Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000479505
Ethics application status
Approved
Date submitted
30/04/2015
Date registered
14/05/2015
Date last updated
27/06/2022
Date data sharing statement initially provided
27/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A open trial evaluation of the Benzodiazepine (information and reduction) eHealth program (BDZ eHealth) for people using benzodiazepines.
Scientific title
A open trial evaluation of the BDZ (information and reduction) eHealth program to reduce benzodiazepine usage and decrease negative affect for Australian adults using benzodiazepines.
Secondary ID [1] 286211 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benzodiazepine dependency 294925 0
Condition category
Condition code
Mental Health 295175 295175 0 0
Addiction
Mental Health 295176 295176 0 0
Anxiety
Mental Health 295177 295177 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A simple open trial will be used to evaluate the effectiveness of the Benzodiazepine eHealth program (BDZ eHealth) that provides psycho-education and gradual reduction information. BDZ eHealth is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module.

The BDZ eHealth has five 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 program modules at their own pace, over the 5 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 post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress and activities. Modules make use of text, graphics, audio, video, editable forms 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 eHealth program, as well as work in conjunction with their doctor should they wish to commence benzodiazepine reduction.


Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1 - 5) assessments, a post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18 respectively). Participants will continue to have access to the program for the entire duration of the trial. Participants will also be asked to complete a short online questionnaire to determine the reasons for their engagement/disengagement with the program.
Intervention code [1] 291742 0
Behaviour
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294934 0
Benzodiazepine dependency will be measured by the BDQ.
Timepoint [1] 294934 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Primary outcome [2] 294935 0
Anxiety will be measured by the GAD7
Timepoint [2] 294935 0
Pre-intervention, during intervention (Week 3), post intervention and 1 and 3 month follow-up
Primary outcome [3] 294936 0
Depressive symptoms will be measured using the PHQ-9
Timepoint [3] 294936 0
Pre-intervention, during intervention (Week 3), post intervention and 1 and 3 month follow-up
Secondary outcome [1] 314386 0
General psychological distress will be measured using the Kessler 6
Timepoint [1] 314386 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [2] 314387 0
Emotional regulation will be measured using the DERS
Timepoint [2] 314387 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [3] 314388 0
Mental wellness will be measured using the MHC-SF
Timepoint [3] 314388 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [4] 314389 0
Optimism will be measured using the LOT-R
Timepoint [4] 314389 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [5] 314390 0
Sleep will be measured using the PSQI
Timepoint [5] 314390 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [6] 314391 0
Quality of life will be measured by using the EQ-5D
Timepoint [6] 314391 0
Pre-intervention, post intervention and 1 and 3 month follow-up
Secondary outcome [7] 314392 0
Treatment credibility will be measured using the TCS
Timepoint [7] 314392 0
Pre-intervention
Secondary outcome [8] 314393 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [8] 314393 0
Post intervention
Secondary outcome [9] 314394 0
Demographic and lifestyle/personal questions using a self developed measure (e.g., gender, age, exercise patterns, other drug and alcohol use)
Timepoint [9] 314394 0
Pre-intervention, post intervention and 1 and 3 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 eHealth website where they will be taken to the Plain Language Information Statement and must provide informed consent to proceed and asked five screening questions in relation to study criteria (e.g., are you currently taking benzodiazepines?). Following account creation, participants are asked to complete the pre-intervention online questionnaires. Once completed the participant is provided access to the BDZ eHealth program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
1. Pre-, post- and follow-up variables will be subjected to within group repeated measures ANOVA and MANOVA to determine significant changes over time.
2. Correlational and multiple regression analyses will be used to determine any potential predictors and discriminators of attrition and adherence.
3. Open ended data obtained from intervention satisfaction may be analysed using protocols of content analysis to identify common themes.

We have conservatively applied a small-medium effect size. Therefore, assuming a small-medium effect (i.e. GPower f test = 0.25), significance set at 5% (p = .05) and power at 80%, a total sample size of 63 (this figure also accounts for an expected attrition rate of 30%) will be required to demonstrate statistical significance on the primary outcome measure.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Release of a newer digital health platform and BDZ digital health program.
Date of first participant enrolment
Anticipated
6/07/2015
Actual
4/09/2015
Date of last participant enrolment
Anticipated
13/03/2017
Actual
9/06/2017
Date of last data collection
Anticipated
Actual
8/09/2017
Sample size
Target
63
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291181 0
University
Name [1] 291181 0
Federation University
Country [1] 291181 0
Australia
Primary sponsor type
University
Name
Federation Unversity
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 289861 0
Other Collaborative groups
Name [1] 289861 0
Reconnexion (a service of EACH)
Address [1] 289861 0
1939 Malvern Road, Malvern East: Victoria, 3145
Country [1] 289861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292753 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 292753 0
Ethics committee country [1] 292753 0
Australia
Date submitted for ethics approval [1] 292753 0
Approval date [1] 292753 0
13/02/2015
Ethics approval number [1] 292753 0
A15-006

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

Contacts
Principal investigator
Name 55090 0
Prof Britt Klein
Address 55090 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55090 0
Australia
Phone 55090 0
+61 3 53276717
Fax 55090 0
Email 55090 0
[email protected]
Contact person for public queries
Name 55091 0
Britt Klein
Address 55091 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55091 0
Australia
Phone 55091 0
+61 3 5327 6717
Fax 55091 0
Email 55091 0
[email protected]
Contact person for scientific queries
Name 55092 0
Britt Klein
Address 55092 0
Federation University University Drive, Mt Helen Campus, 3350, Victoria
Country 55092 0
Australia
Phone 55092 0
+61 3 53276717
Fax 55092 0
Email 55092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.