Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000506392
Ethics application status
Approved
Date submitted
3/04/2017
Date registered
7/04/2017
Date last updated
17/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping farmers to better cope with things beyond their control
Scientific title
Preparing Australian farmers for future challenges via an on online, interactive, acceptance and commitment therapy (ACT)-based intervention
Secondary ID [1] 291402 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 302485 0
Distress 302540 0
Wellbeing 302635 0
Condition category
Condition code
Mental Health 302045 302045 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will test whether a low cost, self-help intervention based on Acceptance and Commitment Therapy (ACT), is perceived as acceptable and helpful by Australian farmers, improves their wellbeing, and leads to effective coping when faced with future challenges. The intervention was developed in close collaboration with Australian farmers and a range of organisations from across the academic, agricultural, health and financial sectors. It has a particular focus on teaching farmers skills to cope more effectively with things beyond their control (e.g. droughts, fluctuating markets, disease outbreaks, government regulations). The program is being developed in the Sansom Institute for Health Research at the University of South Australia in collaboration with the University of Adelaide, the National Centre for Farmer Health, the Freemasons Foundation Centre for Men's Health, Livestock SA and the Freemasons Foundation.

MATERIALS

The intervention was developed based on ACT by a clinical psychologist with consumer input. All content has been reviewed by an independent clinical psychologist and a social worker with knowledge of rural and drought-related issues.

The intervention website contains five ACT-based modules that include strategies to foster the key ACT processes of defusion, acceptance, values, here and now and psychological flexibility. Users will create a profile (using a pseudonym if preferred) upon first logon. The content starts off with a quiz and practical psychoeducation information sheets. Users are then given carefully tailored feedback and advice, based on their results. Users are given the option of printing off the results of their online assessment and a script that will guide a conversation about their mental health with their GP. Users will also be presented with a short video that will show someone else having that conversation with their GP.

Users are able to log on at any time of the day or night. The intervention is a free, password protected resource written for a low reading age, in a friendly way with appropriate humor and farming related metaphors and examples, and fits with farmers’ ethos of stoicism and determination to help themselves.

Features include automated text message reminders and messages of support, and a very simple website navigation design suitable for use on desktop, laptops, iPads/tablets and mobile devices. At the end of each module, the program will put together a list of strategies that users can choose to save to their profile or 'toolbox'.

PROCEDURES

People who are interested in participating will access the website and will then be presented with an online information sheet and a consent form including screening questionnaire. Consenting participants will then proceed to a page to set up a profile/login, then move on to a suite of validated measures (see 'Outcomes') online and proceed to the online intervention.

As detailed above, the first stage of the intervention will provide participants with feedback on their current levels of well­-being and inform them if their scores suggest that they should seek professional face-to-face mental health help. More specifically, based on their distress score, they will be advised whether they are experiencing what is considered a low, medium, or high level of distress. They will also be given information on how to seek professional help and be reminded about how to return to their online intervention profile at any time. Participants will be contacted by a suitably qualified member of the research team (clinical psychologist) via phone if their results show that they are highly distressed. All participants will then work through the intervention modules, which are designed to be transdiagnostic (useful for people experiencing a range of problems/conditions and for people who simply want to improve their wellbeing).

At the completion of the five modules, participants will be asked to complete the outcome measures. After 6 months, participants will be emailed a reminder and asked to log in and complete the measures again. Once participants have completed all study-related procedures, they will be eligible for a $100 voucher as partial reimbursement for their time and internet expenses. Participants who choose to complete optional additional measures, comprising 34 items, at each of the three time points (baseline, after the completion of the five modules, and after 6 months) will be eligible for an additional $20 voucher as partial reimbursement of the additional time taken. Approximately 20 participants will also be invited to participate in an interview about their participation in the program. Some participants who indicated willingness to be followed up may also be contacted at a later date (e.g. a period of drought) and asked to re­-complete the measures online. Website usage, usability, and acceptability will also be evaluated through website usage data and additional measures.

