Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000348651p
Ethics application status
Not yet submitted
Date submitted
21/03/2023
Date registered
3/04/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-delivery of tele trial Behavioural Activation in people with negative symptoms of schizophrenia: a feasibility Randomised Controlled Trial
Scientific title
Behavioural Activation for negative symptoms in people with schizophrenia
Secondary ID [1] 308480 0
Nil none
Universal Trial Number (UTN)
Trial acronym
BANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 328290 0
Condition category
Condition code
Mental Health 325335 325335 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Behavioural Activation (BA). Our protocol was informed by a systematic review of BA as an adjunct treatment for people with negative symptoms of schizophrenia. The study will be conducted at the three rural mental health centres which provide inpatient care for people with schizophrenia. In the intervention group, patients will receive BA in addition to their usual care. This will involve up to 12 sessions of BA over 12 weeks. This will be administered on a 1-1 by the mental health worker and an expert in BA via a digital tele trial model. Each 1-1 session will last up to one hour. Each session will focus upon reviewing the previous weeks activity schedule. Worker adherence to the treatment protocol will be monitored via tele health live supervision of the conversation between the worker and the consumer from experts in BA. The workers at the thee centres will be trained to practice BA competently by completing the credited and established online "Professional Certificate in Behavioural Activation" offered by the University of South Australia. Workers will complete the training program as part of the intervention. The course consists of five modules and takes approximately 157 hours to complete. Consumers with negative symptoms will be asked to participate after the workers have completed the Professional Certificate in Behavioural Activation.

Behavioural Activation works by teaching people with the skills to schedule activity which facilitate routine, reward and new activity which promotes wellbeing. Based on our systematic review, a dose of twelve sessions of Behavioural Activation is appropriate.
Intervention code [1] 324922 0
Behaviour
Comparator / control treatment
Control group participants will receive treatment as usual. Treatment as usual involves care from a mental health worker and antipsychotic medication. This may include family support, psychoeducation, vocational therapy and physical health care. Across the three sites care is delivered by multidisciplinary teams of nurses, occupational therapists, support workers, social workers and psychiatrists.
Control group
Active

Outcomes
Primary outcome [1] 333199 0
The primary outcome will be a change in negative symptoms as assessed by the research tele-trial nurse using the Positive and Negative Syndrome Scale (PANSS).
Timepoint [1] 333199 0
The primary outcome measures will be completed at three time points (a) at baseline (0 weeks), (b) at 12 weeks post-intervention, (primary endpoint).
Secondary outcome [1] 419831 0
Level of health-related quality of life as measured by the 36-Item Short Form Health Survey questionnaire (SF 36). The SF 36 measures eight health-related domains including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotion, and mental health.
Timepoint [1] 419831 0
In this study, we will administer the SF 36 survey at two time points: (a) at baseline (0 weeks) and (b) at 12 weeks post intervention.
Secondary outcome [2] 419832 0
The PHQ 9 is a 4-point Likert-type scale (0, absent; 1, mild; 2, moderate; 3, severe) with nine items that correspond to the DSM-IV Diagnostic Criterion A symptoms for major depressive disorder.
Timepoint [2] 419832 0
The secondary outcome (depression) measures will be completed at three time points (a) at baseline (0 weeks) and (b) at 12 weeks post intervention.
Secondary outcome [3] 420146 0
We will record the number of consumers who complete BA treatment by completing an audit of the clinical notes.
Timepoint [3] 420146 0
We will collect this data at 12 weeks post intervention.

Eligibility
Key inclusion criteria
The study will comprise two groups of participants: Mental health workers and consumers with a diagnosis of schizophrenia with negative symptoms.
(a) Mental health workers
Mental health workers employed by the Flinders and Upper North, Limestone Coast, and Riverland and Coorong Local Health Networks of South Australia who complete the online training in BA and agree to participate in the study. The mental health workers may include but are not limited to, mental health nurses, social workers, support workers, and occupational therapists.
(b) Consumers with mild-to-moderate negative symptoms as determined using the Positive and Negative Symptom scale.
(i) Are aged 18 years or above.
(ii) Are receiving a mental health service from the three participating mental health sites established for the Flinders and Upper North, Limestone Coast, and the Riverland, and Coorong Local Health Networks.
(iii) Are experiencing mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS).
(iv) Understand, read, write, and speak English.
(v) Provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) Mental health workers
Mental health workers that have not completed BA training even though they may be providing mental health care service at any of the three Local Health Networks in rural South Australia.

