Intervention for Improving Psychological Distress in Dialysis (iDiD)
9. oktober 2017 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
25
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, SE1 9RT
- Guy's and St Thomas NHS Trust
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment , randomisation, and retention rates
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Joseph Chilcot, PhD, King's College London
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2015
Primær færdiggørelse (Faktiske)
1. juni 2016
Studieafslutning (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først indsendt
22. januar 2015
Først indsendt, der opfyldte QC-kriterier
28. januar 2015
Først opslået (Skøn)
2. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. oktober 2017
Sidst verificeret
1. september 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PAHTMZA WPAH 68913
- 14.LO.1934 (Anden identifikator: NHS research ethics committee)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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