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)
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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London、イギリス、SE1 9RT
- Guy's and St Thomas NHS Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Recruitment , randomisation, and retention rates
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Joseph Chilcot, PhD、King's College London
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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