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Clinical Trials/ISRCTN33695128
ISRCTN33695128
Completed
未知

Better Sleep Trial: a pilot randomised controlled trial for patients with delusions and/or hallucinations

niversity of Oxford (UK)0 sites60 target enrollmentSeptember 26, 2012

Overview

Phase
未知
Intervention
Not specified
Conditions
Psychosis
Sponsor
niversity of Oxford (UK)
Enrollment
60
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 26, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Oxford (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. A current delusion and/or hallucination; scoring at least 2 on the distress scale of the PSYRATS for either a delusion or hallucination
  • 2\. The delusion and/or hallucination has persisted for at least three months
  • 3\. Clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (i.e. diagnosis of nonaffective psychosis (F2\) in the International Classification of Diseases and Diagnostic and Statistical Manual IV)
  • 4\. Sleep difficulties lasting one month or longer and an Insomnia Severity Index score of 15 or above
  • 5\. Aged between 18 and 65
  • 6\. Where changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage
  • 7\. Male or female participants

Exclusion Criteria

  • 1\. Sleep apnoea
  • 2\. A primary diagnosis of alcohol or substance dependency
  • 3\. Organic syndrome or learning disability
  • 4\. A command of spoken English inadequate for engaging in therapy
  • 5\. Currently having individual CBT (though previous CBT experience is not an exclusion criterion)

Outcomes

Primary Outcomes

Not specified

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