Development of a Cognitive-Behavioural Intervention

ISRCTN	ISRCTN17915181
DOI	https://doi.org/10.1186/ISRCTN17915181
Secondary identifying numbers	6299

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 29/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angela Beattie
Scientific

Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Email	Angela.Beattie@bristol.ac.uk

Study information

Study design	Single centre randomised interventional prevention and process of care trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Development of a cognitive-behavioural intervention to reduce the risk of foot re-ulceration in patients with diabetes
Study acronym	DRN 279
Study objectives	This is a phase 1 and 2 feasibility study which aims to develop a psychological intervention for people with diabetes. The aim is to delay or prevent the onset of further diabetic foot ulcers recurring. Phase 1 involves a qualitative design incorporating 15 interviews and one patient focus group. Phase 2 involves the exploratory trial.
Ethics approval(s)	Frenchay Research Ethics Committee approved on the 19th December 2007 (ref: 07/HO107/62)
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Diabetic Foot Ulcer Subtopic: Both; Disease: Diabetic Control
Intervention	To deliver a psychological intervention which seeks to modify coping and manage emotional distress in order to reduce the risk of reulceration. This exploratory randomised controlled trial is comprised of two groups: 1. Intervention: receive CBT intervention 2. Control: receive usual care Total duration of intervention: 13 weeks Follow up length: anticipated to last up to 6 months (subject to funding extension) Study entry: single randomisation only
Intervention type	Other
Primary outcome measure	To assess the feasibility and acceptability of the psychological intervention, measured in December 2010
Secondary outcome measures	To assess the feasibility and acceptability of the psychological intervention using: 1. Hospital Anxiety and Depression Score (HADS; 0 = not at all to 3 = most of the time) 2. Medical and Coping Modes Questionnaire (MCMQ; 1 = very much to 4 = very little) 3. Brief Illness Perception Questionnaire (BIPQ; 0 = no affect to 10 = severely affects life) 4. Profile of Mood States (POMS; 0 = not at all to 4 = extremely) 5. Work and Social Adjustment Scale (WSAS) 6. Generalised Anxiety Disorder Questionnaire (GAD-IV; 0 = no, 1 = yes) 7. 12-item short form health survey (SF-12; 1 = excellent to 5 = very poor) 8. EQ-5D (1 = no problems to 3 unable to perform usual activities) 9. Embarrassment Questionnaire (EMB-Q; 1 = strongly disagree to 5 = strongly agree) 10. Social Support Questionnaire (SSQ; 1 = never to 7 = always)
Overall study start date	10/02/2009
Completion date	19/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 30; UK sample size: 30
Key inclusion criteria	1. Patients with one or more previous ulcer, but ulcer free at the time of recruitment 2. Aged 49 - 88 years, either sex
Key exclusion criteria	Patients diagnosed with charcot foot
Date of first enrolment	10/02/2009
Date of final enrolment	19/04/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Social Medicine

Bristol
BS8 2PR
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom

Website	http://www.bris.ac.uk/
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0906-11179)

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	01/05/2012		Yes	No