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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001265460
Ethics application status
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Approved
Date submitted
Help: Date submitted
29/10/2025
Date registered
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14/11/2025
Date last updated
Help: Date last updated
14/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
Investigating the Effectiveness of a Sleep Intervention Among Psychiatric Patients.
Scientific title
Investigating the Effectiveness of Cognitive Behavioural Therapy for Insomnia Among Psychiatric Patients.
Additional trial identifiers [1] 315430 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chronic Insomnia 339005 0
Suicidal Ideation 339006 0
Condition category
Condition code
Mental Health 335291 335291 0 0
Suicide
Mental Health 335293 335293 0 0
Other mental health disorders
Neurological 335836 335836 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study aims to implement a brief sleep intervention (Cognitive Behavioural Therapy for Insomnia (CBT-I)) adapted for suitability with psychiatric hospital inpatients, evaluating the effectiveness of this intervention in both the reduction of insomnia symptom severity and suicidal ideation.

CBT-I components aim to address the perpetuating factors contributing to the
development and maintenance of chronic insomnia. The program will cover both cognitive (i.e., cognitive therapy) and behavioural components (i.e., stimulus control therapy), relaxation techniques, sleep hygiene and psychoeducation. Stimulus control therapy aims to re-associate the bed with sleep, rather than wakefulness or anxiety. This process occurs through minimising the use of the bed for activities other than sleep, and only going to bed when an individual feels sleepiness. The standard 'sleep restriction therapy' component of CBT-I will be removed. Additional adaptations made to a standard CBT-I program were guided by the literature on CBT-I considerations for specific comorbidities, such as schizophrenia or bipolar disorder.

The therapy session plans are outlined below:

Session 1: Introduction to CBT-I, psychoeducation about sleep and chronic insomnia, stimulus control therapy (termed Bed Equals Sleep Therapy (BEST)), sleep diary introduction.

Session 2: Addressing barriers to BEST, psychoeducation (three physiological factors that control sleep), relaxation techniques (progressive muscle relaxation activity), sleep hygiene.

Session 3: Psychoeducation (the cycle of insomnia), cognitive therapy (cognitive restructuring for unhelpful beliefs around sleep).

Session 4: Cognitive re-focusing (strategy), scheduled constructive worry time (strategy), program recap, self-management after discharge.

The program will be delivered to patients during admission to a voluntary, 100-bed mental health hospital in Perth, Western Australia. The intervention will be run in face-to-face group therapy sessions across four days (two days per week, for two weeks). Each session will last for approximately 90 minutes. In terms of therapy materials, a handout will be provided to participants during each CBT-I session. These handouts, which were designed specifically for this study, reiterate important information from the session for future reference. Groups will comprise of between 8 to 10 patients. All sessions will be delivered by trained clinical staff, with qualifications as registered psychologists or occupational therapists specialised in mental health. Allocation to intervention/control is determined by a range of clinical and practical factors, including clinical suitability, treating doctor approval, and group timing/availability. Eligible patients with significant screened insomnia symptoms are offered the CBT-I group where appropriate and feasible, while others continue with treatment as usual (control).

Clinicians will maintain an attendance register. The Homework Rating Scale II - Client Version (HRS-II) will be administered to monitor treatment adherence (see 'Outcomes' section for details). Intervention fidelity will be monitored using a session checklist, with therapists reporting any CBT-I components that were not delivered (e.g. due to time constraints).
Intervention code [1] 332099 0
Treatment: Other
Intervention code [2] 332101 0
Behaviour
Description of the comparator or control
There will be an active control group for the current study. These patients will have been screened as presenting with moderate to severe insomnia symptom severity at admission, but assigned to the control condition. This non-CBT-I group will continue with the standard program of treatment at the hospital. Treatment may include a range of therapy groups such as art therapy, relapse prevention, and stress management, in addition to individual therapy and 24/7 support from nursing staff. Additionally, the reported insomnia symptom severity will be communicated to patients’ treating psychiatrist to inform treatment planning or additional referrals.
Control group
Active

Outcomes
Primary outcome [1] 342915 0
Insomnia Symptom Severity
Timepoint [1] 342915 0
Baseline, end-of-treatment.
Primary outcome [2] 342916 0
Suicidal Ideation
Timepoint [2] 342916 0
Baseline, daily throughout admission, end-of-treatment.
Secondary outcome [1] 452680 0
Psychological Distress
Timepoint [1] 452680 0
Baseline, daily throughout admission, end-of-treatment.
Secondary outcome [2] 452681 0
Perceived Burdensomeness
Timepoint [2] 452681 0
Baseline, daily throughout admission, end-of-treatment.
Secondary outcome [3] 452682 0
Thwarted Belongingness
Timepoint [3] 452682 0
Baseline, daily throughout admission, end-of-treatment.
Secondary outcome [4] 452683 0
Wellbeing
Timepoint [4] 452683 0
Baseline, daily throughout admission, end-of-treatment.
Secondary outcome [5] 452684 0
Treatment Feasibility (composite outcome)
Timepoint [5] 452684 0
Relevant data collected at each group session, end-of-treatment.
Secondary outcome [6] 464985 0
Depression and Anxiety Symptoms
Timepoint [6] 464985 0
Baseline, end-of-treatment.
Secondary outcome [7] 464986 0
Treatment Adherence
Timepoint [7] 464986 0
End-of-treatment.

