None listed
Conditions
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
Interventions
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 behav
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
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed