- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05115604
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention
27. september 2022 oppdatert av: David Batalla-Martin
Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a Cognitive Behavioural and Psychoeducational Intervention
The study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients will be recruited by consecutive non-probabilistic sampling at the Outpatient Mental Health Centre of Nou Barris in Barcelona and subsequently randomised into 2 groups, control and intervention.
Presence and severity of insomnia will be assessed through the following measurement instruments: ISI for presence and severity, PSQI for sleep quality and EQ-5D for health-related quality of life.
Patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up.
Pre-post, 6-month and 9-month assessments will be analysed.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Catalonia
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Barcelona, Catalonia, Spania, 08027
- Nou Barris Mental Health Center
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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:
- Insomnia disorder (ISI scale)
- Schizophrenic disorder
Exclusion Criteria:
- Presence of severe psychopathological alteration
- Inability to understand the Spanish language or difficulties writing or reading
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Intrervention group
One and a half hour sessions (6 sessions) of cognitive behavioural therapy and psychoeducation.
The sessions will consist of: sleep hygiene, cognitive therapy, bedtime restriction, stimulus control and relaxation.
|
Six sessions of cognitive behavioural and psychoeducational therapy will be conducted to treat insomnia.
|
Ingen inngripen: Control group
routine clinical follow-up
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia
Tidsramme: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
|
Insomnia severity was assessed using the Insomnia Severity Index (ISI) (Morin, 1993), a self-applied instrument designed to briefly assess the severity of insomnia in the general population based on the diagnostic criteria of the DSM-IV and the ICSD.
A 5-point Likert scale is used to rate each item (0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
The total score is interpreted as follows: not clinically significant insomnia (0-7); subthreshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28) This scale has been found to have adequate psychometric properties in studies conducted using English version (Bastien et al, 2001), with internal reliability values (Cronbach's a) between 0.74 and 0.90, and test-retest reliability equal to 0.89 one month after evaluation, 0.77 two months after, and 0.73 three months after.
Two validation studies of the Spanish version of the ISI (Fernandez-Mendoza et al., 2012; Sierra et al, 2008)
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Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
|
Change in the quality of sleep, mesured with the Spanish version of The Pittsburgh Sleep Quality Index
Tidsramme: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
|
The quality of sleep has been analysed by The Pittsburgh Sleep Quality Index, which is made up of 19 self-administered questions.
The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems.
These I9 items are grouped into seven component scores, each weighted equally on a O-3 scale.
The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality (Buysse et al. 1989) .
This tool has shown in its English version acceptable measures of internal homogeneity, consistency, and validity were obtained.
A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers (Buysse et al. 1989) Tool that has been adapted in its Spanish version (Macias Fernandez and Royuela Rico 1996)
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Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in health-related quality of life , mesured with the Spanish version of EuroQol-5D Scale
Tidsramme: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
|
Health-related quality of life (HRQoL) has been assessed using the EuroQol-5D Scale (EQ-5D) (EuroQol Group 1990) a self-applied scale that is quick and easy to administer, yielding a multidimensional description of general health as well as a numerical health profile.
The scale is made up of two parts, the EQ-5D descriptive system, 5 dimensions (mobility, self- care, usual activities, pain/discomfort, and anxiety/de- pression), each with 3 levels of severity (value 1 = no problems, value 2 = some problems, value 3 = severe problems) and the visual analogue scale (EQ-VAS) (value 0 = worst and value 100 = best imaginable health status).
This scale has been validated in Spain by Xavier Badia (Badia et al. 1999).
For psychometric properties, the scale presented a test-retest reliability between 0.86 and 0.90 (van Agt et al. 1994) and a strong correlation with the SF-36 scale.
The EQ-5D scale has also been shown to be valid for use with patients with schizophrenia (Prieto et al. 2004)
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Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
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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: David Batalla-Martin, RN, MSc, Nou Barris Mental Health
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 (Faktiske)
8. april 2021
Primær fullføring (Faktiske)
20. juli 2021
Studiet fullført (Faktiske)
9. juli 2022
Datoer for studieregistrering
Først innsendt
20. oktober 2021
Først innsendt som oppfylte QC-kriteriene
30. oktober 2021
Først lagt ut (Faktiske)
10. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NBMH01/2021
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