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Trial registered on ANZCTR


Registration number
ACTRN12620000369921p
Ethics application status
Submitted, not yet approved
Date submitted
5/02/2020
Date registered
17/03/2020
Date last updated
17/03/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical activity combined with Acceptance and Commitment Therapy for individuals with Alopecia Areata: A randomised controlled trial
Scientific title
Physical activity combined with Acceptance and Commitment Therapy for individuals with Alopecia Areata: A randomised controlled trial
Secondary ID [1] 299817 0
YR03035
Universal Trial Number (UTN)
U1111-1243-5867
Trial acronym
Linked study record



Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 315194 0
Physical activity levels 315195 0
Depression 316132 0
Anxiety 316242 0
Stress 316243 0
Condition category
Condition code
Skin 313508 313508 0 0
Dermatological conditions
Mental Health 314423 314423 0 0
Depression
Mental Health 314529 314529 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the benefits on acceptance of Alopecia Areata (AA) and the impact of physical activity (PA) participation on mental health. This study will utilise Acceptance and Commitment Therapy (ACT) and PA to improve daily functioning and mental wellbeing in people with AA. The participants will be asked to complete a six-week programme consisting of ACT/PA, ACT only or PA only.

The ACT is online self-help based on ACT. Participants will have to complete a total of six sessions, once per week, with each session lasting one hour in the Qualtrics platform. The sessions will follow the psychological approach Acceptance and Commitment Therapy (ACT) and are designed to promote psychological flexibility through methods that encourage openness, awareness and engagement and will be facilitated by the online platform Qualtrics. The content of the sessions will be adapted from an ACT treatment manual used in a recently published study and available to members of the Association for Contextual Behavioural Science (ACBS) from the website http://www.contextualscience.org/better_living_with_illness.

Participants in the intervention group (PA only and ACT+PA) will receive PA recommendations by means of FitBit activity prompts, emails, phone calls, brochures, newsletter to increase PA participation to achieve their individuals PA goals twice a week. These materials are readily available resources obtained from Australian Institute of Health and Welfare (AIHW).

During the intervention, participants will be encouraged to gradually increase their activity level to at least 150 min/week of moderate-to-vigorous PA (MVPA), with the goal of walking at least 45 min per day, 6 days per week, and personal goals associated with physical activities that improve strength, resistance, balance, and flexibility. However, participants will be advised that individual physical and mental capabilities should be considered prior to performing any PA. Notification on Fitbit will be disabled and advice on PA will not be given to the control and ACT only group. Fidelity to intervention adherence was measured by periodically administered IPAQ-SF questionnaire.

ACT will be done online using the Qualtrics platform. Participants will be allocated into any one of the following groups: (1) PA only; (2) PA and ACT; (3) ACT only; and (4) Control. FitBit will be posted to participants once they agree to participate. Demographic data will be collected online. Acceptance of the condition (AA), behavioural activation and PA levels will be measured using questionnaires online.
Intervention code [1] 316761 0
Behaviour
Comparator / control treatment
The control group will not receive any intervention including ACT and PA. Notification on Fitbit will be disabled and advice on PA will not be given to the control group.
Control group
Active

Outcomes
Primary outcome [1] 322764 0
Physical Activity Levels (Fitbit Inspire)

All participants will receive a Fitbit as self-monitoring and motivational tools. Physical activity will be measured using both the Fitbit Inspire wearable activity tracker and IPAQ-SF. The trackers provide an objective indicator of physical activity behaviour and avoid common sources of error in subjective measurement (e.g., self-report measurement). The Fitbit Inspire has an internal memory that can store data for up to 30 days and data can be transferred wirelessly to the Fitbit Inspire website via a smartphone application or by computer using the dongle provided. The ease of download of information from the Fitbit Inspire website will enable the data to be captured remotely. Data collected will in terms of active minutes. Fitbit devices calculate active minutes using the metabolic equivalent of task (METs). METs help measure the energy expenditure of various activities. The participants are encouraged to wear the Fitbit, at all times to track their physical activity.
Timepoint [1] 322764 0
Week o
Week 3
Week 7
Secondary outcome [1] 379642 0
Mental Health symptoms (Depression and Anxiety Stress Scale (DASS 21) questionnaire)
Timepoint [1] 379642 0
Week 0
Week 3
Week 7
Secondary outcome [2] 381164 0
Behavioural Activation Levels (The Behavioural Activation for Depression Scale-Short Form (BADS-SF)
Timepoint [2] 381164 0
Week 0
Week 3
Week 7
Secondary outcome [3] 381165 0
Acceptance of condition Levels (Acceptance of Illness (AIS) Scale)
Timepoint [3] 381165 0
Week 0
Week 3
Week 7
Secondary outcome [4] 381166 0
Physical activity Levels (International Physical Activity Questionnaire- Short Form (IPAQ-SF)
Timepoint [4] 381166 0
Week 0
Week 3
Week 7

