Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000864729
Ethics application status
Approved
Date submitted
10/06/2022
Date registered
17/06/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial evaluation of the benzodiazepine (information and reduction) digital health program (BDZ digital health) for people using benzodiazepines.
Scientific title
A pre-, post-intervention and 3-month follow up open trial to evaluate the effect of the BDZ digital health program on benzodiazepine usage, anxiety and depressive symptoms, and hope in Australian adults using benzodiazepines
Secondary ID [1] 307293 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Ethics approval was obtained via an amendment request (one approved on the 06/07/2022) based on the originally approved A15-006 application (ACTRN12615000479505) in 2015. This study is a follow-on study of ACTRN12615000479505 using a revised version of the BDZ digital health program in a new platform, with some additional changes to the previous evaluation assessments (e.g., removal of the 6 month follow-up).

Health condition
Health condition(s) or problem(s) studied:
Benzodiazepine dependency 326578 0
Anxiety 326649 0
Depression 326650 0
Condition category
Condition code
Mental Health 323822 323822 0 0
Addiction
Mental Health 323823 323823 0 0
Anxiety
Mental Health 323891 323891 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open trial (pre-intervention through to a 3-month follow-up assessment) will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health was specifically designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. BDZ digital health (and its revisions over the years) has been developed in collaboration with Reconnexion: a service of EACH. The Introduction module focuses on orientating the participant to the program, as well as the change process.

The five BDZ digital health core modules are:

1. Benzodiazepines and Dependence: This module provides psycho-education around what BDZs are, dependency on BDZ, BDZ effectiveness and appropriate and inappropriate uses of BDZ.
2. Pathway to Reduction: This module provides psycho-education on BDZ reduction and withdrawal processes, involving the 3 main steps in the BDZ reduction process
3. Gradual Reduction: Examples. This third module provides two illustrative case examples of ‘Sarah’ and ‘John’ outlining their respective gradual benzodiazepine reduction programs over time.
4. Withdrawal Symptoms. This module provides information around what BDZ related withdrawal symptoms are, common and uncommon withdrawal symptoms, and the issues with going ‘cold turkey’.
5. Managing Withdrawal Symptoms: This module contains information and helpful strategies to help manage the reduction/withdrawal symptoms (e.g., controlled breathing, progressive muscle relaxation, compassionate meditation, problem-solving, goal-setting, increasing physical exercise, gratitude, better sleep habits).

All modules are open from the first log in and each module will take approximately 20 minutes to complete. Participants are encouraged to first read the Introduction module and then work through the other modules at their own pace, over the five weeks. Given the open access nature of the program modules, participants are free to choose whether they work through the modules sequentially or not. Participants will receive weekly automated emails (e.g., to log on) and when to complete the ‘during’, post intervention and follow-up scheduled assessment questionnaires. Modules make use of text, graphics, audio, video, gif animations, editable forms, interactive games, quizzes and downloads. There is also an automated digital conversational agent (ALEX), whose goal is to try and increase motivation levels in those participants who are finding it difficult to complete any BDZ digital health module. ALEX will automatically pop-up once per module and is also accessible by pressing a floating icon on the BDZ digital health module pages (after being introduced in the Introduction module). Modules can be accessible via web, mobile or tablet devices. We also encourage participants to make use of the Reconnexion Benzodiazepine telephone support service while undertaking the BDZ digital health program, as well as work in conjunction with their doctor should they wish to commence benzodiazepine reduction.

The BDZ digital health program is housed within the participant's ‘HealthZone’ dashboard. HealthZone is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, and My Profile.

Participants will complete a pre-intervention assessment (Week 0), ‘during’ intervention (Week 3) assessment, a post-intervention assessment (Week 6) and a 6-month follow-up assessment (Week 18). While the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the BDZ digital health program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). Participants will retain access to the program until Week 26 (8 weeks past the 3-month follow-up assessment).

