Steel 2011.

Trial name or title	The management of medically unexplained symptoms in primary care settings in Viet Nam: A clinical trial of cognitive behavior therapy
Methods	Randomised controlled trial, 3 parallel arms
Participants	Primary care participants 18‐65 yrs presenting with ≥ 5 or medically unexplained symptoms; participants with co‐morbid medically unexplained symptoms and depression and/or anxiety
Interventions	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 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
Outcomes	Primary Outcome 1: number of reported MUS as recorded by non‐treating Primary Care Physician Primary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Somatisation Score Secondary Outcome 1: Vietnamese Psychiatric Rating Scale: Depression Score Secondary Outcome 2: Phan Vietnamese Psychiatric Rating Scale: Anxiety Score Secondary Outcome 3: Medical Outcomes Survey Short Form 12 WHO‐QOL BREF
Starting date	Not yet recruiting (July 2014)
Contact information	z.steel@unsw.edu.au (Zachary Steel)
Notes	Australian Trial Register Identifier ACTRN12611000946910