Back-on-Track: Protocol for Randomised Controlled Feasibility Trial of Behavioural Activation in Farmers with Mood Problems

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The authors present a detailed protocol for a feasibility randomized controlled trial aimed at assessing the delivery of peer-led behavioural activation therapy to members of farming communities experiencing depression. The study is co-designed with community input and includes a comparison to a control group receiving a self-help workbook (“Managing Stress on the Farm”). The feasibility outcomes include recruitment/retention, fidelity, acceptability, and completion of outcome measures.
Drawbacks:
1. Although the study is framed as a feasibility trial, the choice of secondary outcome measures and their timing suggests a potential interest in assessing effects. This should be de-emphasized or discussed cautiously.
2. The control condition is a passive intervention with minimal interaction. While acceptable for feasibility testing, the lack of attention control may lead to overestimating acceptability and engagement in the experimental arm.
3. The design is single-blinded (researcher-blinded), but participants know their allocation. The risk of performance and response bias is significant. This is acknowledged but under-discussed in terms of implications for data interpretation.
4. The total training load (~76 hours) may reduce scalability and make replication challenging in less-resourced settings. Streamlining or modularizing training should be considered.
5. Recruiting 40 eligible participants out of 120–360 contacts (based on past data) may be difficult, especially with strict exclusion criteria (e.g., recent medication start). No contingency plan is described if recruitment targets are missed.
6. While conflict of interest procedures are included, more detail on how peer-worker–participant compatibility will be optimized (e.g., gender, age, farm type) is needed for real-world deployment.
7. While an economic evaluation is planned, the specific cost components and outcome measures for economic analysis are not well-articulated.
8. The formatting of outcome measure tables could be clearer (some values are misaligned or repeated).
9. The manuscript is occasionally repetitive (e.g., describing PHQ-9 screening multiple times). 
Recommendations:
1. Clarify that the secondary outcomes are not powered for effect size estimation. Explicitly note this in the limitations section.
2. To reduce attention bias, consider adding minimal contact (e.g., check-ins) in the control group for full-scale trials.
3. Explore and discuss whether elements of the training (e.g., asynchronous modules, micro-credentials) can be adapted for future scalability.
4. Add a fallback recruitment strategy (e.g., expanding geography or relaxing minor exclusion criteria).
5. Provide greater detail on what will be captured (e.g., training costs, healthcare utilization, time costs) and what economic outcomes will be compared.
6. Provide more justification for selecting a 10% sample for fidelity checks and discuss how variability across peer workers will be addressed.
7. Revise and polish table formatting (particularly Table 1) and remove duplicated content to improve readability.
8. Expand discussion of bias introduced by participant unblinding and consider strategies (e.g., blinded outcome assessment using third-party survey teams) for full trials.

Author Response

Thank you for the feedback on our paper. We have made the following revision which can be seen in the amended document as track changes.

 

Reviewer 1

Your feedback:  Although the study is framed as a feasibility trial, the choice of secondary outcome measures and their timing suggests a potential interest in assessing effects. This should be de-emphasized or discussed cautiously.

Our response: We have added the following text to the manuscript “We do not intend conducting any form of statistical analysis to determine the efficacy of the Back-on-Track intervention. “  

Your feedback: The control condition is a passive intervention with minimal interaction. While acceptable for feasibility testing, the lack of attention control may lead to overestimating acceptability and engagement in the experimental arm.

Our response: We have added the following additional text “Participants allocated to the control intervention will receive treatment as usual (primary care visits, antidepressant medication if indicated), weekly mood monitoring, and a guided self-help (Managing Stress on the Farm (MSOF)); representing the standard first-line treatment option for people with depression. An automated email directing participants to complete their mood rating will be sent weekly along with a reminder SMS sent to their mobile phone. MSOF provides tailored information, practical activities and links to further resources (including what to do in a crisis) to support the mental health of members of the farming community.

