Condition category
Haematological Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
25/07/2011
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

Dr Veronica Thomas

ORCID ID

Contact details

King's College London
University of London
Department of Nursing
Cornwall House
Waterloo Road
London
SE1 8WA
United Kingdom

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11388088

Publication citations

  1. 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.

Additional files

Editorial Notes