Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000899246
Ethics application status
Approved
Date submitted
21/05/2018
Date registered
29/05/2018
Date last updated
19/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Professor Marie Bashir Centre sleep program: a work-shop and ward-based program for psychiatric in-patients to improve sleep quality
Scientific title
A pilot evaluation of sleep program to improve sleep quality in acute adult psychiatric unit inpatients
Secondary ID [1] 294951 0
Nil known
Universal Trial Number (UTN)
U1111-1214-4209
Trial acronym
PSP
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Sleep quality in acute psychiatric unit 307951 0
Condition category
Condition code
Mental Health 306984 306984 0 0
Schizophrenia
Public Health 306985 306985 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nterventions
The intervention is an integrated Sleep Program. It comprises of two main components, thrice weekly group sessions and ward environmental initiatives. The overarching aim is to improve sleep through;
1. Increase daytime activity, particularly in the morning if possible, with use of the balcony and outdoor areas. It has the ultimate aim of establishing routine. Many patients in a hospital setting experience a lack of activity. For example, patients may spend a lot of time in bed watching TV or napping throughout the day.
2. Setting regular rhythms – enhanced light/dark exposure to stabilize circadian rhythms.
3. Stimulus control and relaxation – simple breathing techniques, relaxing music through headphones, relaxation on bean bags
4. Encourage patient-driven management through psychoeducation, ongoing sleep quality monitoring and feedback, and driving behavioural change in the ward milieu.
The total duration of a patient’s participation in the Program is flexible. Normally, the participation ends when a patient is discharged from Acute Unit, or a total of 6 weeks, whichever is shorter. However, we consider a 2-week duration as the minimum dose.

Ward environmental initiatives
A number of initiatives are adopted. They are specific to the participants of the study. Bean bag and visual cues (ward posters) are made available to the participants in their own rooms; while headphones are pre-existing equipment available to all patients in the Acute Unit.

Stimulus Control Therapy:

• Consistent wake time at 7am encouraged by ward staff
• Beanbags: an alternate place to sit other than the bed
Sleep Psycho-education
• Visual cues regarding specific sleep hygiene strategies around patient room and ward area.
• Reinforcement, encouragement and further psychoeducation provided by nursing staff

Increased light exposure (regulating circadian rhythm)
• Using available open spaces wherever possible enhanced with early morning retimertm blue-green light goggles for those with sleep-phase delay

Relaxation
• Calming music during wind down
• Quiet space with dim lights and beanbags





Activity Groups
Each participant will be invited to participate in thrice-per-week, 30-minute workshops in the program, which aim to provide psychoeducation about sleep, debriefing and sleep-promotion related activities. It is also aimed at increasing daytime activity and enforcing a regular circadian rhythm. This is conducted on a repeated weekly cycle as outlined below. These sessions will take place on the outdoor area of the acute unit (the balcony) where possible such that participants will receive continuous daylight exposure during these sessions. Each session will take place in mid-morning to lunchtime.

Session 1
Session 1 are on Mondays. They are facilitated by a senior Occupational Therapist and a peer-support worker and is designed to instil a routine of activity (via a Cooking group). Initial consenting and program information will be provided to a patient who is commencing. As well, actigraph watch and sleep diary will be provided to the commencing participant, allowing for ongoing record and feedback of their sleep parameters throughout their time in the program. Qualitative feedback regarding sleep will be collected during these sessions.
Session 2
Second sessions are held on Wednesdays, on the balcony of the Acute Unit. They are facilitated by two psychiatry registrars. Prior to the sessions, participants’ actigraph watches are collected and sleep data analysed by the research assistant. A visual representation of sleep duration and activity for each patient will be printed prior to the session and given to the registrars, and printouts are identifiable only by participant ids.
These sessions are held as a mini picnic with healthy snacks. During these sessions, printouts will be discussed individually with participants, especially with respect to their self-evaluation in their Sleep Diaries. This aims to increase insight and empower the participants to take a proactive role in their management.
As a group, the registrars will give further psychoeducation about sleep, with a focus on sleep hygiene, and addressing specific stimuli which affect sleep.
Wednesday sessions are also repeated in a weekly cycle. Patients in their initial and final weeks of the program will be asked to complete the Pittsburgh Sleep Quality Index, modified to reflect the quality of sleep within one week.
Session 3
Session three are held on Fridays and are repeated on a weekly basis. It is split into two components.
Firstly, the morning session is in the form of a breakfast barbeque – which is open to the entire ward to participate. Facilitators of sessions 1 and 2 are able to join. This session is an informal way for participants and clinicians to freely exchange ideas and feedback, as well as to reinforce sleep psychoeducation provided in earlier sessions.

Secondly, there will be a booster session on Friday evenings, which is self-directed by the participants and is optional. It entails participants making use of the ward measures made available to them – to enhance relaxation and stimulus control.

Measurement instrument:

An Actiwatch is provided for patients to wear continuously for the logging of sleep and activity data.
The Actiwatch is manufactured by Phillips Respironics. The watch body measures 48mm x 37mm x 14mm and weighs 30g, and it is fitted on a standard, adjustable, soft TPU watch band with titanium buckle. Measurement can be conducted reliably provided the back of the watch makes contact with skin: thus, patients are expected to wear it the same way they wear a normal watch. Patients are requested to wear the watch continuously throughout the study, and particularly throughout sleep. They are required to take the watch off once a week for charging and downloading of data, and during any leave from the ward which is greater than 30 minutes in duration.