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / modules they visited / used and when), as well as reviewing the module review questions submitted, completion of daily mood and lifestyle survey and scheduled intervention assessments.
Intervention code [1] 323737 0
Behaviour
Intervention code [2] 323738 0
Prevention
Intervention code [3] 323741 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331612 0
Benzodiazepine dependency will be measured by the Benzodiazepine Dependence Questionnaire.
Timepoint [1] 331612 0
Pre-intervention (Week 0), post-intervention (Week 6), & 3 month follow-up (Week 18, primary endpoint) assessment.
Primary outcome [2] 331708 0
Anxiety will be measured by the Generalised Anxiety Disorder-7 survey.
Timepoint [2] 331708 0
Pre-intervention (Week 0), during intervention (Week 3), post intervention (Week 6, primary endpoint), and 3 month follow-up (Week 18).
Primary outcome [3] 332170 0
Self-reported benzodiazepine medication use via online questions (Type & Dose)
Timepoint [3] 332170 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [1] 410529 0
Depressive symptoms will be measured using the Patient Health Questionnaire-8
Timepoint [1] 410529 0
Pre-intervention (Week 0), during intervention (Week 3), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [2] 410530 0
Hope as measured by the Adult Hope Scale
Timepoint [2] 410530 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [3] 410531 0
Mental wellness will be measured using the Mental Health Contiuum - Short Form
Timepoint [3] 410531 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [4] 410532 0
Emotional regulation will be measured using the Difficulties in Emotional Regulation Scale - Brief
Timepoint [4] 410532 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [5] 410533 0
Sleep will be measured using the Insomnia Severity Index
Timepoint [5] 410533 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [6] 410534 0
Quality of life will be measured by using the EuroQual-5 (EQ-5D)
Timepoint [6] 410534 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [7] 410537 0
Treatment satisfaction, including engagement, will be measured using the Treatment Satisfaction Questionnaire.
Timepoint [7] 410537 0
Post intervention (Week 6)
Secondary outcome [8] 410538 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [8] 410538 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [9] 410539 0
Alcohol consumption levels (self-developed questions) and followed up with the CAGE Adapted to Include Drugs (CAGE-AID) Questionnaire, if high alcohol consumption is indicated.
Timepoint [9] 410539 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [10] 410540 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [10] 410540 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [11] 410544 0
Use of services for a physical health condition questions (self developed)
Timepoint [11] 410544 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [12] 410545 0
Use of mental health services questions (self developed)
Timepoint [12] 410545 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [13] 410546 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [13] 410546 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [14] 410547 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [14] 410547 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [15] 410548 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [15] 410548 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [16] 410550 0
Anxiety disorder subtype questions (self developed)
Timepoint [16] 410550 0
Pre-intervention (Week 0), post intervention (Week 6), and 3 month follow-up (Week 18).
Secondary outcome [17] 413669 0
Digital Working Alliance Inventory
Timepoint [17] 413669 0
Post-intervention (Week 6)
Secondary outcome [18] 413670 0
User Engagement Scale - Short Form
Timepoint [18] 413670 0
Post-intervention (Week 6)
Secondary outcome [19] 413671 0
System Usability Scale
Timepoint [19] 413671 0
During Intervention (Week 3)

Eligibility
Key inclusion criteria
Participants must be 18 years or older, currently using benzodiazepines, have access to the internet, provide consent, and be able to register online using an email address.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not be residing overseas, do not have a current untreated and severe (psychotic) illness, nor will they be using the ‘cold turkey’ method to reduce their benzodiazepine intake during the study (i.e., complete withdrawal from their benzodiazepines).

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
Efficacy
Statistical methods / analysis
Pre-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Assuming a conservative small-medium effect (i.e. GPower f(v) test = 0.25), significance set at 5% (p = .05), power at 80%, a sample of 26 will be required to demonstrate statistical significance on the primary outcome measure. However allowing for a 50% attrition rate, we will be required to recruit 52 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
15/07/2023
Actual
Date of last data collection
Anticipated
21/12/2023
Actual
Sample size
Target
52
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311584 0
University
Name [1] 311584 0
Federation University
Country [1] 311584 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 313022 0
None
Name [1] 313022 0
Address [1] 313022 0
Country [1] 313022 0
Other collaborator category [1] 282368 0
Other Collaborative groups
Name [1] 282368 0
Reconnexion: A service of EACH
Address [1] 282368 0
1939 Malvern Road, Malvern East: Victoria, 3145
Country [1] 282368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311034 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 311034 0
Federation University Australia. Office 218, Building F, Mt Helen Campus.
PO Box 663, Ballarat VIC 3353
Ethics committee country [1] 311034 0
Australia
Date submitted for ethics approval [1] 311034 0
02/06/2022
Approval date [1] 311034 0
06/06/2022
Ethics approval number [1] 311034 0
A15-006

Summary
Brief summary
An open trial will be used to evaluate the effectiveness of the benzodiazepine digital health program (BDZ digital health) that provides psycho-education and gradual reduction information. BDZ digital health can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ digital health evaluation study.

BDZ digital health is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., when to complete the during, post/follow-up intervention questionnaires). During the course of the study, we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion.

Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 3) assessments, a post-intervention assessment (Week 6) and a 3-month follow-up scheduled assessment (Week 18). Participants will continue to have access to the program until Week 26 (8 weeks following the 3-month assessment). Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program.

It is expected that people who undertake BDZ digital health will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and 3-month follow-up time points.
Trial website
https://bdz.healthzone.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119762 0
Prof Britt Klein
Address 119762 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119762 0
Australia
Phone 119762 0
+61 353276717
Fax 119762 0
Email 119762 0
b.klein@federation.edu.au
Contact person for public queries
Name 119763 0
Prof Britt Klein
Address 119763 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119763 0
Australia
Phone 119763 0
+61 353276717
Fax 119763 0
Email 119763 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 119764 0
Prof Britt Klein
Address 119764 0
Federation University Australia (Churchill Campus)
Northways Road, Churchill VIC 3842
Country 119764 0
Australia
Phone 119764 0
+61 353276717
Fax 119764 0
Email 119764 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any relevant participant data collected during the trial, after non-identification.
When will data be available (start and end dates)?
Available from the time of completion of data collection with no determined end date.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the non-identified data and approval granted. The Principal Investigator can be contacted via email (b.klein@federation.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16315Informed consent form https://bdz.healthzone.org.au/plis/ 



Results publications and other study-related documents

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