Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nigel Crompton

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0156093329

Study information

Scientific title

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/11/2000

Overall trial end date

30/11/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

186

Participant 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.

Recruitment start date

15/11/2000

Recruitment end date

30/11/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Mersey Care NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes