Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000756729
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
27/05/2022
Date last updated
3/11/2022
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Behavioural Activation for depressive symptoms in young people with emerging or early psychosis: a pilot study protocol
Scientific title
Behavioural Activation for depressive symptoms in young people with emerging or early psychosis: a pilot study protocol
Secondary ID [1] 307096 0
COVID-19 Supplementary Funding Pool Scheme - Code:0702/6040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 326254 0
Depression 326255 0
Condition category
Condition code
Mental Health 323560 323560 0 0
Schizophrenia
Mental Health 323561 323561 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Behavioural Activation (BA) therapy. The treatment protocol is based on previous trials of BA for depression, the COBRA trial protocol and recommendations from the National Institute for Health and Care Excellence. The study will be conducted at a youth early psychosis service offered within a mental health youth centre located in a regional city. In the intervention group, participants will receive BA in addition to standard care. This will involve 12 sessions of BA, twice weekly, in 30-minute sessions, for six weeks. BA is administered on a one-to-one basis. BA involves collaboration between therapist and client and activities are centred around supporting the client to monitor relationships between their mood and the environment, and in commencing novel or adaptive behaviours that are aligned with goals. Attendance at 6 sessions (i.e. 50%) will be considered as an adequate ‘dose’ of the intervention. The BA therapy will be delivered in person by eight mental health clinicians at in the youth early psychosis service, who will be trained in BA techniques using the credited and established online “Professional Certificate in BA for Depression” program offered by the University of South Australia. Clinicians will complete this training program as part of the intervention. This training will consist of 5 modules undertaken over 10 weeks and will take 157 hours to complete. Clinicians will complete training one month prior to commencing BA delivery.
Intervention code [1] 323548 0
Behaviour
Intervention code [2] 323549 0
Treatment: Other
Comparator / control treatment
Control group participants will receive only routine standard care. Treatment as usual involves supportive therapy and antipsychotic medication. Family support, psycho-education, vocational therapy as well as care for physical health, may also be involved in treatment as usual. Multidisciplinary teams are involved in the delivery of standard care in the service, and usually consist of psychologists, psychiatrists, mental health nurses and social workers.
Control group
Active

Outcomes
Primary outcome [1] 331321 0
The proportion of YPEEP with clinically meaningful depression symptoms assessed by BPRS data recorded in the notes.
Timepoint [1] 331321 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Primary outcome [2] 331463 0
The proportion of clinicians that complete the BA training and the proportion deemed to be competent (calculated by dividing the number of clinicians recruited by those that complete the training and those that pass the competency assessment built into the training program).
Timepoint [2] 331463 0
Baseline (0 weeks).
Primary outcome [3] 331464 0
The proportion of eligible participants approached who agree to consent to the research, calculated by dividing the number of clients eligible to take part by the number who provide informed consent
Timepoint [3] 331464 0
Baseline (0 weeks)
Secondary outcome [1] 409504 0
Negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS).
Timepoint [1] 409504 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Secondary outcome [2] 409505 0
Psychiatric symptoms as assessed by the Brief Psychiatric Rating Scale (BPRS).
Timepoint [2] 409505 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Secondary outcome [3] 409506 0
Medication side effects as assessed by the Glasgow Antipsychotic Side-effect Scale (GASS).
Timepoint [3] 409506 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Secondary outcome [4] 409507 0
Functioning as assessed by the Work and Social Adjustment Scale (WSAS).
Timepoint [4] 409507 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Secondary outcome [5] 409987 0
Depressive symptoms as assessed by the Calgary Depression Scale for Schizophrenia (CDSS).
Timepoint [5] 409987 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.
Secondary outcome [6] 409988 0
Experiences of the intervention/trial as assessed by: semi-structured interviews undertaken with a subset of clinicians (minimum of 4) and trial participants (minimum of 12) to explore their experiences of involvement in the pilot trial.
Timepoint [6] 409988 0
3 months post-intervention
Secondary outcome [7] 409989 0
Primary outcome 4.
The proportion of YPEEP participants that complete baseline measures, complete BA treatment (calculated by dividing the number of recruited participants by the number that attend at least six sessions), and complete follow-up measures (calculated by dividing the number of randomised participants by the number that fill out the validated assessment tools at baseline and all follow ups).
Timepoint [7] 409989 0
Baseline (0 weeks), immediately post intervention (6 weeks) and 3-months post intervention.

