To investigate the effectiveness of (manualised) reattribution therapy in the treatment of medically unexplained symptoms (MUS) within the General Hospital

ISRCTN	ISRCTN28015467
DOI	https://doi.org/10.1186/ISRCTN28015467
Protocol serial number	N0156093329
Sponsor	Department of Health (UK)
Funder	Mersey Care NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 28/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Nigel Crompton
Scientific

Liaison Psychiatry, 10th Floor
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	To investigate the effectiveness of (manualised) reattribution therapy in the treatment of medically unexplained symptoms (MUS) within the General Hospital
Study objectives	To determine the effectiveness of reattribution therapy for patients with medically unexplained symptoms. Previous studies in primary care have indicated that there are beneficial outcomes in training general practitioners in reattribution therapy. This study aims to establish the effectiveness of the treatment itself.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Medically unexplained symptoms (MUS)
Intervention	The research will be conducted in two phases: Phase 1 - The development of a client manual that will be used as an adjunct to therapy. This will be achieved by running a small case series, interviewing 2-4 patients with medically unexplained symptoms undertaking four sessions of reattribution therapy. The manual will be developed by utilising current knowledge from the literature and the lessons learned from the case series. Phase 2 - Randomised Trial. The trial will compare a group undertaking reattribution therapy with a control group receiving treatment as usual. A baseline assessment will be taken. The treatment group will receive four sessions of reattribution therapy and will also receive an assessment 6 months after the baseline assessment. The groups will be compared according to changes in social adjustment and symptom ratings.
Intervention type	Other
Primary outcome measure(s)	1. Modified Social Adjustment Scale (primary outcome measure) 2. Illness Perception Questionnaire 3. Hospital Anxiety and Depression Scale 4. Economics Questionnaire 5. SCL-90-R (Measures psychological and somatic symptoms) 6. Number of contacts with primary and secondary health care services (derived from patient questionnaire and case notes) From the study it is anticipated that the researcher will: 1. Devise a client centred treatment manual 2. Show effectiveness of reattribution therapy
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	186
Key inclusion criteria	Four patients in initial case series and then 186 patients aged 16-64 of whom 50% (n=93) will be randomised into the treatment group and 50% into the control group (n=93). These participants will be selected from people of this age group who are referred to the Liaison Mental Health Service with medically unexplained symptoms according to physicians or surgeons.
Key exclusion criteria	Clients presenting with Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM IV) organic or psychiatric mental disorders, alcohol and drug dependance or abuse, borderline personality disorder, inability to converse fluently in English will not be included in the research.
Date of first enrolment	15/11/2000
Date of final enrolment	30/11/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Liverpool University Hospital

Liverpool
L7 8XP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan