Cognitive therapy for sickle cell disease (SCD) pain
| ISRCTN | ISRCTN13286032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13286032 |
| Secondary identifying numbers | REC00056 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 25/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Veronica Thomas
Scientific
Scientific
King's College London
University of London
Department of Nursing
Cornwall House
Waterloo Road
London
SE1 8WA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Painful crises are the most common manifestation of sickle cell disease and accounts for the greatest number of admissions with an average length of stay of seven days. This causes severe disruption to the educational and social aspects of life for these patients. The financial implications for the health service are also considerable. A recent analysis revealed a cost of £2.5 million per annum for South East London Health Authority. Research conducted in America revealed that pain management strategies that incorporate a psychological intervention can significantly reduce casualty visits and hospital admissions. A pilot study using cognitive therapy has been carried out to assess the feasibility of using this approach in patients with Sickle Cell Disease in London. Results have shown that patients are generally very positive about this approach and consider it to be beneficial in terms of reducing psychological distress, providing emotional support and in improving confidence levels. There was a significant reduction in the duration of hospital stay when compared to the control group. The present study seeks to extend the pilot study by evaluating of a community-based cognitive therapy intervention of the pain experience and well-being of 120 adolescents and young adults with sickle cell disease. The result of this study is likely to make significant contributions to knowledge by providing detailed information about the types of coping strategies used by patients with SCD. In addition information gained will enable us to determine whether the proposed intervention is cost effective and beneficial to a group of patients whose pain is notoriously difficult to manage. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sickle cell anaemia |
| Intervention | 1. A cognitive behavioural therapy pain management group 2. An attention placebo group 3. Non-intervention control group |
| Intervention type | Other |
| Primary outcome measure | Patient self-assessments: GHQ 30, Coping Strategies Questionnaire (CSQ), Pain Self Efficacy Questionnaire, Short Form McGill Pain Questionnaire |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/12/1996 |
| Completion date | 31/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Male and female SCD patients with the SS genotype between 15 and 26 years of age, who have had three or more admissions in the previous calendar year. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 31/12/1996 |
| Date of final enrolment | 31/12/1998 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 8WA
United Kingdom
SE1 8WA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2001 | Yes | No |