An attentional control – to address the non-specific effects of the experimental intervention - was discussed as an alternative comparator intervention. Although there are methodological advantages, we did not consider an attentional control to be consistent with our ethical obligation to ensure that participants were receiving standard of care (guided self help). That said, we acknowledge to potential that this will overestimate the acceptability of the Back-on-Track intervention.” 

Your feedback: The design is single-blinded (researcher-blinded), but participants know their allocation. The risk of performance and response bias is significant. This is acknowledged but under-discussed in terms of implications for data interpretation.

Our response: We have added the following text to address this issue in more detail:

We fully acknowledge that whilst single blinding is useful it does not eliminate the potential for performance and response bias. Participant and peer-worker awareness of group allocation could influence their responses to outcome assessments or decision about ongoing participation in the research. This is a common issue in clinical trials of novel psychological treatments. We will consider this important source of bias when interpreting out findings.   

‘As part of the consent process, a full explanation of the trial design will be given to participants including a description of the Back-on-Track (experimental) and MSOF (control) interventions. Consequently, participants will not be blind to group allocation (an open-label trial). Awareness of group allocation can impact how participants respond to the intervention they receive. Participants who know they have been allocated to the Back-on-Track experimental group may have more favourable expectations than those allocated to MOSF who may feel disappointed. Participants in the trial may assume that Back-on-Track will be better than MOSF. By telling participants which intervention they will receive may also influence how participants complete outcome assessments. It is also possible that knowledge of treatment allocation may also impact participant compliance and dropout from the study. It will be important when interpreting the outcomes of this feasibility trial to acknowledge the context within which the research was conducted.’       

Your feedback: The total training load (~76 hours) may reduce scalability and make replication challenging in less-resourced settings. Streamlining or modularizing training should be considered.

Our response: BA training typically takes around 56 hours to complete divided into a series of blocks that can be completed over a three-month period. Whilst a substantial commitment for trainees we have calibrated that this required amount to time necessary to ensure peer workers are able to deliver BA with a high degree of fidelity to the model

Your feedback: Recruiting 40 eligible participants out of 120–360 contacts (based on past data) may be difficult, especially with strict exclusion criteria (e.g., recent medication start). No contingency plan is described if recruitment targets are missed.

Our response: It is consistent in clinical trial of psychological treatments (with similarly strict inclusion criteria) for depression that 1 in 4 consent to participate in clinical trials. For clarity we have amended the recruitment strategy and predict number of potential participants that we predict will contact us will be around 200. We have also noted that we will monitor recruitment though our trial management group and modify our recruitment strategy if needed.  

We have developed additional recruitment procedures for recruiting community participants radio, social media, engagement at farming events, utilising networks of the community reference group.

Your feedback: While conflict of interest procedures are included, more detail on how peer-worker–participant compatibility will be optimized (e.g., gender, age, farm type) is needed for real-world deployment.

Our Response: We did not make any attempt to match peer-worker and participant experience and capability. Community reference group advised that this was not necessary.

Your feedback: While an economic evaluation is planned, the specific cost components and outcome measures for economic analysis are not well-articulated.

Our response: We have extensively rewritten this section of the manuscript. 

Your feedback: The formatting of outcome measure tables could be clearer (some values are misaligned or repeated).

Our response: Tables have been removed.

Your feedback: The manuscript is occasionally repetitive (e.g., describing PHQ-9 screening multiple times). 

Our response: The document has been checked to identify and remove and repetition. 

Your feedback: Clarify that the secondary outcomes are not powered for effect size estimation. Explicitly note this in the limitations section.

Our response: This has been noted in the manuscript.

Your feedback: To reduce attention bias, consider adding minimal contact (e.g., check-ins) in the control group for full-scale trials.

Our response: This issue was addressed through modifications and we have amended this in the manuscript.  

Your feedback: Explore and discuss whether elements of the training (e.g., asynchronous modules, micro-credentials) can be adapted for future scalability.

Our response: One of the aims of the feasibility trial is to determine the acceptability of the asynchronous training platform that can be used in a full trial and subsequent roll out of the approach, we have made this clear in the manuscript.

Your feedback: Add a fallback recruitment strategy (e.g., expanding geography or relaxing minor exclusion criteria).

