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Better Sleep Trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33695128
Enrollment
60
Registered
2012-09-26
Start date
2012-11-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosis Mental and Behavioural Disorders Unspecified organic or symptomatic mental disorder

Interventions

CBT-I, The insomnia intervention will be provided in up to eight sessions over 12 weeks. The twelve week window will allow some flexibility for appointment times (DNAs are quite common in this group)

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index measured at 0,12, and 24 weeks

Secondary

MeasureTime frame
Psychotic Symptoms Rating Scale measured at 0,12, 24 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026