Kidney Failure, Chronic, Depression, Anxiety
Conditions
Keywords
Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model
Brief summary
To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress
Interventions
BEHAVIORALComputerised Cognitive Behavioural Therapy
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
BEHAVIORALTelephone support
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
Sponsors
National Health Service, United Kingdom
University of Southampton
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or over and receive hospital haemodialysis three-times weekly 2. Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14) 3. Speak English sufficiently well to engage with screening tools 4. Have a basic understanding of how to use the Internet and an email address 5. Have a minimum dialysis vintage of ≥3 months (electronic patient record)
Exclusion criteria
1. Hospitalised at the time of assessment or within 1 month prior to the assessment 2. Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire 3. Severe mental health disorders, for example, psychosis, bi-polar disorder 4. Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item Thoughts that you would be better off dead, or of hurting yourself will be excluded from the study. 5. Evidence of addiction to alcohol or drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) | Baseline recruitment/screening | Record the number of patients approached for screening and their consent rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the online intervention + telephone support calls (therapist supported arm only) | 12 weeks follow-up | Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only) |
| PHQ-9 (A self-report 9 item measure of depression) | Change in depression from baseline to 12 weeks | A self-report 9 item measure of depression |
| GAD-7 (A self-report 7 item measure of anxiety) | Change in anxiety from baseline to 12 weeks | A self-report 7 item measure of anxiety |
| Recruitment , randomisation, and retention rates | Screening, baseline, and 12 weeks follow-up | Descriptive statistics as per CONSORT flow diagram |
| Brief Illness Perceptions Questionnaire | Baseline and 12 weeks follow-up | A self-report measure of beliefs about illness |
| Client Service Receipt Inventory (A self-report measure of health service utilisation) | Baseline and 12 weeks follow-up | A self-report measure of health service utilisation |
| Satisfaction with treatment (A 2 item measure generated for the purposes of present study) | Baseline and 12 weeks follow-up | A 2 item measure generated for the purposes of present study |
| EQ-5D (A self-report measure of quality of life) | Baseline and 12 weeks follow-up | A self-report measure of quality of life |
Countries
United Kingdom
Outcome results
None listed