DELIVERY

The intervention is delivered online to individuals. Participants complete five modules approximately fortnightly for five weeks, and each module is expected to take approximately 30-40 minutes to complete. Participants can access the intervention anywhere with an internet connection (e.g. laptop, desktop, tablet, mobile). Adherence will be assessed with website usage statistics.

Individual-tailored content is embedded within the website. Tailored content is delivered throughout the intervention based on participant responses and demographic variables. For example, in doing the baseline assessment, a user may flag that they are having trouble sleeping so they will be provided with a list of practical things to try to improve the quality of their sleep (e.g. sleep hygiene techniques).
Intervention code [1] 297498 0
Behaviour
Intervention code [2] 297544 0
Prevention
Intervention code [3] 297707 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301634 0
Change in psychological flexibility, measured using the Acceptance and Action Questionnaire-II (Bond et al., 2011).
Timepoint [1] 301634 0
Pre-intervention: Immediately following registration.
Post-intervention: Upon completion of the main content.
Follow-up: Six months following completion of the content.
Secondary outcome [1] 332889 0
Change in positive mental health, measured using the Mental Health Continuum - Short Form (MHC-SF; Lamers et al., 2011).
Timepoint [1] 332889 0
Pre-intervention: Immediately following registration.
Post-intervention: Upon completion of the main content.
Follow-up: Six months following completion of the content.
Secondary outcome [2] 332892 0
Change in distress scores. Distress will be measured using the Kessler Psychological Distress Scale (K10; Kessler et al., 2003).
Timepoint [2] 332892 0
Pre-intervention: Immediately following registration.
Post-intervention: Upon completion of the main content.
Follow-up: Six months following completion of the content.
Secondary outcome [3] 333426 0
Change in thought defusion, measured using the Cognitive Fusion Questionnaire (Gillanders et al., 2014).
Timepoint [3] 333426 0
Pre-intervention: Immediately following registration (optional for participants).
Post-intervention: Upon completion of the main content (optional for participants).
Follow-up: Six months following completion of the content (optional for participants).
Secondary outcome [4] 342088 0
Change in valued living, measured using the Valuing Questionnaire (Smout et al., 2014).
Timepoint [4] 342088 0
Pre-intervention: Immediately following registration (optional for participants). Post-intervention: Upon completion of the main content (optional for participants). Follow-up: Six months following completion of the content (optional for participants).
Secondary outcome [5] 342089 0
Change in mindfulness, measured using the The Five Facet Mindfulness Questionnaire – Short Form (FFMQ-SF; Bohlmeijer, Klooster & Fledderus, 2011).
Timepoint [5] 342089 0
Pre-intervention: Immediately following registration (optional for participants). Post-intervention: Upon completion of the main content (optional for participants). Follow-up: Six months following completion of the content (optional for participants).
Secondary outcome [6] 342090 0
Change in strength of automatic thoughts, measured using the The Automatic Thoughts Questionnaire (ATQ-B; Addis & Jacobson, 1996).
Timepoint [6] 342090 0
Pre-intervention: Immediately following registration. Post-intervention: Upon completion of the main content. Follow-up: Six months following completion of the content.
Secondary outcome [7] 342091 0
Change in coping strategies, measured using the acceptance subscales of the COPE Inventory (Carver et al., 1989; Carver 1997).
Timepoint [7] 342091 0
Pre-intervention: Immediately following registration. Post-intervention: Upon completion of the main content. Follow-up: Six months following completion of the content.
Secondary outcome [8] 342092 0
Change in alcohol use, measured using the Alcohol Use Disorders Identification Test (AUDIT; World Health Organisation, 2001).
Timepoint [8] 342092 0
Pre-intervention: Immediately following registration (optional for participants). Post-intervention: Upon completion of the main content (optional for participants). Follow-up: Six months following completion of the content (optional for participants).
Secondary outcome [9] 342093 0
Satisfaction with the intervention, measured using the adapted Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).
Timepoint [9] 342093 0
Post-intervention: Upon completion of the main content. Follow-up: Six months following completion of the content.
Secondary outcome [10] 342094 0
Usability and acceptability of the intervention, measured using the System Usability Scale (SUS; Tullis and Albert, 2008).
Timepoint [10] 342094 0
Post-intervention: Upon completion of the main content. Follow-up: Six months following completion of the content.

