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Trial registered on ANZCTR


Registration number
ACTRN12621001123831
Ethics application status
Approved
Date submitted
27/05/2021
Date registered
23/08/2021
Date last updated
23/05/2024
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bipolar early interventions using new digital technologies (BLEND): a feasibility trial
Scientific title
A feasibility trial evaluating the safety, acceptability and feasibility of a novel multi-component model of care for youth with Bipolar Disorder I or II.
Secondary ID [1] 302158 0
Nil
Universal Trial Number (UTN)
Trial acronym
BLEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 318804 0
Condition category
Condition code
Mental Health 316820 316820 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During the 6-months of treatment, those young people receiving the BLEND intervention will have visits with a psychiatrist, a clinical psychologist and a care clinician within the BLEND team, with the sessions occurring in-person preferably, but via telehealth if necessary. In addition, young people’s online activities will be tailored by their face to face therapist and moderated by peer workers.
Psychopharmacological interventions: The psychiatrist will assess the young people, and provide evidence based pharmacotherapeutic interventions based on a review of guidelines (Chia, 2019), along with updated evidence from the Royal Australian and New Zealand College of Psychiatrists, Clinical Practice Guideline for Mood Disorders (Malhi 2015, 2020). Pharmacotherapeutic interventions (e.g., lurasidone, lithium, or lamotrigine) as well as mental state and recovery, will be reviewed over four planned sessions with the psychiatrist over the intervention period, including liaison with their general practitioner. The sessions will last 30-60minutes and may be spaced 2-12 weeks apart.
Psychological interventions: For each young person, a clinical psychologist will provide manualised and formulation driven face-to-face cognitive behavioural therapy based on a locally developed intervention for young people experiencing bipolar disorder (Macneil 2012). The BLEND psychological intervention has particular emphases on psychoeducation for bipolar disorder and social rhythm regulation which are also targeted by online psychological therapy content (embedded within and accessed entirely through the MOST digital platform described below). Participant’s engagement in online therapeutic activities is primarily self-directed, although content can be suggested and tailored for participants by their therapist. Several domains of therapy will be delivered in a blended manner (over the digital platform and in face-to-face sessions) with the clinical psychologist tailoring online and face to face content to suit the individual. Interventions will be delivered via 10-20 (50-60min) face-to-face sessions, over 6 months. Treatment fidelity will be achieved by completion of therapy fidelity checklists and regular clinical supervision.
The Moderated Online Social Therapy (MOST): platform is an interactive, purpose built online platform designed to deliver a range of evidence-based and interactive psychosocial interventions. The modules targeting depression, anxiety, social functioning, and vocational functioning are available for all young people irrespective of whether they are in BLEND or Enhanced Standard Care. Those in the BLEND arm will also have access to modules targeting psychoeducation for Bipolar Disorder, and social rhythm therapy. The platform also includes an online social networking environment, which is moderated by peer workers. Participants are able to access psychosocial interventions on MOST 24 hours per day, 7 days per week from any internet-enabled device for the 6 months of the study period.
Relapse monitoring intervention: MOST also includes an integrated weekly self-rating tool including a) the Altman Self-Rated Mania Scale and b) self-assessment of need for additional care. For those in the BLEND arm, weekly self-rating supported by SMS prompts or phone calls from their care clinician will be utilised to identify early signs of a relapse. Responses on these questions will lead to a clinical response from the care clinician thereby promoting relapse prevention.
Intervention code [1] 318457 0
Treatment: Other
Comparator / control treatment
The control group will receive a supported version of standard care currently available in the local setting (Enhanced Standard Care or ESC). This group will receive be offered routine psychological and psychopharmacological interventions, as well as relapse prevention support. The group will also have access to a non bipolar-specific version of the digital platform digital interventions that powers BLEND. This is consistent with digital interventions are currently available in the local setting.
Control group
Active

Outcomes
Primary outcome [1] 324930 0
Safety of the BLEND and ESC models will be examined based on the number, type and severity of adverse and serious adverse events recorded within the groups. Participant self-report, clinician report and open questions regarding adverse events will be used to determine the presence of adverse events. Suicidality, an expected adverse event will be measured using the Columbia Suicide Severity Rating Scale which will be administered at all visits.
Examples of adverse events include changes in severity of depression, or emergence of suicidality.
Timepoint [1] 324930 0
Baseline, 3, & 6 months after intervention commencement
Primary outcome [2] 324940 0
Feasibility of BLEND and ESC models based on in the attendance in psychological therapy sessions as well as bipolar-specific and other digital activities completed by young people.
The MOST platform will provide data on the number of activities completed by each young person. Attendance in sessions will be measured using a resource utilisation questionnaire. The Resource Utilisation Questionnaire (RUQ) was designed by one of the associate investigators on the current trial, and has been used in previously published economic evaluations and asks participants to provide information on hospitalizations, consultations with health care providers, and other related health services utilized.
Timepoint [2] 324940 0
Baseline, 3, & 6 months after intervention commencement
Primary outcome [3] 325196 0
Acceptability as measured by composite outcomes of in-depth qualitative semi-structured interviews, assessment of individual involvement with treatment, and usage of MOST digital interventions in both BLEND and ESC arms.
The MOST platform will provide data on usage of the platform, activities completed, as well as engagement with the social networking component. An in-depth qualitative semi-structured interview will be utilised to identify the participants experience of treatment. Engagement with BLEND or ESC intervention will be measured using three items relating to ‘involvement with treatment’ from the engagement measure devised by Gillespie et al (2004).
Timepoint [3] 325196 0
Baseline, 3, & 6 months after intervention commencement
Secondary outcome [1] 395453 0
NA
Timepoint [1] 395453 0
NA

