An open trial evaluation of the BDZ (information and reduction) digital health program for people using benzodiazepines.

• Register: ANZCTR
• Last refreshed on: 15 August 2022
• Main ID: ACTRN12617000574347
• Date of registration: 24/04/2017
• Prospective Registration: Yes
• Primary sponsor: Federation University
• 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.
• Date of first enrolment: 06/08/2017
• Target sample size: 72
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12617000574347.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Prof Britt Klein

• Name: Prof Britt Klein

Key inclusion & exclusion criteria

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.
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).

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Benzodiazepine dependency ;
Benzodiazepine dependency

Mental Health - Anxiety

Mental Health - Addiction

Intervention(s)

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 acc

Primary Outcome(s)

Self-reported benzodiazepine medication use via online questions (Type & Dose)[Pre-intervention, post intervention and 3 and 6 month follow-up]

Benzodiazepine dependency will be measured by the BDQ.[Pre-intervention (Week 0), post-intervention (Week 6), 3 month (Week 18), 6 month follow-up (Week 30) assessment.]

Secondary Outcome(s)

Depressive symptoms will be measured using the PHQ9[Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up.]

Mental wellness will be measured using the MHC-SF[Pre-intervention, post intervention and 3 and 6 month follow-up]

Quality of life will be measured by using the EQ-5D[Pre-intervention, post intervention and 3 and 6 month follow-up]

Anxiety will be measured by the GAD7[Pre-intervention, during intervention (Week 3), post intervention and 3 and 6 month follow-up]

Current use of prescribed medication(s) question (self-developed)[Pre-intervention, post and 3 and 6 month follow-up]

Emotional regulation will be measured using the DERS-B[Pre-intervention, post intervention and 3 and 6 month follow-up]

Optimism will be measured using the LOT-R[Pre-intervention, post intervention and 3 and 6 month follow-up]

Physical activity levels using single item questions (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Personality traits will be measured using the TIPI[Pre-intervention]

Psychological distress will be measured using the K10[Pre-intervention, post intervention and 3 and 6 month follow-up]

Use of mental health services questions (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Use of services for a physical health condition questions (self developed) [Pre-intervention, post and 3 and 6 month follow-up]

Affective styles will be measured using the ASQ[Pre-intervention, post intervention and 3 and 6 month follow-up]

Chronic physical illness diagnosis questions (self developed)[Pre-intervention]

Mental health condition diagnosis questions (self developed)[Pre-intervention]

Quality of Life Rating question - 6 point scale (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated.[Pre-intervention, post and 3 and 6 month follow-up]

Anxiety subtype questions (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Mental Health Rating question - 6 point scale (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Sleep will be measured using the ISI[Pre-intervention, post intervention and 3 and 6 month follow-up]

Treatment credibility will be measured using the TCS[Pre-intervention]

Treatment satisfaction, including engagement, will be measured using the TSQ[Post intervention]

Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.[Pre-intervention, post and 3 and 6 month follow-up]

Physical Health Rating question - 6 point scale (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Social Connectedness Rating question using a 5 point scale (self developed)[Pre-intervention, post and 3 and 6 month follow-up]

Secondary ID(s)

None

Source(s) of Monetary Support

Federation University

Ethics review

Status: Approved
Approval date: 07/02/2017
Contact:

Federation University Higher Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 14/06/2022
• Date Completed: 15/04/2022