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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
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

Study type
Description of intervention(s) / exposure
Participants will be provided with ten 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. Ten 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
Comparator / control treatment
No control group
Control group

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 and week 10 will also be recorded.
2. Adherence will be measured weekly for the duration of the intervention (10 weeks).
3. Adverse events will be measured weekly. for the duration of the intervention (10 weeks).
Primary outcome [2] 325536 0
Satisfaction questionnaire (developed for this study)
Timepoint [2] 325536 0
Post intervention (week 10)
Secondary outcome [1] 388329 0
Self-reported physical activity levels (SIMPAQ)
Timepoint [1] 388329 0
During session 1 (first intervention session) and during intervention sessions 5 and 10.
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), mid way (after intervention session 5) and post (after intervention session 10)
Secondary outcome [3] 388331 0
Depression (PHQ-9)
Timepoint [3] 388331 0
Pre (prior to intervention session 1), mid way (after intervention session 5) and post (after intervention session 10)
Secondary outcome [4] 388332 0
Anxiety (GAD-7)
Timepoint [4] 388332 0
Pre (prior to intervention session 1), mid way (after intervention session 5) and post (after intervention session 10)

Key inclusion criteria
Participants will be recruited through the Black Dog Institute Depression Clinic.

Inclusion criteria
• Between 18 and 65 years
• Diagnosis of Major Depressive Disorder (with or without anxiety disorders)
• 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 OR approval from the participant’s GP).
• English speaking
• Access to the Internet and a computer at home.

Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
• Diagnosed psychotic illness e.g. schizophrenia, schizoaffective disorder
• Diagnosed bipolar disorder
• Substance abuse disorder
• Pregnancy

Study design
Purpose of the study
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
Who is / are masked / blinded?

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

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 307086 0
Name [1] 307086 0
Black Dog Institute
Address [1] 307086 0
Black Dog Institute
Hospital Rd, Randwick,
NSW, 2031
Country [1] 307086 0
Funding source category [2] 307087 0
Name [2] 307087 0
Yarranabbe Foundation
Address [2] 307087 0
Hospital Rd,
NSW, 2031
Country [2] 307087 0
Primary sponsor type
University of New South Wales
University of New South Wales
NSW, 2052
Secondary sponsor category [1] 307657 0
Name [1] 307657 0
Address [1] 307657 0
Country [1] 307657 0

Ethics approval
Ethics application status
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
University of New South Wales
NSW, 2052
Ethics committee country [1] 307204 0
Date submitted for ethics approval [1] 307204 0
Approval date [1] 307204 0
Ethics approval number [1] 307204 0

Brief summary
Physical activity is an important component of treatment for people living with Major Depressive Disorder (MDD) and is known to reduce symptoms of mental illness. There is a growing interest in the use of telehealth to improve access to health services. However, to our knowledge, there has not been research to date examining the use of telehealth by exercise physiologists to deliver physical activity interventions to adults with MDD.

We therefore aim to determine the acceptability and feasibility of a 10-week exercise physiology intervention, involving weekly sessions delivered via videoconference to adults living with MDD. We hypothesise that this intervention will be feasible and acceptable to adults with depression. In addition, we hypothesise that this 10-week physical activity intervention delivered via telehealth will be associated with improvements in symptoms of depression and anxiety, sleep quality and increased activity levels, after 5 sessions and also after 10 sessions.
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
The number of participants is very small and participants will be attending the same clinic and therefore may be identifiable.
What supporting documents are/will be available?
No other documents available
Summary results
No Results