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 |
| Secondary identifying numbers | N0156093329 |
- 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
Scientific
Liaison Psychiatry, 10th Floor
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 15/11/2000 |
| Completion date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Mersey Care NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
