Intervention for Improving Psychological Distress in Dialysis

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Anxiety; Depression

• Registration Number: NCT02352870
• Lead Sponsor: King's College London

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-01-28
• Study Start: 2015-02
• Study First Posted: 2015-02-02
• Status Verified: 2015-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Recruitment , randomisation, and retention rates	Screening, baseline, and 12 weeks follow-up	Descriptive statistics as per CONSORT flow diagram
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
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
EQ-5D (A self-report measure of quality of life)	Baseline and 12 weeks follow-up	A self-report measure of quality of life
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
Brief Illness Perceptions Questionnaire	Baseline and 12 weeks follow-up	A self-report measure of beliefs about illness

Trial Locations

Locations (1)

Guy's and St Thomas NHS Trust; 🇬🇧 London, United Kingdom