Intervention for Improving Psychological Distress in Dialysis (iDiD)
9. oktober 2017 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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London, Storbritannia, SE1 9RT
- Guy's and St Thomas NHS Trust
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Joseph Chilcot, PhD, King's College London
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2015
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
22. januar 2015
Først innsendt som oppfylte QC-kriteriene
28. januar 2015
Først lagt ut (Anslag)
2. februar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. oktober 2017
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PAHTMZA WPAH 68913
- 14.LO.1934 (Annen identifikator: NHS research ethics committee)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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