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Kidney-specific psychosocial assessment and support

A single-centre prospective single-blind wait-list randomised controlled feasibility trial of the kidney-specific psychosocial assessment and support intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82492510
Enrollment
36
Registered
2021-06-07
Start date
2021-11-18
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common mental health difficulties for people with kidney disease Mental and Behavioural Disorders

Interventions

Participants will receive 6 months of the intervention and 6 months of standard care, and will be individually randomised into immediate and delayed intervention groups. The multi-component intervent

Sponsors

Royal Devon and Exeter Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above 2. Under the active care of a Nephrologist 3. Patient Health Questionnaire (PHQ)-2 score OR Generalized Anxiety Disorder (GAD-2) score =3 4. Capable of giving informed consent, completing self-report measures, and using written self-help materials in English

Exclusion criteria

Exclusion criteria: 1. Currently receiving formal psychotherapy 2. A previous diagnosis of a severe or enduring mental health problem 3. Change in antidepressant medication in the last month 4. Current substance or alcohol addiction

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate: % of those eligible and approached who have consented to study participation at 3 months 2. Retention rate: % that remain in the study until the end of follow up at 12 months

Secondary

MeasureTime frame
1. Consent to screen rate: % of those approached who consent to the screening survey at 3 months 2. Screening positivity rate: % of those screened who score 3 or more on the PHQ-2/GAD-2 at 3 months 3. Randomisation acceptability assessed through qualitative interviews. Interviews will take place at 6 months for the immediate group and 12 months for the delayed group. 4. Adherence to intervention and fidelity of intervention delivery, assessed using Assistant Psychological Practitioner self-report against a quantitative checklist and qualitative interviews with participants. Checklists and Interviews will be undertaken at 6 months for the immediate group and 12 months for the delayed group. 5. Completion of outcome measures: proportion of missing data at 0, 3, 6 and 12 months (immediate group) and 0, 6, 9 and 12 months (delayed intervention group)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026