF
Timepoint [4] 287876 0
Pretreatment, Posttreatment, 3-Month Follow-Up, 6-Month Follow-Up, 12-Month Follow-Up

Eligibility
Key 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?’
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients currently receiving psychiatric care; diagnosed with psychosis, alcohol dependence, dementia or cognitive impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clinical trial will be undertaken in collaboration with 4 primary health care clinics in Ho Chi Minh City, Vietnam. Patients who are found to present with medically unexplained symptoms after extensive medical investigation will be invited to participate in the clinical trial. Results from an earlier population based survey suggests that up to 50% of people with MUS may have comorbid symptoms of depression and anxiety disorder.
Initial screen and referral:
Consecutive patients presenting for treatment to one of 4 primary care settings with possible MUS will be screened using the 6 month version of the PVPS somatisation scale. Patients scoring above the clinical threshold will be referred for more comprehensive assessment to one of the Primary Care Physicians working with the research project.

Expanded Assessment:
Patients referred with possible MUS, will be offered a full medical assessment that will include a consultation with the Primary Care Physician to obtain a history of the presenting complaint and other physical symptoms; a physical investigation of the presenting symptoms; a blood and urine laboratory assay to examine for markers of illness (Full blood and differential white cell; markers of inflammation [ESR/CRP]; urea/electrolytes/creatinine/calcium/magnesium; liver function; thyroid function). The cost of this consultation and associated investigations will be fully covered by the project and there with no expectation that the patient will agree to participate in the clinical trial.

Patients identified with MUS who meet the study inclusion criteria will then be provided verbal and written information about the study and invited to participate.


Allocation concealment procedures:
The entry into the study and subsequent randomization will occur by electronic communication (email) by personnel at UNSW who are independent of this treatment study, and will be conducted using a coded number system to ensure that personnel involved in patient assessment will not be aware of randomization results.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient randomization to treatment condition will be conducted using random permuted blocks within strata. Randomization will be stratified according MUS severity and comorbidity (PVPS diagnosis of depression or anxiety). Randomization will be conducted using a coded number system to ensure that personnel involved in the assessments will not be aware of randomization results. All assessments will be conducted by an assessment team blind to the treatment condition. The permuted blocks will not be clustered within clinics to reduce the possibility of staff guessing randomization protocols. All assessors will be required to rate the condition that they believe the patient has been allocated to at the completion of each assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
336
Accrual to date
Final
Recruitment outside Australia
Country [1] 3821 0
Viet Nam
State/province [1] 3821 0

Funding & Sponsors
Funding source category [1] 269773 0
Government body
Name [1] 269773 0
National Health and Medical Research Council
Country [1] 269773 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Anzac Parade
Sydney NSW 2033
Country
Australia
Secondary sponsor category [1] 268813 0
University
Name [1] 268813 0
Ho Chi Minh City University of Medicine and Pharmacy
Address [1] 268813 0
217 Hong Bang Street, Dist. 5

Ho Chi Minh City, Vietnam
Country [1] 268813 0
Viet Nam

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271731 0
Ethics committee address [1] 271731 0
Ethics committee country [1] 271731 0
Date submitted for ethics approval [1] 271731 0
06/09/2011
Approval date [1] 271731 0
Ethics approval number [1] 271731 0

Summary
Brief summary
The proposed study aims to improve the understanding of patients with 5 or more medically unexplained symptoms (MUS) by undertaking ethnographic and clinical assessments of patients presenting with MUS to one of four primary health care clinics in Ho Chi Minh City; to evaluate the treatment efficacy of interventions for MUS by undertaking a randomised control trial (RCT) and one year follow up of mood enhanced cognitive behaviour therapy (CBT), structured care (SC), and treatment as usual (TU); and in parallel, to identify the range of Vietnamese stakeholders involved in responding to MUS, and to work with the Vietnamese Ministry of Health and policy officials to enhance the value of evidence generation and policy formulation for the management of MUS
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33100 0
Address 33100 0
Country 33100 0
Phone 33100 0
Fax 33100 0
Email 33100 0
Contact person for public queries
Name 16347 0
Dr Zachary Steel
Address 16347 0
Psychiatry Research and Teaching Unit
School of Psychiatry, University NSW
Level 1, Mental Health Centre
Cnr Forbes & Campbell Streets
Liverpool Hospital
Liverpool NSW 2170
Country 16347 0
Australia
Phone 16347 0
61296164311
Fax 16347 0
61285691553
Email 16347 0
[email protected]
Contact person for scientific queries
Name 7275 0
Dr Zachary Steel
Address 7275 0
Psychiatry Research and Teaching Unit
School of Psychiatry, University NSW
Level 1, Mental Health Centre
Cnr Forbes & Campbell Streets
Liverpool Hospital
Liverpool NSW 2170
Country 7275 0
Australia
Phone 7275 0
61296164311
Fax 7275 0
61285691553
Email 7275 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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