Eligibility
Key inclusion criteria
1. Diagnosed with Alopecia Areata by dermatologists or clinicians
2. Aged between 18 to 65 years old
3. Can communicate effectively in the English Language
4. Have daily access to electronic device or computer with Internet access
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosed with any conditions which limit their ability to participate in physical activities (e.g. chronic obstructive pulmonary disease (COPD), cardiovascular disease (CHD) or stroke.
2. Experienced unexplained pains or discomfort in your chest at rest or during physical activity/exercise.
3. Feel faint, dizzy or lose balance during physical activity/exercise.
4. Had an asthma attack requiring immediate medical attention at any time over the last 12 months.
5. Have diabetes (type 1 or 2) have you had trouble controlling your blood sugar (glucose) in the last 3 months.
6. Other conditions that may require special consideration to exercise.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will take place after baseline measures have been assessed as recommended by the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Randomisation will be coordinated by the principal researcher (YR) with guidance from the supervisory team. On receipt of consent forms and baseline measures, participants will be assigned to the intervention (PA only, ACT only and PA +ACT) or control group in a 3:1 allocation ratio using block randomisation, with a block size of 10. Sealed sequentially numbered opaque envelopes will be used to ensure concealed allocation. A computer-generated allocation sequence will be created and saved in a folder only accessible by the research team. A position of equipoise will be maintained but blinding of the participants and researchers to the treatment condition will not be possible. The principal researcher (YR) will not be blinded due to the practicalities of providing the intervention which involves posting the Fitbit Inspire activity tracker to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
From a feasibility perspective, data analysis will account for the numbers participating in the intervention and the numbers unwilling to participate, after eligibility is confirmed, with reasons for non-participation. This data will be examined and scrutinised using descriptive analysis to identify differences between participants and non-participants. Patient compliance, utilisation and satisfaction with the intervention will be assessed, as will completion rates for the intervention and the outcome measures. The acceptability of the physical outcome measures and questionnaires used in determining health resource use will also be reported. Additionally, the feasibility of the Fitbit data will be analysed. All measures will be scored according to standard practice and analysed for mean changes from baseline, using a one-way repeated measures ANOVA. For each outcome measure, change will be calculated as follow-up (at both week t3 and t7) minus baseline and presented alongside 95% CIs. Effect size will be calculated (Cohen’s d) for each outcome measure, at 0, 3 and 7 weeks, using the following formula: (mean post-test - mean baseline)/ (baseline standard deviation). Conventions of small (d?=?0.20), medium (d?=?0.50) and large (d?=?0.80) will be used. Preliminary feasibility results will inform the future randomised control trial (RCT) sample size calculation and the parameters for investigation to determine potential clinical meaningfulness.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
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] 304277 0
Charities/Societies/Foundations
Name [1] 304277 0
Australia Alopecia Areata Foundation
Address [1] 304277 0
PO Box 5029,
Frankston South VIC 3199.
Australia
Country [1] 304277 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
124 La Trobe St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 305217 0
None
Name [1] 305217 0
Address [1] 305217 0
Country [1] 305217 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304735 0
Human Research Ethics Committees RMIT University
Ethics committee address [1] 304735 0
124 La Trobe St, Melbourne VIC 3000
Ethics committee country [1] 304735 0
Australia
Date submitted for ethics approval [1] 304735 0
29/01/2020
Approval date [1] 304735 0
Ethics approval number [1] 304735 0

Summary
Brief summary
Identifying ways to support individuals with Alopecia Areata (AA) with mental health condition who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse are crucial. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting individuals to resume activities that have been avoided, but mental health practitioners have no specific training in promoting PA. We aim to evaluate an integrated PA together with Acceptance and Commitment Therapy (ACT), a self-help intervention to enhance mental health among individuals with AA. This study investigates, whether PA combined with ACT has a positive impact on study participants compared to stand-alone PA, ACT and control group, with regard to the self-reported secondary outcomes of: depression, anxiety, stress, and acceptance following treatment and at six-weeks follow up. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to individuals with AA, there is a need for further research to test its effectiveness through intervention, particularly with regards to combining ACT with PA to increase mental health status in individuals with AA. This intervention is a randomised control trial (RCT) to evaluate the effectiveness of PA and ACT for individuals with AA to improve mental health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98026 0
Dr Jason Wong
Address 98026 0
School of Education, RMIT Bundoora Campus, Plenty Road Bundoora 3083, Victoria, Australia
Country 98026 0
Australia
Phone 98026 0
+61 34197014
Fax 98026 0
Email 98026 0
jason.wong@rmit.edu.au
Contact person for public queries
Name 98027 0
Miss Yamuna Rajoo
Address 98027 0
School of Health and Biomedical Sciences, RMIT University, Bundoora Campus, 3083, Victoria, Australia
Country 98027 0
Australia
Phone 98027 0
+61451299025
Fax 98027 0
Email 98027 0
yamuna.rajoo@rmit.edu.au
Contact person for scientific queries
Name 98028 0
Miss Yamuna Rajoo
Address 98028 0
School of Health and Biomedical Sciences, RMIT University, Bundoora Campus, 3083, Victoria, Australia
Country 98028 0
Australia
Phone 98028 0
+61451299025
Fax 98028 0
Email 98028 0
yamuna.rajoo@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not available due to data confidentiality, however, overall study results will be available as a form of publication.
What supporting documents are/will be available?
No other documents available
Summary results
No Results