Intervention for Improving Psychological Distress in Dialysis

Study Overview
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Brief Summary
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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

Official Title
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Intervention for Improving Psychological Distress in Dialysis (iDiD) Feasibility Two Arm Randomised Controlled Trial: Online Cognitive Behavioural Therapy (CBT) Intervention With Therapist Support vs Online CBT Intervention Alone (no Therapist Support)

Conditions
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Kidney Failure, Chronic, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Computerised Cognitive Behavioural Therapy
* Behavioral: Telephone support


Participation Criteria
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Eligibility Criteria
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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. Evidence of addiction to alcohol or drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerised CBT with therapist support<br>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. | Behavioral: Computerised Cognitive Behavioural Therapy<br>* Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis<br>Behavioral: Telephone support<br>* Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.<br>|
| Active Comparator: Computerised CBT without therapist support<br>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 | Behavioral: Computerised Cognitive Behavioural Therapy<br>* Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) | Record the number of patients approached for screening and their consent rate | Baseline recruitment/screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment , randomisation, and retention rates | Descriptive statistics as per CONSORT flow diagram | Screening, baseline, and 12 weeks follow-up | 
| Adherence to the online intervention + telephone support calls (therapist supported arm only) | Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only) | 12 weeks follow-up | 
| PHQ-9 (A self-report 9 item measure of depression) | A self-report 9 item measure of depression | Change in depression from baseline to 12 weeks | 
| GAD-7 (A self-report 7 item measure of anxiety) | A self-report 7 item measure of anxiety | Change in anxiety from baseline to 12 weeks | 
| EQ-5D (A self-report measure of quality of life) | A self-report measure of quality of life | Baseline and 12 weeks follow-up | 
| Brief Illness Perceptions Questionnaire | A self-report measure of beliefs about illness | Baseline and 12 weeks follow-up | 
| Client Service Receipt Inventory (A self-report measure of health service utilisation) | A self-report measure of health service utilisation | Baseline and 12 weeks follow-up | 
| Satisfaction with treatment (A 2 item measure generated for the purposes of present study) | A 2 item measure generated for the purposes of present study | Baseline and 12 weeks follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility study, Randomised controlled trial, Cognitive behavioural therapy, Psychological distress, Cognitive illness representations, Common sense model