Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000794505
Ethics application status
Approved
Date submitted
23/05/2024
Date registered
27/06/2024
Date last updated
2/09/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Walk-and-talk vs indoor therapy for men with low mood: A randomised trial
Scientific title
Comparative effectiveness of walk-and-talk vs traditional psychotherapy for men with low mood: A randomised trial
Secondary ID [1] 311849 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 333379 0
Condition category
Condition code
Mental Health 330072 330072 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Walk-and-Talk Psychotherapy

Intervention description and dose: Participants in the 'walk-and-talk' arm will receive 10 x 60 minute outdoor walking psychotherapy sessions over 20 weeks (one session per fortnight, 10 hours total contact). In the sessions, the therapist will follow a non-specific supportive counselling approach using counselling micro-skills to address important issues identified by the participant (e.g., emotional concerns, relationship issues, work stressors). The sessions will take place while walking along a pre-determined route nearby the University of Newcastle's Callaghan Campus Psychology Clinic.

Psychologists: The sessions will be delivered by provisional or fully registered psychologists. To prevent confounding, Psychologists will be allocated clients from each study arm (but each client will have the same psychologist for the whole study).

Mode: Face-to-face, outdoor walking therapy.

Procedures: After booking in for their sessions at the beginning of the trial, participants will receive a text message reminder the day before each session. If they are unable to attend, they will have an opportunity to reschedule their session for an alternate time where possible.

Materials: If needed, participants and psychologists will have access to insect repellant plus ponchos and/or umbrellas for use in mild wet weather. Neither group will receive informational materials during the study.

Location: University of Newcastle, Callaghan Campus.

Treatment adherence and fidelity: Psychologists will keep a session log documenting participant attendance (Y/N), whether the session could be delivered as intended (i.e., walking outside), and whether there were any adverse events during the session (using the Unwanted Events and Adverse Treatment Reaction Checklist).
Intervention code [1] 328309 0
Treatment: Other
Comparator / control treatment
Arm 2: Usual-Care Control

Intervention description and dose: Participants in the usual care control arm will receive 10 x 60 minute indoor, seated psychotherapy sessions over 20 weeks (one session per fortnight, 10 hours total contact). In the sessions, the therapist will follow a non-specific supportive counselling approach using counselling micro-skills to address important issues identified by the participant (e.g., emotional concerns, relationship issues, work stressors). The sessions will take place indoors in a private therapy room located at the University of Newcastle's Callaghan Campus.

Psychologists: The sessions will be delivered by provisional or fully registered psychologists. To prevent confounding, psychologists will be allocated clients from each study arm (but each client will have the same psychologists for the whole study).

Mode: Face-to-face, indoor seated psychotherapy.

Procedures: After booking in for their sessions at the beginning of the trial, participants will receive a text message reminder the day before each session. If they are unable to attend, they will have an opportunity to reschedule their session for an alternate time that week, where possible.

Materials: Neither group will receive physical or informational materials during the study.

Location: University of Newcastle, Callaghan Campus, University of Newcastle.

Treatment adherence and fidelity: Psychologists will keep a session log documenting participant attendance (Y/N), whether the session could be delivered as intended (i.e., seated indoors), and whether there were any adverse events during the session (using the Unwanted Events and Adverse Treatment Reaction Checklist).
Control group
Active

