Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00056
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
31/12/1996
Overall trial end date
31/12/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
31/12/1996
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 8WA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (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
Basic results (scientific)
Publication list
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11388088
Publication citations
-
Results
Thomas VJ, Gruen R, Shu S, Cognitive-behavioural therapy for the management of sickle cell disease pain: identification and assessment of costs., Ethn Health, 2001, 6, 1, 59-67, doi: 10.1080/13557850123965.