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| ID | Type | Description | Link |
|---|---|---|---|
| 14.LO.1934 | Other Identifier | NHS research ethics committee |
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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
| University of Southampton | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerised CBT with therapist support | Experimental | 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 without therapist support | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerised Cognitive Behavioural Therapy | Behavioral | Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Chilcot, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas NHS Trust | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27458126 | Background | 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. | |
| 28992899 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 3, 2017 | |
| Reset | Aug 7, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 3, 2017 | Aug 7, 2018 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Telephone support | Behavioral | Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6. |
|
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 |
| 28985589 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |