Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001210763
Ethics application status
Approved
Date submitted
10/08/2022
Date registered
8/09/2022
Date last updated
8/09/2022
Date data sharing statement initially provided
8/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a multi-disciplinary lifestyle intervention (The Lift Project) for improving the mental health and emotional wellbeing of individuals with an affective mood disorder – a pilot study.
Scientific title
Effectiveness of a multi-disciplinary lifestyle intervention (The Lift Project) for improving the mental health and emotional wellbeing of individuals with an affective mood disorder – a pilot study.
Secondary ID [1] 307708 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression. 327267 0
Anxiety 327592 0
Condition category
Condition code
Mental Health 324400 324400 0 0
Depression
Mental Health 324511 324511 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this pilot study involves a 10-week lifestyle education program.

Participants will meet once per week for a 45-60 minute group session (maximum of 20 participants) that will be facilitated by a certified physiotherapist. The groups will meet face-to-face, however, there will be provision for the participants to attend via videoconferencing if circumstances prevent them from attending in person.

Each session the participants will view a 15-20 minute video presentation that explores a lifestyle behaviour and its potential impact upon mental wellbeing, followed by the opportunity for group discussion. The videos are standard videos that are used in The Lift Project, which is available at www.theliftproject.global. Each session will culminate with the participants being encouraged to engage for the next week in lifestyle “challenges” that align with the topic covered in the session. The topics covered each week, as well as the associated "challenges", are shown below:

The program covers the following topics:
1. Speaking positively - offering compliments to others and memorising an inspirational quote/text.
2. Movement - increasing step count or achieving 10,000 steps per day.
3. Immersion in nature - spend 30 minutes each day outside during the daylight hours.
4. Relationships - show care to those who are close.
5. Positive focus (gratitude) - journal "what went well" and perform a gratitude visit.
6. Healthy eating - eat more high-fibre foods (i.e. fruits and vegetables).
7. Sleep - prioritise sleep and reduce screen time at night and caffeine use.
8. Managing stress - practice 10 minutes of daily mindfulness.
9. Service - perform a random act of kindness each day.
10. Discovering meaning and purpose - explore meaningful goals.

Attendance at each session will be recorded by the facilitator. The participants will also be provided with a workbook that they will use to document their level of engagement with the weekly challenges.

There will be no control or comparison group for this pilot study. All individuals who meet the inclusion criteria and who express an interest in being involved in the study will be accepted until the sample size is achieved.

As described in the methods, the participants will complete a pre and post comprehensive questionnaire that will assess their mental health and wellbeing. In addition, in sessions 2 through 8 the participants will complete a concise mental health and wellbeing assessment.
Intervention code [1] 324183 0
Lifestyle
Intervention code [2] 324207 0
Treatment: Other
Comparator / control treatment
This pilot study is a pre-post study design with no comparison/control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332265 0
Depression, Anxiety and Stress Scale (DASS-21) score.
Timepoint [1] 332265 0
10 weeks (i.e. post-intervention).
Primary outcome [2] 332484 0
Mental Health and Vitality sub scales of the SF-36 instrument, which will be aggregated into a composite outcome measure.
Timepoint [2] 332484 0
Weekly (i.e. weeks 1 to 10 of the intervention)
Primary outcome [3] 332485 0
WHO Life Satisfaction score.
Timepoint [3] 332485 0
10 weeks (i.e. post-intervention).
Secondary outcome [1] 413703 0
Program engagement, measured by attendance at weekly group sessions.
Timepoint [1] 413703 0
Weekly (i.e. weeks 1 to 10 of the intervention)
Secondary outcome [2] 413747 0
Program engagement, measured by engagement with weekly "challenges", using a point system that has been designed specifically for this study.
Timepoint [2] 413747 0
Weekly (i.e. weeks 1 to 10 of the intervention).

Eligibility
Key inclusion criteria
1. People currently living with a diagnosis of an affective mood disorder (depression and/or anxiety).

2. People currently taking anti-depression and/or anti-anxiety medication.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or lactating mothers.
2. People scheduled to be taken off their respective anti-depression or anti-anxiety medication during the period of the study.

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
Paired t-tests will be used to determine changes in the outcome measures from pre to post intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/08/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
20/12/2022
Actual
Sample size
Target
30
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 24943 0
South Africa
State/province [1] 24943 0

Funding & Sponsors
Funding source category [1] 311982 0
University
Name [1] 311982 0
Avondale Universtiy
Country [1] 311982 0
Australia
Primary sponsor type
University
Name
Avondale Universtiy
Address
582 Freemans Drive, Cooranbong NSW 2265, Australia
Country
Australia
Secondary sponsor category [1] 313465 0
None
Name [1] 313465 0
Address [1] 313465 0
Country [1] 313465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311404 0
Avondale University Ethics Committee
Ethics committee address [1] 311404 0
Ethics committee country [1] 311404 0
Australia
Date submitted for ethics approval [1] 311404 0
10/06/2022
Approval date [1] 311404 0
03/08/2022
Ethics approval number [1] 311404 0
ETH.2022.009

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

Contacts
Principal investigator
Name 120978 0
Prof Darren Morton
Address 120978 0
Avondale University,
582 Freemans Drive, Cooranbong, NSW 2265
Country 120978 0
Australia
Phone 120978 0
+61 412287138
Fax 120978 0
Email 120978 0
[email protected]
Contact person for public queries
Name 120979 0
Darren Morton
Address 120979 0
Avondale University,
582 Freemans Drive, Cooranbong, NSW 2265
Country 120979 0
Australia
Phone 120979 0
+61 412287138
Fax 120979 0
Email 120979 0
[email protected]
Contact person for scientific queries
Name 120980 0
Darren Morton
Address 120980 0
Avondale University,
582 Freemans Drive, Cooranbong, NSW 2265
Country 120980 0
Australia
Phone 120980 0
+61 412287138
Fax 120980 0
Email 120980 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16881Study protocol  [email protected] 384480-(Uploaded-10-08-2022-14-52-58)-Study-related document.docx
16883Informed consent form  [email protected]
16884Ethical approval  [email protected]



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.