Intervention for Improving Psychological Distress in Dialysis (iDiD)
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)
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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London、英国、SE1 9RT
- Guy's and St Thomas NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Computerised CBT with therapist 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. |
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
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有源比较器：Computerised CBT without therapist support
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 |
Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
大体时间：Baseline recruitment/screening
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Record the number of patients approached for screening and their consent rate
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Baseline recruitment/screening
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Recruitment , randomisation, and retention rates
大体时间：Screening, baseline, and 12 weeks follow-up
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Descriptive statistics as per CONSORT flow diagram
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Screening, baseline, and 12 weeks follow-up
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Adherence to the online intervention + telephone support calls (therapist supported arm only)
大体时间：12 weeks follow-up
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Number of online sessions accessed and their duration + number of calls completed and their duration (therapist supported arm only)
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12 weeks follow-up
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PHQ-9 (A self-report 9 item measure of depression)
大体时间：Change in depression from baseline to 12 weeks
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A self-report 9 item measure of depression
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Change in depression from baseline to 12 weeks
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GAD-7 (A self-report 7 item measure of anxiety)
大体时间：Change in anxiety from baseline to 12 weeks
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A self-report 7 item measure of anxiety
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Change in anxiety from baseline to 12 weeks
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EQ-5D (A self-report measure of quality of life)
大体时间：Baseline and 12 weeks follow-up
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A self-report measure of quality of life
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Baseline and 12 weeks follow-up
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Brief Illness Perceptions Questionnaire
大体时间：Baseline and 12 weeks follow-up
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A self-report measure of beliefs about illness
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Baseline and 12 weeks follow-up
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Client Service Receipt Inventory (A self-report measure of health service utilisation)
大体时间：Baseline and 12 weeks follow-up
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A self-report measure of health service utilisation
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Baseline and 12 weeks follow-up
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Satisfaction with treatment (A 2 item measure generated for the purposes of present study)
大体时间：Baseline and 12 weeks follow-up
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A 2 item measure generated for the purposes of present study
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Baseline and 12 weeks follow-up
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合作者和调查者
调查人员
- 首席研究员：Joseph Chilcot, PhD、King's College London
出版物和有用的链接
一般刊物
- Hudson JL, Moss-Morris R, Game D, Carroll A, Chilcot J. Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis. J Ren Care. 2016 Dec;42(4):223-238. doi: 10.1111/jorc.12168. Epub 2016 Jul 26.
- Hudson JL, Moss-Morris R, Norton S, Picariello F, Game D, Carroll A, Spencer J, McCrone P, Hotopf M, Yardley L, Chilcot J. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial. J Psychosom Res. 2017 Nov;102:61-70. doi: 10.1016/j.jpsychores.2017.09.009. Epub 2017 Sep 21.
- Chilcot J, Hudson JL, Moss-Morris R, Carroll A, Game D, Simpson A, Hotopf M. Screening for psychological distress using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS): Initial validation of structural validity in dialysis patients. Gen Hosp Psychiatry. 2018 Jan-Feb;50:15-19. doi: 10.1016/j.genhosppsych.2017.09.007. Epub 2017 Sep 28.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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