Chronic kidney disease (CKD) and psychological adjustment to living with CKD Mental and Behavioural Disorders
Conditions
Interventions
This is a two-arm, parallel-group, randomised waitlist-controlled feasibility trial. Following informed consent and completion of baseline assessments, approximately 50 adults with chronic kidney dise
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged =18 years 2. Diagnosis of CKD 3. Access to an internet-enabled device 4. Able to engage with a self-guided, digital programme 5. Able to understand written & spoken English 6. Able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Acute kidney injury without established CKD 2. Current renal replacement therapy or previous kidney transplant 3. Receipt of structured psychological therapy within the previous three months 4. Participation in Kidney BEAM or structured exercise programme within the previous three months 5. Current severe mental illness or psychiatric instability judged to make participation unsuitable, including recent suicidal ideation, suicide attempt, or active risk requiring urgent mental health intervention 6. Severe cognitive, sensory (e.g., visual or hearing), communication, or other impairments, or medical conditions judged by the clinical team or Principal Investigator to make participation inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate measured using study data on the proportion of eligible participants who consent and are recruited throughout the recruitment period at one timepoint;Retention rate measured using study data on the proportion of participants completing the post-intervention assessment 12-weeks post randomisation at one timepoint;Outcome measure completion measured using study data on the proportion of participants completing study questionnaires 12-weeks post randomisation at one timepoint;IADJUST uptake measured using study data on the proportion of participants commencing at least one iADJUST session during the 12-week intervention period at one timepoint;IADJUST engagement measured using study data on the proportion of participants completing at least 60% of iADJUST during the 12-week intervention period at one timepoint;IADJUST full intervention completion measured using study data on the proportion of participants completing 100% of iADJUST during the 12-week intervention period at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression measured using the Patient Health Questionnaire-8 (PHQ-8) score at baseline and 12-weeks post randomisation;Anxiety measured using the Generalised Anxiety Disorder-7 (GAD-7) score at baseline and 12-weeks post randomisation;Psychological distress measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) score at baseline and 12-weeks post randomisation;Fatigue measured using the Chalder Fatigue Questionnaire (CFQ) score at baseline and 12-weeks post randomisation;Functional Impairment measured using the Work and Social Adjustment Scale (WSAS) score at baseline and 12-weeks post randomisation;Kidney BEAM uptake measured using study data on the proportion of participants registering for the Kidney BEAM programme 12-weeks post randomisation at one timepoint;Retention at final follow-up measured using the proportion of participants completing the 24-week assessment at one timepoint;Kidney BEAM engagement measured using study data on Kidney BEAM platform usage metrics at 24-weeks post randomisation;Health-related Quality of Life measured using the Short Form Health Survey (SF-12) at baseline and 12-weeks post randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactiADJUST Study
Outcome results
None listed