Topic: Primary Care
Conditions
Interventions
Participants will be randomised to either intervention or treatment as usual (TAU) control group.
1. The intervention group will receive TAU plus up to ten sessions of CBT, tailored to
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 18 years old 2. Listed for, or considered for, total knee replacement surgery 3. Osteoarthritis of the knee 4. Reporting depression or anxiety as assessed by appropriate questionnaires
Exclusion criteria
Exclusion criteria: 1. Other co-morbid psychiatric conditions 2. Be able to speak fluent English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants identified and recruited will be recorded. The acceptability of the intervention will be determined by the number of participants who received the intervention, and from individual interviews. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of mood problems, recruitment, giving consent, completing treatments and completing outcome questionnaires. 2. The type and amount of missing data found on each questionnaire and whether this missing information could be obtained by telephone follow-up will be determined. These data will also indicate any problems of outcome questionnaires being sent by post and the ease of answering these. 3. The scores from the questionnaires to compute sample-size and power calculations for the future Phase III RCT. 4. The feasibility of using the service-use questionnaire by examining rates of completion, and fidelity of response. 5. Sensitivity analyses will be conducted to look for differences in intervention provision according to location. By recording the dates of recruitment, randomisation, and surgery, we will be able to assess how the intervention fits within the existing patient pathway. 6. Time-sampling, based on minute-by-minute coding of content, and saliency analysis of intervention transcripts to document the content and delivery of the intervention. This will help us develop the final manual for the Phase III RCT. 7. The effectiveness of the participatory research model will be evaluated through an examination of the research diaries, and through an in-depth interview with patient-partners. Measured using Western Ontario and McMaster Universities Osteoarthritis Index, Intermittent and Constant Osteoarthritis Pain scale, Beck Depression Inventory, Beck Anxiety Inventory, EQ5D, Service-use questionnaire. | — |
Countries
United Kingdom
Outcome results
None listed