Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000025831
Ethics application status
Approved
Date submitted
28/10/2020
Date registered
14/01/2021
Date last updated
15/02/2022
Date data sharing statement initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise physiology delivered via telehealth for adults with Major Depressive Disorder
Scientific title
Exercise physiology delivered via telehealth for adults with Major Depressive Disorder: A pilot trial to assess feasibility and acceptability
Secondary ID [1] 302652 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 319553 0
Condition category
Condition code
Mental Health 317501 317501 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with five weekly exercise physiology sessions delivered via telehealth. Telehealth calls will occur via the Microsoft office platform ‘Teams’ which has both audio and video functions. Sessions will be delivered by an accredited exercise physiologist and last between 30-40 mins. Five sessions will be delivered and occur once per week. The intervention will include evidence-based components of education, goal setting and self-monitoring. Exercise prescription will be individualised but aim to include a combination of aerobic (e.g. jogging on the spot, star jumps) and resistance exercise (e.g. push ups, squats). The exercise physiologist will demonstrate and instruct a range of exercises (e.g. sitting to stand from a chair or push ups) and have the participant do them over video call. No equipment will be required but the participant can use equipment in their home if they have it. The BORG RPE scale from which ranges from 6-20 will be used to allow participants to report how easy/hard they are finding the exercise. The intensity of the sessions will be individualised and determined by the participants baseline fitness and their preference. To obtain mental health benefits, prioritising patient enjoyment is important. The exercise physiologist will also take time to discuss different motivational strategies such as ways to overcome barriers to exercise. Participants will also be encouraged to reduce sedentary time and the exercise physiologist will help come up with strategies on ways to do this (e.g. setting an alarm every hour to remind you to get up). The exercise physiologist will provide participants with existing resources where appropriate e.g. physical activity guidelines, physical activity tracking apps etc.
Intervention code [1] 318939 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325535 0
Feasibility assessed as a composite outcome of:
1. Retention in study as assessed by completion of post program questionnaires
2. Adherence to sessions as assessed by weekly attendance records
3. Any adverse events- reported by participant and clinician during sessions and reported in session notes.
Timepoint [1] 325535 0
1. Retention will be assessed weekly throughout the study. % at the end of week 5 be recorded. 2. Adherence will be measured weekly for the duration of the intervention (5 weeks). 3. Adverse events will be measured weekly. for the duration of the intervention (5 weeks).
Primary outcome [2] 325536 0
Satisfaction questionnaire (developed for this study)
Timepoint [2] 325536 0
Post intervention (week 5)
Secondary outcome [1] 388329 0
Self-reported physical activity levels (SIMPAQ)
Timepoint [1] 388329 0
During session 1 (first intervention session) and during the final intervention sessions 5.
Secondary outcome [2] 388330 0
Sleep quality (5-item questionnaire) developed specifically for this study.
Timepoint [2] 388330 0
Pre (prior to intervention session 1) and post (after intervention session 5).
Secondary outcome [3] 388331 0
Depression (PHQ-9)
Timepoint [3] 388331 0
Pre (prior to intervention session 1) and post (after intervention session 5).
Secondary outcome [4] 388332 0
Anxiety (GAD-7)
Timepoint [4] 388332 0
Pre (prior to intervention session 1) and post (after intervention session 5).

Eligibility
Key inclusion criteria
Participants will be recruited through the Black Dog Institute website and social media.

Inclusion criteria
• Between 18 and 65 years
• Have been diagnosed with depression by a health professional (eg, GP, psychologist or psychiatrist)
• Currently experiencing symptoms of depression (indicated by a PHQ-9 score of 10 to 19)
• Have a regular general practitioner (GP)
• Currently inactive (defined as engaging in less than 150 mins per week of moderate-vigorous physical activity per week)
• Medically cleared to participate in an exercise program (as indicated by no positive scores on the Adult Pre-Exercise Screening System assessing contraindications to exercise participation).
• English speaking
• Access to the Internet and a computer at home.
• Live in Australia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Currently experiencing severe depression (PHQ-9 score of 20 or more) or suicidal thoughts (PHQ-9 item 9 score of 1 or more)
• Diagnosed psychotic illness e.g. schizophrenia, schizoaffective disorder
• Diagnosed bipolar disorder
• Substance abuse disorder
• Pregnancy

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307086 0
Charities/Societies/Foundations
Name [1] 307086 0
Black Dog Institute
Country [1] 307086 0
Australia
Funding source category [2] 307087 0
Charities/Societies/Foundations
Name [2] 307087 0
Yarranabbe Foundation
Country [2] 307087 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Kensington
NSW, 2052
Country
Australia
Secondary sponsor category [1] 307657 0
None
Name [1] 307657 0
Address [1] 307657 0
Country [1] 307657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307204 0
University of New South Wales Human Research Ethics Committee B (UNSW HREC B)
Ethics committee address [1] 307204 0
Ethics committee country [1] 307204 0
Australia
Date submitted for ethics approval [1] 307204 0
Approval date [1] 307204 0
16/10/2020
Ethics approval number [1] 307204 0

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

Contacts
Principal investigator
Name 106398 0
A/Prof Sam Harvey
Address 106398 0
Black Dog Institute,
Hospital Road
Randwick, NSW, 2031
Country 106398 0
Australia
Phone 106398 0
+61 02 9382 4517
Fax 106398 0
Email 106398 0
[email protected]
Contact person for public queries
Name 106399 0
Joanna Crawford
Address 106399 0
Black Dog Institute,
Hospital Road
Randwick, NSW, 2031
Country 106399 0
Australia
Phone 106399 0
+61 02 90659112
Fax 106399 0
Email 106399 0
[email protected]
Contact person for scientific queries
Name 106400 0
Joanna Crawford
Address 106400 0
Black Dog Institute,
Hospital Road
Randwick, NSW, 2031
Country 106400 0
Australia
Phone 106400 0
+61 02 90659112
Fax 106400 0
Email 106400 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


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.