Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000605392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
23/03/2026
Date registered
Help: Date registered
14/05/2026
Date last updated
Help: Date last updated
7/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the feasibility of psychological therapy centred on biological and social rhythms to help stabilise mood and reduce suicidal thoughts and behaviours in people with schizophrenia or schizoaffective disorder
Scientific title
Pilot single-arm feasibility study of social rhythm therapy to stabilise mood and reduce suicidality in schizophrenia and schizoaffective disorder
Additional trial identifiers [1] 316490 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Schizophrenia 340615 0
Schizoaffective Disorder 340616 0
Condition category
Condition code
Mental Health 336810 336810 0 0
Schizophrenia
Mental Health 336811 336811 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is Social Rhythm Therapy (SRT). This is an evidence-based manualised psychological therapy based on chronobiology. SRT focuses on the stabilisation of "social rhythms", which are the social relationships, social demands, and tasks that serve to entrain chronobiological rhythms. SRT focuses on teaching behavioural strategies to help stabilise and maintain healthy routines, including sleep-wake cycles, mealtimes, and physical/social activity schedules. We will use a 12-week manualised adaptation of SRT for people with schizophrenia/schizoaffective disorder, adapted from the the Social Rhythm Therapy for Bipolar manual (Crowe & Inder, 2018).

The goals of SRT are to:
• Stabilise circadian rhythms
• Regulate daily social rhythms that impact on circadian rhythms
• Develop self-awareness of psychiatric symptoms; chrono-disruptors; early warning signs and effective actions to take


SRT Session Structure

Assessment Phase (4 sessions):
- Relationship between schizophrenia/schizoaffective disorder and circadian rhythms
- Understanding of schizophrenia/schizoaffective disorder: Exploration of participants' knowledge of schizophrenia/schizoaffective disorder and the impact on them.
- Social rhythms: Review of key social rhythms (sleep patterns, exercise, activity, mealtimes). Commence recording of Social Rhythm Metric for 3 weeks to establish baseline and identify areas of unstable routines and potential target areas for intervention.
- Timeline: Identify the pattern and course of schizophrenia/schizoaffective disorder and understanding the connection between disruptions in routines and disruptions in mood.
- Brief Interpersonal Inventory: Understanding the role that relationships can have as routine disruptors and supporters.
- Clinical formulation of the participant’s problems in relation to mood and social rhythms.
- Goal setting: Facilitate an opportunity for the participant to identify focus the focus of therapy and key routines and disruptors to target.

Middle phase (6 sessions)
- Targeting problematic social rhythms and identifying strategies to establish more regular patterns.
- Impact of strategies on social rhythms and mood.
- Implementation of strategies intended to improve sleep quality.
- Implementation of strategies to stabilise social rhythms.
- Developing problem-solving skills to manage stress, chrono-disrupters and early warning signs.

Final phase (2 sessions)
- Identification of effective strategies and future situations in which they can be used.
- Review of clinical formulation and modification to reflect change and future strategies.


The SRT intervention consists of one-to-one weekly sessions of around 1 hour each. The 12-week length is based on prior SRT studies and was chosen to include time to attend to factors such as establishing therapeutic alliance and providing psychoeducation about schizophrenia/schizoaffective disorder and links to biological rhythm disruption. SRT will be delivered online (via Zoom) by a board registered psychologist (referred to here as the "clinician") who has prior experience in delivering chronobiological therapies such as SRT.