(b) Consumers

(i) Have depressive symptoms and achieve a baseline score of 15+ on the PHQ-9 scale or acute depression and need to be seen by a psychiatrist. These people will be excluded from the study for their safety.
(ii) Express suicidal ideation or are at risk of self-harm, suicide, homicide, or present a risk to others. These potential participants will be referred to a general practitioner or mental health professional for support.
(iii) Have multiple mental health diagnoses.
(iv) Have a disorder that impedes effective communication (eg, severe sensory impairment) or experience difficulty understanding or communicating effectively in English, and interpretation services are not available.
(v) Are assessed by mental health workers as being incapable of giving informed consent to participate in the study due to their medical circumstances.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following baseline data collection from consenting consumers, the research trial nurse will insert the unique participant ID into the online randomisation service (sealedenvelope.com) and receive an email confirmation of their group allocation. The allocation sequence is retained by the service and the research tele-trial nurse is unaware of group allocation until receiving confirmation for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation will be generated by an external computerized randomisation service that uses block randomisation with random permuted block sizes to ensure appropriate allocation concealment and equal sample sizes across groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be entered and analysed descriptively. Our primary analysis is intended to determine whether conducting a subsequent fully powered RCT is feasible. Therefore, the analyses will be descriptive by exploring all feasibility outcomes and will include measures of uncertainty, such as 95% CIs. As feasibility trials are not designed to establish efficacy, we will estimate the variance of outcome measures and calculate the effect size differences (with 95% CIs) on outcome measures from baseline to both follow-up points (on an intention-to-treat basis) in both groups. Where appropriate, the generalised estimating equation (GEE) will be employed to analyse the preliminary effects of BA across the two time points (baseline and 6 weeks). The GEE analysis will account for intra-correlated repeated outcome data and accommodate data missing at random.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
5/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 312721 0
University
Name [1] 312721 0
University of South Australia
Country [1] 312721 0
Australia
Primary sponsor type
Government body
Name
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Address
SA Cluster Start-up Specialist,
SA/NT Regional Clinical Trial Co-ordinating Centre (SA/NT RCC)
Office for Research
Department for Health and Wellbeing
Clinical Collaborative/Clinical System Support & Improvement
Level 5
Citi Centre Building
11 Hindmarsh Square
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 315214 0
None
Name [1] 315214 0
Address [1] 315214 0
Country [1] 315214 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312022 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 312022 0
University of South Australia Human Research Ethics Committee
North Terrace
Adelaide
SA 5001
Ethics committee country [1] 312022 0
Australia
Date submitted for ethics approval [1] 312022 0
24/05/2023
Approval date [1] 312022 0
Ethics approval number [1] 312022 0
Ethics committee name [2] 313830 0
Central Adelaide Local Health Network HREC
Ethics committee address [2] 313830 0
Level 3, Roma Mitchell Building, 136 North Terrace, Adelaide, SA 5000
Ethics committee country [2] 313830 0
Australia
Date submitted for ethics approval [2] 313830 0
29/05/2023
Approval date [2] 313830 0
Ethics approval number [2] 313830 0

Summary
Brief summary
Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that Cognitive Behavioural Therapy (CBT) results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using Behavioural Activation (BA). This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with three rural mental health services (Flinders and Upper North Local Health Network, Riverland and Coorong Local Health Network, and Limestone Coast Local Health network) that provide mental health services for people with Serious Mental Illness.
Methods
We aim to recruit 60 consumers aged 18 years or above with negative symptoms of schizophrenia as indicated by mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS). In addition, we aim to recruit eight mental health workers from three rural mental health services in South Australia and prepare them to deliver BA to consumers of their service. Consumers will be randomised to receive BA plus usual mental health care service or usual mental health care service alone. The BA plus usual mental health care service component will involve 12 sessions of up to one hour in duration which will be delivered over 12 weeks. Our team of experts will support the mental health workers to deliver BA via telehealth supervision and structure. This also helps to ensure fidelity to the intervention. Specific BA techniques that will be applied include the identification of depressed behaviours; analysis of the triggers and consequences of depressed behaviours; monitoring of activities; development of alternative goal-orientated behaviours; scheduling of activities; and the development of alternative behavioural responses to rumination. Changes in negative symptoms of schizophrenia (primary outcome) and depression (secondary outcome) will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Changes in health-related quality of life (secondary outcome) will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. We will use the PHQ 9 and the SF36 scales to assess changes in mood and health-related quality of life, respectively. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123206 0
A/Prof Martin Jones
Address 123206 0
University of South Australia
57 Wellington Street
Mount Barker
South Australia 5251
Country 123206 0
Australia
Phone 123206 0
+61 0401198633
Fax 123206 0
Email 123206 0
[email protected]
Contact person for public queries
Name 123207 0
A/Prof Martin Jones
Address 123207 0
University of South Australia
57 Wellington Street
Mount Barker
South Australia 5251
Country 123207 0
Australia
Phone 123207 0
+61 0401198633
Fax 123207 0
Email 123207 0
[email protected]
Contact person for scientific queries
Name 123208 0
A/Prof Martin Jones
Address 123208 0
University of South Australia
57 Wellington Street
Mount Barker
South Australia 5251
Country 123208 0
Australia
Phone 123208 0
+61 0401198633
Fax 123208 0
Email 123208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We will provide de-identified data from the trial upon written request.
When will data be available (start and end dates)?
The data will be made available once the first paper has been published and will have no end date.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator. He can be contacted on
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18638Study protocol    The study protocol will be a published paper
18639Ethical approval    Ethics approval will be made available upon reques... [More Details]
18640Statistical analysis plan    The statistical analysis plan will be clearly desc... [More Details]



Results publications and other study-related documents

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