Outcomes
Primary outcome [1] 337881 0
Change in overall psychological distress
Timepoint [1] 337881 0
Pre-program (baseline), post-program (5 months post baseline; primary timepoint), and follow-up (12 months post baseline)
Secondary outcome [1] 433577 0
Change in depressive symptoms
Timepoint [1] 433577 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [2] 433578 0
Change in anxiety symptoms
Timepoint [2] 433578 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [3] 433579 0
Change in stress symptoms
Timepoint [3] 433579 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [4] 433580 0
Change in male-type depression symptoms
Timepoint [4] 433580 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [5] 433581 0
Change in suicidal ideation
Timepoint [5] 433581 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [6] 433582 0
Change in mental well-being
Timepoint [6] 433582 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [7] 434148 0
Change in average steps per day
Timepoint [7] 434148 0
Pre-program (baseline), and post-program (5 months post baseline).
Secondary outcome [8] 434149 0
Change in sleep quality
Timepoint [8] 434149 0
Pre-program (baseline), and post-program (5 months post baseline).
Secondary outcome [9] 434150 0
Difference in mental restoration during therapy
Timepoint [9] 434150 0
Post-program (5 months post baseline)
Secondary outcome [10] 434151 0
Change in engagement in valued activities
Timepoint [10] 434151 0
Pre-program (baseline), and post-program (5 months post baseline).
Secondary outcome [11] 434152 0
Therapeutic Processes
Timepoint [11] 434152 0
During intervention (after sessions 1, 5, & 10)
Secondary outcome [12] 434157 0
Change in quality of life - mental domain
Timepoint [12] 434157 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [13] 434158 0
Change in quality of life - physical domain
Timepoint [13] 434158 0
Pre-program (baseline), post-program (5 months post baseline), and follow-up (12 months post baseline)
Secondary outcome [14] 436642 0
Clinically meaningful reduction in overall psychological distress
Timepoint [14] 436642 0
Post-program (5 months post baseline) and follow-up (12 months post baseline).
Secondary outcome [15] 436651 0
Nature experience
Timepoint [15] 436651 0
Pre-program (baseline), and post-program (5 months post baseline).
Secondary outcome [16] 436652 0
Nature connectedness
Timepoint [16] 436652 0
Pre-program (baseline), and post-program (5 months post baseline).
Secondary outcome [17] 436656 0
Emotional control
Timepoint [17] 436656 0
Pre-program (baseline), and post-program (5 months post baseline).

Eligibility
Key inclusion criteria
1) identify as male
2) be aged 18-70 years
3) have experienced at least mild depressive symptoms in the two weeks prior (represented by a score >= 5 on the validated 9-item Patient Health Questionnaire; PHQ-9).
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1) Started a new anti-depressant medication, or changed medication dose, in the 4 weeks prior to baseline testing
2) Started receiving therapy/counselling, or changed existing therapy/counselling arrangements, in the 4 weeks prior to baseline testing
3) Unable to speak, read, or understand English
4) Unable to walk for one hour
5) Planning to relocate during the study
6) Unwilling to be randomised
7) Not available to attend therapy in one of the available timeslots
8) Significant risk of suicide (e.g., reporting current plan), determined after psychologist consultation for any men reporting current thoughts of suicide or self-harm in screener.
9) No access to an internet connected smart-phone, tablet, or computer to complete surveys

Men who report any health concerns in a pre-exercise screener (e.g., recent heart attack or stroke) will be required to provide a medical clearance from their general practitioner to participate.

We will recruit =30% of participants from areas of low socio-economic status. Men are considered to be living in areas of low socio-economic status if their postcode is ranked in the most disadvantaged 30% of suburbs in NSW, based on the Australian Bureau of Statistics SEIFA Index of Relative Socio-economic Advantage and Disadvantage (with the remainder living in areas of middle to high socio-economic status). Within each cohort, at least 15 of the 50 participants must be living in areas of low socio-economic status (30%). Men living in areas of middle to high socio-economic status may be ineligible for the study to due to this cap.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure that each psychologist working on the trial receives no more than three walk-and-talk sessions on their typical workday (of five sessions), the randomisation process will not occur until all participants have completed baseline measures and booked in for a recurring fortnightly session time. At this point, the trial coordinator will send a blinded version of the schedule (with no participant names) to a University staff member who works at a different campus and is not affiliated with the trial. This external staff member will then generate the randomisation sequence (see below) and allocate the therapy timeslots chronologically (within strata) to either ‘walk-and-talk therapy’ or ‘indoor therapy’ according to this sequence. After doing this, the external staff member will email the completed schedule to the trial coordinator, who will inform participants about their group assignment prior to the first scheduled session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The external staff member (who is not affiliated with the trial) will generate the randomisation sequence using the online Sealed EnvelopeTM randomisation tool, a computer-based random number-producing algorithm. To ensure each psychologist receives an equal share of participants from each arm, the schedule will be stratified by psychologist. The sequence will randomise participants in a 1:1 ratio, in block lengths of four to prevent psychologists from receiving more than three walking sessions on their typical workday (of five sessions).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 56 per group at 5 months will provide 80% power to detect a between group difference (in change score) of 8 units in overall psychological distress (DASS-21, a = 0.05, SD change = 15 units). To ensure complete data from 56 men per group at 5 months, we will randomise 75 to each group at baseline (n = 150 total, 50 per cohort).

Linear mixed models will examine the primary and secondary outcomes for the impact of group, time (categorical) and the group-by-time interaction. This approach ensures outcomes for participants lost to follow-up are modelled in the analyses, consistent with an intention-to-treat approach. To adjust for potential baseline differences, age, socio-economic status, baseline physical health (SF-12 physical subscale) and baseline depression treatment (i.e., concurrent use of antidepressant medication and/or external psychotherapy) will be examined to determine whether they contribute significantly to the models. If a covariate is significant, a term will be added to the model to adjust for the effects and two-way interactions with time and treatment will also be examined. If these interactions are significant, they will also be adjusted for.

For the primary outcome, we will conduct a sensitivity analysis to explore the impact of adjusting for participants' pre-randomisation treatment expectancies (for the arm they were subsequently randomised to) on the group-by-time intervention effect.
We will also investigate whether the primary group-by-time intervention effect is moderated by the following variables: age (dichotomised at the median), baseline psychological distress (DASS-21, normal-to-mild [<41] vs moderate-to-extremely severe [41+]), baseline nature connection (CN-12 score, weak [<5] vs moderate-to-strong [5+]), baseline emotional control (CMNI-46 emotional control sub-scale, greater restraint [<2] vs lower restraint [2+]), and baseline physical activity level (IPAQ short form, inactive vs minimally active/high active).

As the analyses of secondary outcomes are intended to complement the primary outcome data and provide preliminary insights for future hypothesis testing, no multiplicity adjustments will be conducted. Given the exploratory nature of these secondary analyses, p values <0.05 will be interpreted as suggestive, rather than significant effects for secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/06/2024
Actual
28/06/2024
Date of last participant enrolment
Anticipated
28/06/2025
Actual
Date of last data collection
Anticipated
3/07/2026
Actual
Sample size
Target
150
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316192 0
Government body
Name [1] 316192 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 316192 0
Australia
Funding source category [2] 316642 0
University
Name [2] 316642 0
The University of Newcastle: In-kind support
Country [2] 316642 0
Australia
Funding source category [3] 316643 0
Charities/Societies/Foundations
Name [3] 316643 0
Hunter Medical Research Institute: In-kind support
Country [3] 316643 0
Australia
Funding source category [4] 316644 0
University
Name [4] 316644 0
The University of Melbourne: In-kind support
Country [4] 316644 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 318378 0
None
Name [1] 318378 0
Address [1] 318378 0
Country [1] 318378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315011 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315011 0
Ethics committee country [1] 315011 0
Australia
Date submitted for ethics approval [1] 315011 0
12/04/2024
Approval date [1] 315011 0
07/06/2024
Ethics approval number [1] 315011 0
H-2024-0090

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

Contacts
Principal investigator
Name 133422 0
Dr Myles Young
Address 133422 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 133422 0
Australia
Phone 133422 0
+61 2 49 216 096
Fax 133422 0
Email 133422 0
myles.young@newcastle.edu.au
Contact person for public queries
Name 133423 0
Myles Young
Address 133423 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 133423 0
Australia
Phone 133423 0
+61 2 49 216 096
Fax 133423 0
Email 133423 0
myles.young@newcastle.edu.au
Contact person for scientific queries
Name 133424 0
Myles Young
Address 133424 0
W257 Behavioural Sciences University of Newcastle University Drive Callaghan, NSW 2308
Country 133424 0
Australia
Phone 133424 0
+61 2 49 216 096
Fax 133424 0
Email 133424 0
myles.young@newcastle.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


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.