ANZCTR - Registration

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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

Date results information initially provided

14/06/2022

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]

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

Condition category

Condition code

Mental Health

Addiction

Mental Health

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

Treatment: Other

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Benzodiazepine dependency will be measured by the BDQ.

Timepoint [1]

Pre-intervention (Week 0), post-intervention (Week 6), 3 month (Week 18), 6 month follow-up (Week 30) assessment.

Primary outcome [2]

Self-reported benzodiazepine medication use via online questions (Type & Dose)

Timepoint [2]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [1]

Anxiety will be measured by the GAD7

Timepoint [1]

Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up

Secondary outcome [2]

Depressive symptoms will be measured using the PHQ9

Timepoint [2]

Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up.

Secondary outcome [3]

Psychological distress will be measured using the K10

Timepoint [3]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [4]

Emotional regulation will be measured using the DERS-B

Timepoint [4]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [5]

Mental wellness will be measured using the MHC-SF

Timepoint [5]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [6]

Optimism will be measured using the LOT-R

Timepoint [6]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [7]

Sleep will be measured using the ISI

Timepoint [7]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [8]

Quality of life will be measured by using the EQ-5D

Timepoint [8]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [9]

Affective styles will be measured using the ASQ

Timepoint [9]

Pre-intervention, post intervention and 3 and 6 month follow-up

Secondary outcome [10]

Treatment credibility will be measured using the TCS

Timepoint [10]

Pre-intervention

Secondary outcome [11]

Personality traits will be measured using the TIPI

Timepoint [11]

Pre-intervention

Secondary outcome [12]

Treatment satisfaction, including engagement, will be measured using the TSQ

Timepoint [12]

Post intervention

Secondary outcome [13]

Physical activity levels using single item questions (self developed)

Timepoint [13]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [14]

Social Connectedness Rating question using a 5 point scale (self developed)

Timepoint [14]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [15]

Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated.

Timepoint [15]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [16]

Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.

Timepoint [16]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [17]

Chronic physical illness diagnosis questions (self developed)

Timepoint [17]

Pre-intervention

Secondary outcome [18]

Mental health condition diagnosis questions (self developed)

Timepoint [18]

Pre-intervention

Secondary outcome [19]

Current use of prescribed medication(s) question (self-developed)

Timepoint [19]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [20]

Use of services for a physical health condition questions (self developed)

Timepoint [20]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [21]

Use of mental health services questions (self developed)

Timepoint [21]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [22]

Quality of Life Rating question - 6 point scale (self developed)

Timepoint [22]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [23]

Mental Health Rating question - 6 point scale (self developed)

Timepoint [23]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [24]

Physical Health Rating question - 6 point scale (self developed)

Timepoint [24]

Pre-intervention, post and 3 and 6 month follow-up

Secondary outcome [25]

Anxiety subtype questions (self developed)

Timepoint [25]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Federation University

Address [1]

University Drive, Mt Helen Campus, Victoria, 3350

Country [1]

Australia

Primary sponsor type

University

Name

Federation University

Address

University Drive, Mt Helen Campus, Victoria, 3350

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Reconnexion (A service of EACH)

Address [1]

1939 Malvern Road, Malvern East: Victoria, 3145

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Federation University Higher Research Ethics Committee

Ethics committee address [1]

Federation University Australia. Office 218, Building F, Mt Helen Campus.
PO Box 663, Ballarat VIC 3353

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/02/2017

Approval date [1]

07/02/2017

Ethics approval number [1]

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

Prof Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria.

Country

Australia

Phone

+61 3 5327 6717

Fax

[email protected]

Contact person for public queries

Name

Prof Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria.

Country

Australia

Phone

+61 3 5327 6717

Fax

[email protected]

Contact person for scientific queries

Name

Prof Britt Klein

Address

Federation University
University Drive, Mt Helen Campus, 3350, Victoria.

Country

Australia

Phone

+61 3 5327 6717

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
1091	Informed consent form				https://bdz.mydigitalhealth.org.au/plain-language-... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically