CompletedNot Applicable

Intervention for Improving Psychological Distress in Dialysis

United Kingdom25 participantsStarted 2015-02

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 18 years or over and receive hospital haemodialysis three-times weekly
. 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)
. Speak English sufficiently well to engage with screening tools
. Have a basic understanding of how to use the Internet and an email address
. Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Exclusion criteria

. Hospitalised at the time of assessment or within 1 month prior to the assessment
. 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
. Severe mental health disorders, for example, psychosis, bi-polar disorder
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)

Timeframe: Baseline recruitment/screening

Trial details

NCT IDNCT02352870

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Kidney Failure, Chronic trials