Intervention for Improving Psychological Distress in Dialysis (iDiD)
9 oktober 2017 bijgewerkt door: King's College London
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)
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
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
25
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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London, Verenigd Koninkrijk, SE1 9RT
- Guy's and St Thomas NHS Trust
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Recruitment , randomisation, and retention rates
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Joseph Chilcot, PhD, King's College London
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 februari 2015
Primaire voltooiing (Werkelijk)
1 juni 2016
Studie voltooiing (Werkelijk)
1 juni 2016
Studieregistratiedata
Eerst ingediend
22 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
28 januari 2015
Eerst geplaatst (Schatting)
2 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
9 oktober 2017
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PAHTMZA WPAH 68913
- 14.LO.1934 (Andere identificatie: NHS research ethics committee)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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