Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001318774
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
11/10/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
11/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Walk-and-Talk Psychotherapy for Men with Low Mood: A Pilot Study
Scientific title
Feasibility and Preliminary Efficacy of Walk-and-Talk Psychotherapy for Australian Men with Low Mood: A Pilot Study
Secondary ID [1] 308128 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 327845 0
Condition category
Condition code
Mental Health 324922 324922 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 6x 60 minute outdoor walking psychotherapy sessions over 6 weeks (one session per week, 6 hours total contact). In the sessions, the therapist will follow a person-centered counselling approach using counselling micro-skills to address important issues identified by the participant. The sessions will take place while walking along a pre-approved route nearby the University of Newcastle's Callaghan Campus Psychology Clinic.

Therapists: The sessions will be delivered by provisional psychologists completing their practicum placement at the University of Newcastle's Psychology Clinic - Callaghan Campus. All therapists will have received training in person-centered counseling approaches during their study. To prevent confounding, therapists will be allocated clients from each study arm (but each client will have the same therapist 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 that week, where possible.

Materials: If needed, participants and therapists 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: Therapists will keep a session log documenting participant attendance (Y/N) and whether the session could be delivered as intended (i.e., walking outside).
Intervention code [1] 324586 0
Treatment: Other
Comparator / control treatment
Arm 2: Usual-Care Control

Intervention description and dose: Participants in the usual care control arm will receive 6x 60 minute indoor, seated psychotherapy sessions over 6 weeks (one session per week, 6 hours total contact). In the sessions, the therapist will follow a person-centered counselling approach using counselling micro-skills to address important issues identified by the participant.

Therapists: The sessions will be delivered by provisional psychologists completing their practicum placement at the University of Newcastle's Psychology Clinic - Callaghan Campus. All therapists will have received training in person-centered counseling approaches during their study. To prevent confounding, therapists will be allocated clients from each study arm (but each client will have the same therapist 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.

Treatment adherence and fidelity: Therapists will keep a session log documenting participant attendance (Y/N) and whether the session could be delivered as intended (i.e., seated indoors).
Control group
Active

Outcomes
Primary outcome [1] 332733 0
Outcome: Participant session attendance

Measurement tool: Session attendance log.
Completed by: Therapists.
Metric: Average proportion of sessions attended by participants.
Indicator of feasibility: At least 50% of sessions attended on average. Each study arm will be evaluated independently.
Timepoint [1] 332733 0
Post-intervention (7 weeks post baseline).
Primary outcome [2] 332734 0
Outcome: Fidelity (session location):

Measurement tool: Session log.
Completed by: Therapists.
Metric: Average proportion of sessions delivered in the intended setting (i.e., indoor vs outdoor).
Indicator of feasibility: At least 50% of sessions delivered in the intended setting. Each study arm will be evaluated independently.
Timepoint [2] 332734 0
Post-intervention (7 weeks post-baseline)
Primary outcome [3] 332735 0
Outcome: Participant satisfaction

Measurement tool: Participants overall satisfaction with therapy using a single item likert scale developed for this study (1 = Poor, 2 = Fair, 3 = Average, 4 = Good, 5 = Excellent).
Completed by: Participants.
Metric: Group mean.
Indicator of feasibility: Mean score at least 4 / 5. Each study arm will be evaluated independently.
Timepoint [3] 332735 0
Post-intervention (7 weeks post-baseline)
Secondary outcome [1] 414539 0
Outcome: Recruitment capability

Measurement tool: Study database.
Completed by: Research team.
Metric: Number of eligible participants randomised.
Indicator of feasibility: 30 participants recruited for trial.
Timepoint [1] 414539 0
Baseline
Secondary outcome [2] 414540 0
Outcome: Participant Retention

Measurement tool: Study database.
Completed by: Research team.
Metric: Number of randomised participants who complete post-intervention questionnaire.
Indicator of feasibility: At least 80% of participants retained.
Timepoint [2] 414540 0
Post-intervention (7 weeks post-baseline).
Secondary outcome [3] 414542 0
Outcome: Change in depressive symptoms.
Measure: DASS-21 Depression Subscale.
Timepoint [3] 414542 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [4] 414543 0
Outcome: Change in anxiety symptoms.
Measure: DASS-21 Anxiety Subscale.
Timepoint [4] 414543 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [5] 414544 0
Outcome: Change in stress symptoms.
Measure: DASS-21 Stress Subscale.
Timepoint [5] 414544 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [6] 414545 0
Outcome: Change in overall negative emotional state.
Measure: DASS-21 Total Score.
Timepoint [6] 414545 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [7] 414546 0
Outcome: Change in mental well-being.
Measure: Warwick-Edinburgh Mental Well-being Scale.
Timepoint [7] 414546 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [8] 414547 0
Outcome: Change in masculine depression symptoms.
Measure: Male Depression Risk Scale - 22 item.
Timepoint [8] 414547 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [9] 414548 0
Outcome: Change in experiential avoidance.
Measure: Acceptance and Action Questionnaire (AAQ-II).
Timepoint [9] 414548 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [10] 414550 0
Outcome: Change in behavioural activation score.
Measure: Behavioural Activation for Depression - Short Form (BADS-SF).
Timepoint [10] 414550 0
Baseline, and 7 weeks post-baseline.
Secondary outcome [11] 414556 0
Outcome: Mean participant session satisfaction rating.
Measure: Adapted version of the Session Rating Scale.
Timepoint [11] 414556 0
Post-intervention (7 weeks post-baseline). Participants will complete this brief measure after each session and the average score across all sessions will be compared between groups at post-intervention.
Secondary outcome [12] 414557 0
Outcome: Participant perceptions of the therapeutic alliance.
Measure: Working Alliance Inventory Short Form.
Timepoint [12] 414557 0
Post-intervention only (7 weeks post-baseline).
Secondary outcome [13] 414558 0
Outcome: Restorative impact of therapy.
Measure: Adapted Relaxation and Restoration Scale.
Timepoint [13] 414558 0
Post-intervention only (7 weeks post-baseline).

