Specialty: Renal disorders, Primary sub-specialty: Renal disorders
Conditions
Interventions
The intervention is a tailored CBT-based self-management intervention with therapist support. The purpose of this intervention is to target individuals’ fatigue beliefs and behaviours in order to fac
Sponsors
King's College London
King's College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are over 18 years of age 2. Have a confirmed ARD diagnosis 3. Are experiencing clinical levels of fatigue defined as scoring >18 on the Chalder Fatigue Questionnaire, when using the continuous scoring (Chalder et al., 1993; White et al., 2011) 4. Have full verbal and written proficiency in English 5. Receiving in-centre haemodialysis 6. Length of time on dialysis > 90 days 7. Are willing and able to take part in the study and intervention
Exclusion criteria
Exclusion criteria: 1. Do not provide informed consent or refuse to be randomised, 2. Have any known cognitive impairments 3. Have a severe mental health disorder, for example, psychosis, bipolar disorder 4. Do not have full verbal and written proficiency in English 5. Are currently receiving psychotherapy 6. Are currently participating in any other trial 7. Are failing on dialysis and approaching end of life (supportive care/palliative care pathway) 8. Have a fatigue (CFQ) score below the cut-off at the pre-randomisation assessment (spontaneous improvement after screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Descriptive data on recruitment and retention rates and willingness to be randomised 2. Degree of adherence to the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue severity is measured using the Chalder Fatigue Questionnaire (CFQ) at baseline and 3-months post-randomisation 2. Fatigue-related functional impairment is measured using the Work and Social Adjustment Scale (WSAS) at baseline and 3-months post-randomisation 3. Depression is measured using the Patient Health Questionnaire-9 (PHQ9) at baseline and 3-months post-randomisation 4. Anxiety is measured using the the Generalised Anxiety Disorder-7 (GAD7) at baseline and 3-months post-randomisation 5. Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline and 3-months post-randomisation 6. Fatigue perceptions is measured using the Brief Illness Perceptions Questionnaire (BIPQ) at baseline and 3-months post-randomisation 7. Cognitive and behavioural responses to fatigue is measured using the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ) at baseline and 3-months post-randomisation 8. Sleep hygiene behaviours is measured using the Sleep Hygiene Index (SHI) at baseline and 3-months post-randomisation 9. Physical activity as measured by the International Physical Activity Questionnaire (short-form) (IPAQ-SF) at baseline and 3-months post-randomisation 10. Patient perceptions of the acceptability and usefulness of the intervention is assessed through the qualitative interviews. Qualitative interviews will be conducted by an independent from the trial researcher with a subset of participants who received the intervention following completion of the follow-up questionnaire at 3-months post-randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactFederica Picariello
Outcome results
None listed