Our response: We have addressed this in revisions.

Your feedback: Provide greater detail on what will be captured (e.g., training costs, healthcare utilization, time costs) and what economic outcomes will be compared.

Our response: We have amended the manuscript to address this point

Your feedback: Provide more justification for selecting a 10% sample for fidelity checks and discuss how variability across peer workers will be addressed.

Our response: We have amended the manuscript to address this point.

Your feedback: Revise and polish table formatting (particularly Table 1) and remove duplicated content to improve readability.

Our response: Tables have been removed as we concur, they were unnecessary.

Your feedback: Expand discussion of bias introduced by participant unblinding and consider strategies (e.g., blinded outcome assessment using third-party survey teams) for full trials.

Our response: We have addressed this in revisions.

Reviewer 2 Report

Comments and Suggestions for Authors

thank you very much it seems quite interesting and novel work. I have listed my recommendations:

1-)be careful about abbreviations in the manuscript. for example, BA 2-)authors can clarify the following sentence: pproximately 120 express interest to take part in the trial 3-)you can write the following concisely. Peer workers will be aged over 18 years and have demonstrated experience living or 127 working in a rural farming community. Peer workers may have personal experience of 128 mental stress or distress, or previous mental ill-health. However, this is not an inclusion 129 criterion for this trial. 4-)authors can add link as a reference. 5-)authors can add references to support Distress management protocol 6-)authors can add non-abbreviated version of PHQ 7-)you can add more information. for example adolescents aged () PHQ-9 is still considered an appropriate screening tool for adolescents (33). Comments on the Quality of English Language

acceptable

Author Response

Thank you for the feedback on our paper. We have made the following revision which can be seen in the amended document as track changes.

Reviewer 2

Your feedback: be careful about abbreviations in the manuscript. for example, BA

Our response: We have amended the manuscript to remove abbreviations

 

Your feedback: authors can clarify the following sentence: approximately 120 express interest to take part in the trial

Our response: We have amended the text for clarity

 

Your feedback: you can write the following concisely. Peer workers will be aged over 18 years and have demonstrated experience living or 127 working in a rural farming community. Peer workers may have personal experience of 128 mental stress or distress, or previous mental ill-health. However, this is not an inclusion 129 criterion for this trial.

Our response: We have redrafted the text for clarity.

 

Your feedback: authors can add link as a reference.

Our response: We are not clear what this comment relates to

 

Your feedback: authors can add references to support Distress management protocol

Our response: This has been added

 

You feedback: authors can add non-abbreviated version of PHQ

Our response: This has been added (line 170)

 

Your feedback: you can add more information. for example adolescents aged () PHQ-9 is still considered an appropriate screening tool for adolescents (33).

Our response: We added the following text ‘For example, in a validation study involving 2,235 students aged 12-18, year Fonseca-Pedro (33) showed the PHQ-9 was brief, easy and valid screening measure in adolescents.’    

Reviewer 3 Report

Comments and Suggestions for Authors

The manuscript reads like a proposal intended for an internal review board (IRB). In other words, it is not a completed study. It instead appears to be structured as a research proposal for a reviewboard, and it presents no actual findings.

While I could be mistaken, it seems plausible that the authors may have tweaked this manuscript from a proposal submitted to an IRB for ethical clearance. 

The authors may intend to later publish the actual study, once completed, in a more established and higher-ranked journal. This approach would effectively allow them to secure two publications from a single research effort.

Given the nature of the manuscript and its apparent purpose, I strongly recommend rejecting this submission.

1. The manuscript does not really address the main questions of the research because the authors are talking about what they will do, not what they actually did. Their proposal pertains to interventions for depression in farming communities mounted by practitioners who can be trained in a minimal amount of time. All worthwhile *if* the project had actually been executed.

2. It is not really possible to assess the originality of the project because the authors are not reporting what they did, but rather what they plan to do at some future date.

3. The subject matter looks like it would be interesting and important *if* the study were actually executed. However, the authors have not conducted a study but have merely offered an account of what they propose to do in the future, so they receive a failing grade here as well.

