Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners
21. oktober 2019 oppdatert av: Amir H Pakpour, Qazvin University Of Medical Sciences
Insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population.
Improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors.
The study aim is to asses psychological intervention for insomnia in prisons.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
140
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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Qazvin, Iran, den islamske republikken, 3419759811
- Qazvin University of Medical Sciences
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Qazvin, Iran, den islamske republikken, 3419759811
- Social Determinants of Health Research 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
Mann
Beskrivelse
Inclusion Criteria:
- Are at least 18 years of age
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-5 Insomnia Disorder
- Can speak, understand, and write in Persian
- Male
Exclusion Criteria:
- Currently receiving psychological treatment for Insomnia
- presence of a rapidly progressing neurological or medical disorder
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: CBT
consists of eight weekly treatment sessions of 45 to 60 minutes.
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consists of eight weekly treatment sessions of 45 to 60 minutes.
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Eksperimentell: MCBT
consists of eight weekly treatment sessions of 45 to 60 minutes.
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consists of eight weekly treatment sessions of 45 to 60 minutes.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
sleep hygiene behavior
Tidsramme: changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
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A self reported measure will be used with three items to measure how many days the participants had good sleep hygiene behavior.
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changes in sleep hygiene behavior baseline , 1 month and 6 months follow-up
|
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Sleep Quality
Tidsramme: changes in sleep quality baseline , 1 month and 6 months follow-up
|
The Pittsburgh Sleep Quality Index includes seven components of subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, the use of sleep medications and day time dysfunctions provide a total score of these seven components that allows us to better understand the quality and quantity of one's sleep.
The Pittsburgh Sleep Quality Index is a self-reporting instrument consisting of nine questions designed to measure the quality of sleep disorders in a period of one month.
The scale scores range from 0 to 21, with higher scores indicating poor quality of sleep and scores less than 5 considered as high quality of sleep
|
changes in sleep quality baseline , 1 month and 6 months follow-up
|
|
Insomnia Severity Index
Tidsramme: changes in insomnia baseline , 1 month and 6 months follow-up
|
The Insomnia Severity Index is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes.
The Insomnia Severity Index assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems.
It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.Higher scores reflecting more severe sleep problems
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changes in insomnia baseline , 1 month and 6 months follow-up
|
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Sleep Logs
Tidsramme: changes in Sleep Logs , 1 month and 6 months follow-up
|
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
|
changes in Sleep Logs , 1 month and 6 months follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: changes in HADS, 1 month and 6 months follow-up
|
Hospital Anxiety and Depression Scale (HADS) questionnaire.
The HADS is a fourteen item scale.
Seven of the items relate to anxiety and seven relate to depression.
The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
|
changes in HADS, 1 month and 6 months follow-up
|
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Perceived Stress Scale (PSS)
Tidsramme: changes in PSS, 1 month and 6 months follow-up
|
The Perceived Stress Scale is the most widely used measure of global perceived stress, and is a robust predictor of health and disease.
The Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
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changes in PSS, 1 month and 6 months follow-up
|
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Mindful Attention Awareness Scale
Tidsramme: changes in MAAS, 1 month and 6 months follow-up
|
The trait Mindful Attention Awareness Scale is a 15-item scale designed to assess a core characteristic of mindfulness.
Higher scores on the Mindful Attention Awareness Scale are associated with fewer & less intense current unpleasant & negative emotional states.
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changes in MAAS, 1 month and 6 months follow-up
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|
psychological well-being
Tidsramme: changes in GHQ-12, 1 month and 6 months follow-up
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The General Health Questionnaire (GHQ-12) is a self-administered questionnaire to screen and detect individuals with a diagnosable psychiatric disorder.
The higher the General Health Questionnaire scores, the greater the degree to which the subject may suffer from a psychiatric distress
|
changes in GHQ-12, 1 month and 6 months follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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 (Forventet)
25. oktober 2019
Primær fullføring (Forventet)
30. desember 2019
Studiet fullført (Forventet)
30. april 2020
Datoer for studieregistrering
Først innsendt
19. oktober 2019
Først innsendt som oppfylte QC-kriteriene
21. oktober 2019
Først lagt ut (Faktiske)
22. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IR.QUMS.REC.1397.294
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-deling Støtteinformasjonstype
- Studieprotokoll
- Statistisk analyseplan (SAP)
- Informert samtykkeskjema (ICF)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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