Sessions will be scheduled weekly at a time that is mutually suitable for the participant and the clinician delivering the intervention. Reminder emails will be sent to the participant the day prior to every scheduled session. If a participant does not join their scheduled session (on Zoom) within 10 minutes of the scheduled start time, the clinician will attempt to call the participant and either reschedule the session or start the zoom session. If uncontactable by phone, the clinician will email the participant to enquire if they would like to reschedule the session or discontinue participation in the study. If a participant does not attend a scheduled session for 2 consecutive weeks, they will be withdrawn from the study.
Intervention code [1] 333154 0
Treatment: Other
Intervention code [2] 333155 0
Behaviour
Intervention code [3] 333156 0
Prevention
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344819 0
Feasibility - Recruitment (composite outcome)
Timepoint [1] 344819 0
The timepoint at which 5 participants have completed the 12 week therapy course will be the primary timepoint for assessing all components of the primary outcome "Feasibility - Recruitment".
Primary outcome [2] 344822 0
Feasibility - Attrition (composite outcome)
Timepoint [2] 344822 0
Number of therapy attended sessions per participant, assessed 4 weeks following the participant's last attended session. Completeness of data collection (amount and nature of missing data post-intervention), assessed 4 weeks following the participant's last attended session. Proportion who completed intervention, assessed at the timepoint at which 5 participants have completed the full 12 week therapy course. Reasons for early drop-out (i.e. less than 12 sessions completed), assessed at the point of conducting the post-intervention interview (up to 4 weeks following the participant's last attended session).
Primary outcome [3] 344970 0
Acceptability (composite outcome)
Timepoint [3] 344970 0
Post-intervention (within 4 weeks of participant's final therapy session).
Secondary outcome [1] 459404 0
Psychological distress
Timepoint [1] 459404 0
Baseline and post-intervention (within 4 weeks of final therapy session)
Secondary outcome [2] 459405 0
Social / chronobiological rhythms
Timepoint [2] 459405 0
Baseline and post-intervention (within 4 weeks of final therapy session)
Secondary outcome [3] 459409 0
Suicidal ideation severity
Timepoint [3] 459409 0
Baseline and post-intervention (within 4 weeks of final therapy session)
Secondary outcome [4] 461170 0
Participant-reported negative incidents and effects of psychological treatment
Timepoint [4] 461170 0
Post-intervention (within 4 weeks of final therapy session)

Eligibility
Key inclusion criteria
• Have received a diagnosis from a doctor (e.g. psychiatrist) of schizophrenia or schizoaffective disorder;
• Have had experiences of suicidality (i.e. thoughts of suicide, or engaging in suicidal behaviour) at any time since receiving the above diagnosis;
• Are over 18 years of age;
• Live in Australia;
• Can attend (online via Zoom) 12 weekly therapy sessions of up to 1 hour each.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Have ever received a diagnosis of bipolar disorder.
Currently admitted to a health service (e.g. hospital) as an inpatient.
Experiencing any acute or chronic symptom/s that would limit ability to participate in the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2027
Actual
Date of last participant enrolment
Anticipated
11/08/2027
Actual
Date of last data collection
Anticipated
11/11/2027
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321101 0
Government body
Name [1] 321101 0
Suicide Prevention Australia
Country [1] 321101 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 324191 0
None
Name [1] 324191 0
Address [1] 324191 0
Country [1] 324191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319638 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 319638 0
Ethics committee country [1] 319638 0
Australia
Date submitted for ethics approval [1] 319638 0
01/04/2026
Approval date [1] 319638 0
23/09/2026
Ethics approval number [1] 319638 0
2026/HE000136

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

Contacts
Principal investigator
Name 147946 0
Dr Carl Moller
Address 147946 0
Deakin Institute for Mental and Physical Health and Clinical Translation, Health Education and Research Building, 285-299 Ryrie Street, Geelong VIC 3220
Country 147946 0
Australia
Phone 147946 0
+61 03 5227 3034
Fax 147946 0
Email 147946 0
[email protected]
Contact person for public queries
Name 147947 0
Carl Moller
Address 147947 0
Deakin Institute for Mental and Physical Health and Clinical Translation, Health Education and Research Building, 285-299 Ryrie Street, Geelong VIC 3220
Country 147947 0
Australia
Phone 147947 0
+61 03 5227 3034
Fax 147947 0
Email 147947 0
[email protected]
Contact person for scientific queries
Name 147948 0
Carl Moller
Address 147948 0
Deakin Institute for Mental and Physical Health and Clinical Translation, Health Education and Research Building, 285-299 Ryrie Street, Geelong VIC 3220
Country 147948 0
Australia
Phone 147948 0
+61 03 5227 3034
Fax 147948 0
Email 147948 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.