Development of a Cognitive-Behavioural Interventio

Completed

• Conditions: Topic: Diabetes Research Network; Diabetic Foot Ulcer Subtopic: Both; Disease: Diabetic Control; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN17915181
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Patients diagnosed with charcot foot

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the feasibility and acceptability of the psychological intervention, measured in December 2010

Secondary Outcome Measures

Name	Time	Method
To assess the feasibility and acceptability of the psychological intervention using:<br>1. Hospital Anxiety and Depression Score (HADS; 0 = not at all to 3 = most of the <br>time)<br>2. Medical and Coping Modes Questionnaire (MCMQ; 1 = very much to 4 = very little)<br>3. Brief Illness Perception Questionnaire (BIPQ; 0 = no affect to 10 = severely affects life)<br>4. Profile of Mood States (POMS; 0 = not at all to 4 = extremely)<br>5. Work and Social Adjustment Scale (WSAS)<br>6. Generalised Anxiety Disorder Questionnaire (GAD-IV; 0 = no, 1 = yes)<br>7. 12-item short form health survey (SF-12; 1 = excellent to 5 = very poor)<br>8. EQ-5D (1 = no problems to 3 unable to perform usual activities)<br>9. Embarrassment Questionnaire (EMB-Q; 1 = strongly disagree to 5 = strongly agree)<br>10. Social Support Questionnaire (SSQ; 1 = never to 7 = always)