4. Once more, the methodology is hypothetical. The authors have not executed their study but merely proposed how they will execute it at some future date. So, while the proposed methodology seems okay, failing grades here as well since it has the study has not been executed.

5. Since the authors haven't executed a study but merely provided a proposal for the study they plan to do, one can't really assess whether the consistency of the conclusions aligns with data, arguments, etc. 

6. The references seem fine, but references without the study being executed do not add much value.

7. The manuscript appears to be nothing more than an IRB proposal for ethical clearance with a conclusion tacked on.

Comments on the Quality of English Language

Regarding me checking "the language could be improved" box, I pretty much always check this since language can always improved. So, this should be taken to indicate that the piece is not clearly written. That said, the piece is highly questionable for other reasons.

Author Response

Thank you for the feedback on our paper. We have made the following revision which can be seen in the amended document as track changes.

Your feedback: The manuscript reads like a proposal intended for an internal review board (IRB). In other words, it is not a completed study. It instead appears to be structured as a research proposal for a review board, and it presents no actual findings.

Our response: The manuscript is a protocol for a feasibility trial. There is a rich literature on the importance of publishing research protocols as part of the open science movement, see here for example. By publishing our protocol we aim to reduce the possibility of selective outcome reporting and publication bias.  

Your feedback: While I could be mistaken, it seems plausible that the authors may have tweaked this manuscript from a proposal submitted to an IRB for ethical clearance. 

Our response: The paper describes the protocol for a feasibility trial and is, as it should be, consistent with the application that we made for approval from the relevant Human Research Ethics Committee.

Your feedback: The authors may intend to later publish the actual study, once completed, in a more established and higher-ranked journal. This approach would effectively allow them to secure two publications from a single research effort.

Our response: It is entirely legitimate and indeed is considered good practice to publish the protocol and results paper sequentially. It is our understanding the IJERPH strongly supports publishing protocols as part of the journals commitment to open science.

Your feedback: Given the nature of the manuscript and its apparent purpose, I strongly recommend rejecting this submission.

Our response: Our purpose in submitting this manuscript for publication is to be open and transparent about the work we are doing in a manner that is consistent with best current practice.

Your feedback: The manuscript does not really address the main questions of the research because the authors are talking about what they will do, not what they actually did. Their proposal pertains to interventions for depression in farming communities mounted by practitioners who can be trained in a minimal amount of time. All worthwhile *if* the project had actually been executed.

Our response: The manuscript is a protocol of a trial i.e. it is a description of what we intend to do.

Your feedback: It is not really possible to assess the originality of the project because the authors are not reporting what they did, but rather what they plan to do at some future date.

Our response: We consider that we establish the scientific merit of the study in the back ground section of the manuscript.

Your feedback: The subject matter looks like it would be interesting and important *if* the study were actually executed. However, the authors have not conducted a study but have merely offered an account of what they propose to do in the future, so they receive a failing grade here as well.

Our response: None required.

Your feedback: Once more, the methodology is hypothetical. The authors have not executed their study but merely proposed how they will execute it at some future date. So, while the proposed methodology seems okay, failing grades here as well since it has the study has not been executed.

Our response: This is entirely the point of publishing our protocol. By registering our trial and publishing our protocol we are ‘locking’ what we intend to do. If we deviate from our protocol, we will need to report this in the results paper. In doing so we prevent the potential for selective outcome reporting which prevalent in clinical trials.  

Your feedback: Since the authors haven't executed a study but merely provided a proposal for the study they plan to do, one can't really assess whether the consistency of the conclusions aligns with data, arguments, etc. 

The references seem fine, but references without the study being executed do not add much value.

Our response: None required.

Your feedback: The manuscript appears to be nothing more than an IRB proposal for ethical clearance with a conclusion tacked on

Our response: None required.

We would encourage the review to read the following paper on the importance of pre-registration of research by Professor Nosek that can be accessed HERE

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

Thanks for the authors for considering reviewers' comments and recommendations.