Intervention for Improving Psychological Distress in Dialysis

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Anxiety; Depression
• Interventions: Behavioral: Computerised Cognitive Behavioural Therapy; Behavioral: Telephone support

• 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

Arm && Interventions

Group	Intervention	Description
Computerised CBT without therapist support	Computerised Cognitive Behavioural Therapy	Participants complete seven online cognitive behavioural therapy sessions weekly but do not receive any telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future
Computerised CBT with therapist support	Computerised Cognitive Behavioural Therapy	Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.
Computerised CBT with therapist support	Telephone support	Participants complete seven online cognitive behavioural therapy sessions weekly plus they receive three telephone support calls. The content of each of the sessions are summarised below: Session 1: Psycho-education about end-stage renal failure Session 2: Generation of CBT "hot cross bun" model of psychological distress Session 3: Coping strategies for managing negative emotions, including: acceptance, relaxation, expression and tips for improving sleep quality. Session 4: Identifying and challenging unhelpful thoughts Session 5: Goal setting and problem solving Session 6: Managing difficult social relationships Session 7: Progress recap and preparing for the future In addition to completing the seven online sessions the intervention arm received three 30 minute telephone support calls at weeks two, four, and six to facilitate engagement and understanding of the contents of the website.

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