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The Sleep Study

Stabilising sleep for patients admitted at acute crisis to a psychiatric hospital: A single blind, pilot randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15324584
Enrollment
50
Registered
2015-09-29
Start date
2015-10-05
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Insomnia Mental and Behavioural Disorders Symptoms of insomnia

Interventions

Fifty participants will be recruited and participant allocation will occur with a ratio of 1:1. Assessments will take place at weeks 0, 2, 4 and 12 weeks. The assessor will be blind to allocation, t

Sponsors

Oxford Health NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male patients of an adult psychiatric inpatient ward 2. Self-reported symptoms of insomnia (Ie. a self-reported difficulty getting to or staying asleep) 3. Would like help to improve their sleep 4. Willing to allow his or her community care team to be notified of participation in the trial 5. Participant is willing and able to given informed consent to participate in the trial

Exclusion criteria

Exclusion criteria: 1. If at the point of screening there are plans for the patient to move to an alternative ward within the following 14 days (prior to week 2 primary end point) 2. The patient lives outside of the region covered by Oxford Health NHS Foundation Trust 3. A command of the English language inadequate for engaging in psychological therapy and comprehending the assessment measures 4. A diagnosis of a learning disability or organic syndrome (e.g. dementia)

Design outcomes

Primary

MeasureTime frame
1. Recruitment rate is measured by determining the percentage of participants admitted to the ward who are eligible and consent to take part in the study 2. Rate of uptake of therapy is measured by determining the percentage of participants who complete the intervention and percentage of sessions received from number of sessions offered 3. Accessibility of participant information sheet and informed consent is measure by patient feedback

Secondary

MeasureTime frame
1. Insomnia symptoms is measured using the Insomnia Severity Index questionnaire at weeks 0, 2, 4 and 12 2. Emotional wellbeing is measured using the Warwick Edinburgh Mental Wellbeing Scale at weeks 0, 2, 4 and 12 3. Psychiatric symptoms measured using the Positive and Negative Syndrome Scale and Young Mania Rating Scale at weeks 0, 2, 4 and 12 4. Suicidal ideation measured using the Beck Suicide Scale at weeks 0, 2, 4 and 12 5. Medication use and use of NHS care services is recorded using the Client Service Receipt Inventory at weeks 0, 2, 4 and 12 6. Health related quality of life is assessed using the EQ-5D at weeks 0, 2, 4 and 12 7. Global distress will be measured using the CORE-10 at weeks 0, 2, 4 and 12

Countries

United Kingdom

Contacts

Public ContactAlvaro Barrera

Outcome results

None listed

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