Eligibility
Key inclusion criteria
Admitted to the hospital, at least 18 years of age, clinically significant insomnia symptoms at admission (e.g., ISI score > 14), clinically stable enough to attend group sessions (per treating team), and sufficient expected length of stay to attend program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Experiencing acute substance withdrawal, diagnosed with epilepsy or seizure disorders, in current acute mania or psychosis, unable to provide informed consent.

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)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In terms of statistical analysis, Generalized Linear Mixed Models (GLMM) will be fit to the data. This analysis approach was selected based on GLMM’s ability to accommodate repeated measures and non-normally distributed outcome variables. The Group x Time interaction will be examined in these models as the primary test of differential change. For each assessment point, comparisons will be made at the between-group level. Planned analyses will include propensity score matching procedures to account for potential baseline differences between groups. Matching variables may include psychological distress, suicidal ideation severity, length of admission, and other relevant clinical or demographic characteristics associated with treatment allocation and outcomes. Random effects will be included as a participant-level random intercept, accounting for potential within-person correlation across repeated observations. The potential clustering of therapy group outcome data will be acknowledged in one version of the model tested, with the better-fitting model retained. Age, sex, diagnosis, and baseline symptom severity will be included in the models as covariates.

Sample size/Power analysis:
The minimum number of participants planned to be included in the study is 160. An a priori power analysis using Monte Carlo simulation (1000 replications) was conducted in R (‘nlme’ package). This analysis indicated that a total sample of 160 participants (80 in each condition) would provide adequate power (.80) to detect a small-to-moderate Group x Time interaction effect. This sample size corresponds to approximately 10 CBT-I groups with an average of 8 participants per group, with an equivalent number of participants allocated to the treatment-as-usual condition. Additionally, recruitment will proceed for the duration of the trial period, so that a large enough sample size is obtained to detect small effects. Given that initial screening indicates around 55% of patients at the host hospital have clinically significant insomnia symptoms, this sample size is expected to be feasible across the study period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/01/2026
Actual
10/02/2026
Date of last participant enrolment
Anticipated
1/06/2028
Actual
Date of last data collection
Anticipated
14/07/2028
Actual
Sample size
Target
160
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28585 0
Perth Clinic - West Perth
Recruitment postcode(s) [1] 44812 0
6005 - West Perth

Funding & Sponsors
Funding source category [1] 320016 0
University
Name [1] 320016 0
The University of Western Australia
Country [1] 320016 0
Australia
Funding source category [2] 320077 0
Hospital
Name [2] 320077 0
Perth Clinic
Country [2] 320077 0
Australia
Primary sponsor type
Hospital
Name
Perth Clinic
Address
Country
Australia
Secondary sponsor category [1] 322563 0
Individual
Name [1] 322563 0
Dr Michael Kyron, The University of Western Australia
Address [1] 322563 0
Country [1] 322563 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318559 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 318559 0
Ethics committee country [1] 318559 0
Australia
Date submitted for ethics approval [1] 318559 0
06/08/2025
Approval date [1] 318559 0
27/11/2025
Ethics approval number [1] 318559 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144558 0
Dr Michael Kyron
Address 144558 0
The University of Western Australia, School of Psychological Science, 35 Stirling Hwy, Crawley, WA, 6009
Country 144558 0
Australia
Phone 144558 0
+61 0404 302 835
Fax 144558 0
Email 144558 0
[email protected]
Contact person for public queries
Name 144559 0
Michael Kyron
Address 144559 0
The University of Western Australia, School of Psychological Science, 35 Stirling Hwy, Crawley, WA, 6009
Country 144559 0
Australia
Phone 144559 0
+61 0404 302 835
Fax 144559 0
Email 144559 0
[email protected]
Contact person for scientific queries
Name 144560 0
Michael Kyron
Address 144560 0
The University of Western Australia, School of Psychological Science, 35 Stirling Hwy, Crawley, WA, 6009
Country 144560 0
Australia
Phone 144560 0
+61 0404 302 835
Fax 144560 0
Email 144560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.