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Trial registered on ANZCTR


Registration number
ACTRN12617000574347
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
1/08/2022
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An open trial evaluation of the BDZ (information and reduction) digital health program for people using benzodiazepines.
Scientific title
A pre-, post-intervention and 3- and 6-month follow up open trial evaluation of the BDZ digital health program, offered through the My Digital Health platform, to assist in reducing benzodiazepine usage and anxiety and depressive symptoms for Australian adults using benzodiazepines.
Secondary ID [1] 291132 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Ethics approval was obtained via two amendment requests (one approved on the 27/07/2016 and a subsequent one approved on the 07/02/2017) based on the originally approved A15-006 application (ACTRN12615000479505) in 2015.

Health condition
Health condition(s) or problem(s) studied:
Benzodiazepine dependency 301959 0
Condition category
Condition code
Mental Health 301610 301610 0 0
Addiction
Mental Health 301611 301611 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open trial (pre-intervention through to a 6-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 is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module.

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. The 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. A Gradual Reduction Program (Case Illustration). This third module provides an illustrative case example of ‘Peter’ outlining his gradual benzodiazepine reduction program 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, mindfulness meditation, problem solving, goal setting, increasing physical exercise, nutrition, sleep hygiene).

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 automated emails (e.g., to log on, when to complete the ‘during’, post intervention and follow-up scheduled assessment questionnaires). Modules make use of text, graphics, audio, video, editable forms, interactive games and downloads. 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 ‘My Digital Health’ dashboard. My Digital Health 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, My Profile and My Tutorial. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account.

Participants will complete a pre-intervention assessment (Week 0), ‘during’ intervention (Week 3) assessment, a post-intervention assessment (Week 6) and a 3 and 6-month follow-up assessment (Week 18 & Week 30 respectively). 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 38 (8 weeks past the 6-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 event survey and scheduled intervention assessments. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.
Intervention code [1] 297112 0
Behaviour
Intervention code [2] 297269 0
Prevention
Intervention code [3] 297796 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301010 0
Benzodiazepine dependency will be measured by the BDQ.
Timepoint [1] 301010 0
Pre-intervention (Week 0), post-intervention (Week 6), 3 month (Week 18), 6 month follow-up (Week 30) assessment.
Primary outcome [2] 332169 0
Self-reported benzodiazepine medication use via online questions (Type & Dose)
Timepoint [2] 332169 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [1] 331442 0
Anxiety will be measured by the GAD7
Timepoint [1] 331442 0
Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up
Secondary outcome [2] 331443 0
Depressive symptoms will be measured using the PHQ9
Timepoint [2] 331443 0
Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up.
Secondary outcome [3] 331444 0
Psychological distress will be measured using the K10
Timepoint [3] 331444 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [4] 331445 0
Emotional regulation will be measured using the DERS-B
Timepoint [4] 331445 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [5] 331446 0
Mental wellness will be measured using the MHC-SF
Timepoint [5] 331446 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [6] 331447 0
Optimism will be measured using the LOT-R
Timepoint [6] 331447 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [7] 331448 0
Sleep will be measured using the ISI
Timepoint [7] 331448 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [8] 331449 0
Quality of life will be measured by using the EQ-5D
Timepoint [8] 331449 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [9] 331450 0
Affective styles will be measured using the ASQ
Timepoint [9] 331450 0
Pre-intervention, post intervention and 3 and 6 month follow-up
Secondary outcome [10] 331451 0
Treatment credibility will be measured using the TCS
Timepoint [10] 331451 0
Pre-intervention
Secondary outcome [11] 331452 0
Personality traits will be measured using the TIPI
Timepoint [11] 331452 0
Pre-intervention
Secondary outcome [12] 331453 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [12] 331453 0
Post intervention
Secondary outcome [13] 331454 0
Physical activity levels using single item questions (self developed)
Timepoint [13] 331454 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [14] 334108 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [14] 334108 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [15] 334109 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated.
Timepoint [15] 334109 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [16] 334110 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [16] 334110 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [17] 334111 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [17] 334111 0
Pre-intervention
Secondary outcome [18] 334112 0
Mental health condition diagnosis questions (self developed)
Timepoint [18] 334112 0
Pre-intervention
Secondary outcome [19] 334113 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [19] 334113 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [20] 334114 0
Use of services for a physical health condition questions (self developed)
Timepoint [20] 334114 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [21] 334115 0
Use of mental health services questions (self developed)
Timepoint [21] 334115 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [22] 334116 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [22] 334116 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [23] 334117 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [23] 334117 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [24] 334118 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [24] 334118 0
Pre-intervention, post and 3 and 6 month follow-up
Secondary outcome [25] 334119 0
Anxiety subtype questions (self developed)
Timepoint [25] 334119 0
Pre-intervention, post and 3 and 6 month follow-up

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
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to register for the study on the BDZ digital health child website (or via the parent website - My Digital Health) following ‘My Digital Health’ account creation. Once an account is created, they will be required to provide their informed consent after reading through the BDZ digital health study Plain Language Information Statement. Following informed consent, participants will then be presented with the pre-intervention questionnaires. Once completed, the participant is provided access to the BDZ digital health program immediately.
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.

As there are no published studies, we will conservatively apply a small effect size. Therefore, assuming a small effect (i.e. GPower f(v) test = 0.20), significance set at 5% (p = .05), power at 80%, a sample of 36 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 72 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We have closed this trial as we are retiring the My Digital Health platform and shifting to a new upgraded platform.
Date of first participant enrolment
Anticipated
15/05/2017
Actual
6/08/2017
Date of last participant enrolment
Anticipated
31/12/2020
Actual
30/09/2021
Date of last data collection
Anticipated
30/09/2021
Actual
15/04/2022
Sample size
Target
72
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295570 0
University
Name [1] 295570 0
Federation University
Country [1] 295570 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 294396 0
None
Name [1] 294396 0
Address [1] 294396 0
Country [1] 294396 0
Other collaborator category [1] 279420 0
Other Collaborative groups
Name [1] 279420 0
Reconnexion (A service of EACH)
Address [1] 279420 0
1939 Malvern Road, Malvern East: Victoria, 3145
Country [1] 279420 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296890 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296890 0
Federation University Australia. Office 218, Building F, Mt Helen Campus.
PO Box 663, Ballarat VIC 3353
Ethics committee country [1] 296890 0
Australia
Date submitted for ethics approval [1] 296890 0
03/02/2017
Approval date [1] 296890 0
07/02/2017
Ethics approval number [1] 296890 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 and 6 month follow-up scheduled assessment (Week 18 & Week 30 respectively). Participants will continue to have access to the program until Week 38 (8 weeks following the 6 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 and 6 month follow-up time points.
Trial website
https://bdz.mydigitalhealth.org.au (direct 'child' site)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72346 0
Prof Britt Klein
Address 72346 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria.
Country 72346 0
Australia
Phone 72346 0
+61 3 5327 6717
Fax 72346 0
Email 72346 0
[email protected]
Contact person for public queries
Name 72347 0
Britt Klein
Address 72347 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria.
Country 72347 0
Australia
Phone 72347 0
+61 3 5327 6717
Fax 72347 0
Email 72347 0
[email protected]
Contact person for scientific queries
Name 72348 0
Britt Klein
Address 72348 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria.
Country 72348 0
Australia
Phone 72348 0
+61 3 5327 6717
Fax 72348 0
Email 72348 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?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
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 de-identified data and approval granted.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1091Informed consent form    https://bdz.mydigitalhealth.org.au/plain-language-... [More Details]



Results publications and other study-related documents

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