Monitoring of fidelity and compliance:

Numerous methods are used to monitor compliance to the sleep program.
Continuity of wearing the Actiwatch is monitored directly through data collected. Attendance to the workshops is logged; overall engagement is recorded qualitatively by trained facilitators, with specific feedback sought from patients to enhance this process. Actual change in sleep behaviour and observations of sleep will be recorded by nurses; and electronic medical record for this is reviewed during the study.
Intervention code [1] 301274 0
Behaviour
Intervention code [2] 301275 0
Treatment: Other
Comparator / control treatment
This is a pilot study conducted to determine feasibility, tolerability and patient up-take in the first instance. Main comparator for this study will be historical admission length and outcomes of the patients participating in the study. The time period in which the historical data is collected will be the past five years, all of which are readily accessible on the electronic medical records.
Control group
Historical

Outcomes
Primary outcome [1] 305967 0
Sleep duration as assessed by analysis of Actigraphy watch data
Timepoint [1] 305967 0
Actigraphy data is collected continuously when the actigraphy watch is worn by the patient. Data is downloaded weekly from the watch for analysis. The maximum length of time of Actigraphy Watch is worn will be duration of Acute Unit admission, or six weeks, whichever shorter duration.
Primary outcome [2] 306049 0
Sleep efficiency as assessed by analysis of Actigraphy watch data
Timepoint [2] 306049 0
Actigraphy data is collected continuously when the actigraphy watch is worn by the patient. Data is downloaded weekly from the watch for analysis. The maximum length of time of Actigraphy Watch is worn will be duration of Acute Unit admission, or six weeks, whichever shorter duration.
Secondary outcome [1] 347132 0
Sleep quality as assessed by Pittsburgh Sleep Quality Index
Timepoint [1] 347132 0
PSQI is conducted at the beginning of the study and at the end of the patient's participation. (usually at time of discharge at Acute Unit)
Secondary outcome [2] 347133 0
To test the engagement (tolerability and practicality) with a structured Stimulus Control Therapy Program.
Measured by a qualitative feedback and satisfaction survey.
Timepoint [2] 347133 0
Qualitative feedback is collected weekly in respective activity groups outlined in Interventions.

Satisfaction survey is conducted once, at the end of a patient's participation period.

Eligibility
Key inclusion criteria
Inclusion Criteria
1. Patients 18+ years.
2. Inpatient in adult psychiatric acute unit (Missenden Acute Unit) at PMBC
3. Willingness to give informed written consent and willingness to participate to and comply with the study.
4. Literacy in English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
1. Current substance dependence.
2. Severe cognitive impairment or thought disorder that does not allow participants to consent or follow treatment instructions.
3. Recent time-zone travel (within last 1 month).
4. Not currently an inpatient at Missenden Acute Unit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size or Power Calculation
The pilot study will determine the sample size. Power calculation will be the minimum number of samples required to provide adequate power for the primary outcome. (Actigraphic changes in sleep duration)

Statistical Analysis Plan
Given the pilot study nature we will describe the sample, and the outcomes using but only use analytical techniques to estimate potential effects using difference of means within person measures in SPSS. The pilot study is unlikely to generate sufficient data points for bivariate or multivariate regression modelling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2018
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10952 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 22738 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 299536 0
Hospital
Name [1] 299536 0
Sydney Local Health District
Country [1] 299536 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown 2050
Country
Australia
Secondary sponsor category [1] 298839 0
None
Name [1] 298839 0
Address [1] 298839 0
Country [1] 298839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300435 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 300435 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
Ethics committee country [1] 300435 0
Australia
Date submitted for ethics approval [1] 300435 0
16/04/2018
Approval date [1] 300435 0
29/05/2018
Ethics approval number [1] 300435 0

Summary
Brief summary
Disturbances of sleep are prominent and have a fundamental impact on the course of psychiatric disorders . Depending on the severity of illness, sleep disturbance occurs in 30 to 80% of patients with schizophrenia, and is associated with worse psychiatric symptoms, cognitive deficits, poorer outcome, and impaired quality of life.

The main aim of this study is to explore the use of Behavioural Therapy to improve sleep. Patients who volunteer in the trial will participate in a number of daytime activities that are aimed increase their exposure to light during daylight hours. There are also a series of ward measures, such as visual cues and relaxation areas designed to enhance sleep hygiene. The aim is to determine whether these measures will patients' body to adjust to a correct sleep cycle, providing better sleep quality, use fewer as-needed sleep medication, and having shorter hospital stays.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2734 2734 0 0
/AnzctrAttachments/375149-PMBC Sleep Program Protocol v.1.0 Apr 2018.pdf (Protocol)
Attachments [2] 2735 2735 0 0
/AnzctrAttachments/375149-PMBC Sleep Program - Consent Form v.1.0 Apr 2018 .docx (Participant information/consent)

Contacts
Principal investigator
Name 83654 0
Prof Nicholas Glozier
Address 83654 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050
Country 83654 0
Australia
Phone 83654 0
+61 2 9515 1596
Fax 83654 0
Email 83654 0
[email protected]
Contact person for public queries
Name 83655 0
Prof Nicholas Glozier
Address 83655 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050
Country 83655 0
Australia
Phone 83655 0
+61 2 9515 1596
Fax 83655 0
Email 83655 0
[email protected]
Contact person for scientific queries
Name 83656 0
Dr Peter Xie
Address 83656 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown 2050
Country 83656 0
Australia
Phone 83656 0
+61 2 9515 6111
Fax 83656 0
Email 83656 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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