Eligibility
Key inclusion criteria
- Identify as Male;
- Aged 18-70 years;
- Experiencing mild to severe depressive symptoms for at least two weeks (Patient Health Questionnaire - 9 item [PHQ-9] score = 5 or above);
- Available to attend six therapy sessions at the University of Newcastle over 6 weeks; and
Willing to participate in their assigned treatment group for the duration of the study period.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant risk of suicide (determine after psychologist consultation for any men reporting current thoughts of suicide or self-harm in study screening);
- Currently receiving psychotherapy;
- Have started a new medication or changed medication dose in the past 4 weeks;
- Unable to speak, read or understand English;
- No access to an internet connected smart-phone, tablet or computer to complete surveys;
- Planning to move out of the area during the study period;
- Not willing to be randomly allocated into either study group; or
- Unable to walk for 1 hour.

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)
Information for the two study groups will be pre-packed into identical white, opaque envelopes. These envelopes will be consecutively numbered and ordered according to the randomisation schedule. The packing and sequencing of these envelopes will be completed by a research assistant who is not involved in the enrolment, assessment or allocation of participants.

After each participant has completed the baseline measures, an independent research assistant will make contact via phone to conduct the randomisation process, where they will open the next available envelope, inform the participant of their group assignment, and book them in for the sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised at an individual level. The allocation sequence will be generated by a member of the research team who will not be involved in enrolment, assessment, or allocation of participants using a computer-based random number-producing algorithm. Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in allocating participants to groups or those participating in data entry for the study. Complete separation will be achieved between those who generate the randomisation sequence and pack the envelopes to the research assistant who will open the envelopes and conduct the group assignment process.
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
Sample size: A sample size calculation is not required for pilots, but we will recruit 30 participants to provide stable estimates of retention, satisfaction, and preliminary efficacy. This sample also aligns with Whitehead et al's (2016) recommendation to recruit 15 participants per condition in pilot trials of future RCTs that will aim to detect a medium effect size between groups (90% power, two-sided test, p<0.05).

Analyses: Descriptive analyses will assess feasibility outcomes. Intention-to-treat linear mixed models will identify the preliminary impact on key efficacy outcomes. As the trial is not specifically powered to detect changes in efficacy-related outcomes, the interpretation of results will focus on the overall group-by-time effect size (cohen's d) rather than indicators of statistical significance.

Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016;25:1057-73. doi:10.1177/0962280215588241 pmid:26092476.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2022
Actual
Date of last participant enrolment
Anticipated
28/10/2022
Actual
Date of last data collection
Anticipated
16/12/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312385 0
University
Name [1] 312385 0
University of Newcastle, Australia
Country [1] 312385 0
Australia
Primary sponsor type
Individual
Name
Dr Myles Young
Address
W257 Behavioural Sciences
University of Newcastle
University Drive, Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 313957 0
None
Name [1] 313957 0
N/A
Address [1] 313957 0
N/A
Country [1] 313957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311742 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 311742 0
Ethics committee country [1] 311742 0
Australia
Date submitted for ethics approval [1] 311742 0
19/08/2022
Approval date [1] 311742 0
26/09/2022
Ethics approval number [1] 311742 0
H-2022-0276

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

Contacts
Principal investigator
Name 122210 0
Dr Myles Young
Address 122210 0
W257 Behavioural Sciences
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 122210 0
Australia
Phone 122210 0
+61 2 49 216 096
Fax 122210 0
Email 122210 0
myles.young@newcastle.edu.au
Contact person for public queries
Name 122211 0
Myles Young
Address 122211 0
W257 Behavioural Sciences
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 122211 0
Australia
Phone 122211 0
+61 2 49 216 096
Fax 122211 0
Email 122211 0
myles.young@newcastle.edu.au
Contact person for scientific queries
Name 122212 0
Myles Young
Address 122212 0
W257 Behavioural Sciences
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 122212 0
Australia
Phone 122212 0
+61 2 49 216 096
Fax 122212 0
Email 122212 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.