Eligibility
Key inclusion criteria
Clients of the youth early psychosis service who are aged 15 years and older are eligible to participate if they:
1. have experienced early/emerging psychosis (for less than 5 years), received care for 1 month or more, and
are experiencing depressive symptoms [BPRS depression item score greater than or equal to 3, according to the most recent BPRS assessment conducted by clinical staff within routine clinical practice];
2. are understand the study information and communicate in English; and
3. are able to provide informed consent.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they have a primary diagnosis of substance misuse, express suicidal ideation or present a known risk to themselves/others.

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)
An external computerized randomization service which uses block randomization with random permuted block sizes will be employed to ensure appropriate allocation concealment and equal samples across intervention and control groups. The external randomisation service will hold the allocation sequence and inform the trial coordinator of participants’ group allocation via text message once baseline data has been collected from consenting participants. The trial coordinator then will inform the participant and clinician of treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An external computerized randomization service which uses block randomization with random permuted block sizes will be employed to ensure appropriate allocation concealment and equal samples across intervention and control groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Allocation will be blinded to the statistician, but it will not be masked to the clinicians and research assistants who will collect baseline, post-intervention, and follow-up outcome data.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Raw data will be entered and analysed with SPSS (the Statistical Package for the Social Sciences) for Windows, version 26. The demographic characteristics and baseline data measure (mean scores) of all participants will be compared between the two study groups, using Chi-squared test or independent samples t-test to assess the homogeneity of the two groups. The generalized estimating equation (GEE) will be employed to analyse the preliminary effects of BA across the three points (baseline, and 6-weeks and 3-months after intervention) following the intention-to-treat principle, and relevant effect sizes will be calculated. The GEE analysis will account for intra-correlated repeated outcome data and accommodate data missing at random. Feasibility data will be summarized with descriptive statistics. T-tests will be carried out to examine any significant statistical differences between the two arms on primary and secondary outcome measures at both follow-up measurements if the statistical significance of the overall treatment effect was found in the GEE analysis. We will also conduct Chi-squared test or independent samples t-tests (dependent on normality of data) to assess significant differences in baseline data measures between participants that discontinue the study and those that adhere to the study protocol/com. In all tests, the level of significance will be set at P values of < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 311402 0
University
Name [1] 311402 0
Charles Darwin University the COVID-19 Supplementary Pool Scheme (grant no. 0702/6040).
Country [1] 311402 0
Australia
Primary sponsor type
University
Name
Charles Darwin University,
Address
Charles Darwin University,
Ellengowan Dr, Casuarina,
NT 0810
Country
Australia
Secondary sponsor category [1] 312797 0
None
Name [1] 312797 0
Address [1] 312797 0
Country [1] 312797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310883 0
Charles Darwin University Human Research Ethics Committee
Ethics committee address [1] 310883 0
Ethics committee country [1] 310883 0
Australia
Date submitted for ethics approval [1] 310883 0
26/01/2022
Approval date [1] 310883 0
14/03/2022
Ethics approval number [1] 310883 0
H22003 – Behavioural Activation (BA) for Depressive Symptoms in young people with emerging or early psychosis: a pilot study

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

Contacts
Principal investigator
Name 119218 0
Prof Daniel Bressington
Address 119218 0
Blue 5, College of Nursing and Midwifery,
Charles Darwin University
Casuarina Campus,
Ellengowan Dr, Casuarina
Northern Territory, 0810
Country 119218 0
Australia
Phone 119218 0
+61 8 8946 6148
Fax 119218 0
Email 119218 0
[email protected]
Contact person for public queries
Name 119219 0
Brona Nic Giolla Easpaig
Address 119219 0
Blue 5, College of Nursing and Midwifery,
Charles Darwin University
Casuarina Campus,
Ellengowan Dr, Casuarina
Northern Territory, 0810
Country 119219 0
Australia
Phone 119219 0
+61 8 8946 6156
Fax 119219 0
Email 119219 0
[email protected]
Contact person for scientific queries
Name 119220 0
Brona Nic Giolla Easpaig
Address 119220 0
Blue 5, College of Nursing and Midwifery,
Charles Darwin University
Casuarina Campus,
Ellengowan Dr, Casuarina
Northern Territory, 0810
Country 119220 0
Australia
Phone 119220 0
+61 8 8946 6156
Fax 119220 0
Email 119220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is not permitted within the scope our ethical approval.


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
SourceTitleYear of PublicationDOI
EmbaseBehavioural activation for depressive symptoms in young people with emerging or early psychosis: A pilot study protocol.2023https://dx.doi.org/10.1371/journal.pone.0280559
N.B. These documents automatically identified may not have been verified by the study sponsor.