Eligibility
Key inclusion criteria
1. Age 15 to 25 years
2. Diagnosis of BD I or II
3. Ability to provide informed consent and/or have a parent or guardian provide consent
on their behalf.
4. Ability and willingness to nominate an emergency contact person, such as a close
family member
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has previously received 6-months of care through a tertiary mental health service or a multi-disciplinary team for bipolar disorder or psychosis.
2. Currently requiring tertiary mental health intervention or likely to require tertiary intervention in the next 6 months, due to high level of severity, complexity or risk.
3. Experiencing psychosis or manic episode
4. Intellectual disability that interferes with the likelihood of the participant receiving benefit from participation as judged by the treating clinician;
5. Inability to converse in, or read English. English does not have to be the young person’s primary language; Does not have access to the internet and an internet-enabled device;
6. High degree of hostility and impulsivity, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project may result in harm to the young person or other users (i.e. through interactions in the social network).
*Those experiencing a hypomanic episode will be treated, and upon remission, can be admitted to the study.


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)
The randomisation schedule will be computer-generated by a statistician independent of the study. The allocation sequence will be concealed within a web-based Research Project Management System (RPMS) that has been developed at Orygen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
It will be based on a permutated block randomisation scheme with stratification for sex at birth.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
- Acceptability of interventions and feasibility of intervention delivery: All quantitative measures will be described across both groups, with effect sizes differences between groups. Qualitative interviews (conducted between 15-16months) will be recorded, transcribed and analysed using thematic analysis methods .

- Safety: The number of serious adverse events, and adverse events will be described across groups.

- Exploratory outcomes including mediators and moderators of intervention mechanisms will be described based on changes in symptoms, functioning and course of illness.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/06/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
7/07/2022
Date of last data collection
Anticipated
7/01/2023
Actual
13/06/2023
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19557 0
Orygen Youth Health - Parkville - Parkville
Recruitment postcode(s) [1] 34035 0
3052 - Parkville
Recruitment postcode(s) [2] 34036 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 306585 0
Charities/Societies/Foundations
Name [1] 306585 0
Collie Foundation
Country [1] 306585 0
Australia
Funding source category [2] 308597 0
Other Collaborative groups
Name [2] 308597 0
Flack Trust
Country [2] 308597 0
Australia
Funding source category [3] 308598 0
Charities/Societies/Foundations
Name [3] 308598 0
Hearts and Minds Investments
Country [3] 308598 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
35 Poplar Road, Parkville, 3052, VIC
Country
Australia
Secondary sponsor category [1] 309456 0
University
Name [1] 309456 0
University of Melbourne
Address [1] 309456 0
Parkville VIC 3010
Country [1] 309456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306768 0
Office of Research Ethics and Integrity (OREI) The University of Melbourne
Ethics committee address [1] 306768 0
Parkville VIC 3010
Ethics committee country [1] 306768 0
Australia
Date submitted for ethics approval [1] 306768 0
27/10/2020
Approval date [1] 306768 0
07/12/2020
Ethics approval number [1] 306768 0
14536

Summary
Brief summary
Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder who seek care. We have developed a specialised clinical intervention model (BLEND) integrating evidence-based psychological strategies delivered through digital and face-to-face sessions; psychopharmacological interventions; relapse prevention and online social networking. We will conduct a randomised trial to evaluate the acceptability, safety and feasibility of this intervention, compared with an enhanced model of care currently delivered at the clinic (Enhanced Standard Care or ESC). We will include young people aged between 15 and 25 years, seeking specialised help for the first time for Bipolar Disorder types I or II. After informed consent, we will randomise 20 such young people (2:1) to BLEND or ESC. Interventions will be delivered over 6 months and assessments will be conducted at baseline, 3 and 6 months. This study will help adapt the intervention(s) to improve acceptability, feasibility or safety and enable the next steps in evaluating the efficacy of the BLEND model.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104958 0
Dr Aswin Ratheesh
Address 104958 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 104958 0
Australia
Phone 104958 0
+61 03 9966 9207
Fax 104958 0
Email 104958 0
[email protected]
Contact person for public queries
Name 104959 0
Dylan Hammond
Address 104959 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 104959 0
Australia
Phone 104959 0
+61 401 805 662
Fax 104959 0
Email 104959 0
[email protected]
Contact person for scientific queries
Name 104960 0
Dylan Hammond
Address 104960 0
Orygen, 35 Poplar Road, Parkville, VIC, 3052
Country 104960 0
Australia
Phone 104960 0
+61 401 805 662
Fax 104960 0
Email 104960 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?
All available data, de-identified
When will data be available (start and end dates)?
Data will be available after the main results have been published for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.


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
EmbaseThe future of digital mental health in the post-pandemic world: Evidence-based, blended, responsive and implementable.2022https://dx.doi.org/10.1177/00048674211070984
N.B. These documents automatically identified may not have been verified by the study sponsor.