Eligibility
Key inclusion criteria
Adults who currently own or play an active role in the operation of a farming or pastoral enterprise in Australia (or the spouse of someone who does); fluent in English; has access to the internet; has access to a mobile phone with reception at least once per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment.

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
In our pilot cross-sectional cohort, the mean distress score was 9 (SD = 7, range 0­-35). Being a feasibility study we prioritise the reduction in type II errors over type I. Assuming a within individual correlation >0.5, then with N = 50 a one sample t­-test (1-­sided alpha = 0.10) has 90% power to detect a within individual change in distress of 2.5 units. Assuming a 80% retention rate, we plan to accrue 60 individuals.

Associations with outcomes will be assessed using multiple linear regressions adjusting for baseline assessments of the outcome measure, demographic factors and socioeconomic factors. Trajectories of module-satisfaction assessed repeatedly over the intervention will be modelled using mixed effects regression. These trajectories along with baseline covariates will be employed to impute missing data using multiple imputation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
1/02/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295876 0
Charities/Societies/Foundations
Name [1] 295876 0
NAB Foundation
Country [1] 295876 0
Australia
Funding source category [2] 295957 0
University
Name [2] 295957 0
Sansom Institute for Health Research, University of South Australia
Country [2] 295957 0
Australia
Funding source category [3] 295958 0
Charities/Societies/Foundations
Name [3] 295958 0
The Freemasons Foundation Inc.
Country [3] 295958 0
Australia
Funding source category [4] 295959 0
Other Collaborative groups
Name [4] 295959 0
Freemasons Foundation Centre for Men's Health
Country [4] 295959 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 294844 0
None
Name [1] 294844 0
Address [1] 294844 0
Country [1] 294844 0
Other collaborator category [1] 279480 0
University
Name [1] 279480 0
University of Adelaide
Address [1] 279480 0
North Terrace Campus
The University of Adelaide SA 5005
Country [1] 279480 0
Australia
Other collaborator category [2] 279481 0
University
Name [2] 279481 0
Deakin University/National Centre for Farmer Health
Address [2] 279481 0
1 Gheringhap Street
Geelong VIC 3220
Country [2] 279481 0
Australia
Other collaborator category [3] 279897 0
Charities/Societies/Foundations
Name [3] 279897 0
Livestock SA
Address [3] 279897 0
Unit 5 780 South Road Glandore SA 5037
Country [3] 279897 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297155 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 297155 0
Ethics committee country [1] 297155 0
Australia
Date submitted for ethics approval [1] 297155 0
05/07/2016
Approval date [1] 297155 0
23/09/2016
Ethics approval number [1] 297155 0
0000035637

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

Contacts
Principal investigator
Name 73162 0
Dr Kate Fennell
Address 73162 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 73162 0
Australia
Phone 73162 0
+61 8 8302 2137
Fax 73162 0
Email 73162 0
[email protected]
Contact person for public queries
Name 73163 0
Kate Fennell
Address 73163 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 73163 0
Australia
Phone 73163 0
+61 8 8302 2137
Fax 73163 0
Email 73163 0
[email protected]
Contact person for scientific queries
Name 73164 0
Kate Fennell
Address 73164 0
University of South Australia
City East Campus
GPO Box 2471
Adelaide SA 5001
Country 73164 0
Australia
Phone 73164 0
+61 8 8302 2137
Fax 73164 0
Email 73164 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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