Exploring the psychosocial needs of persons with lower extremity amputation and feasibility of internet cognitive behavioural therapy: a qualitative study

Abstract Purpose Following major lower extremity amputation (LEA), patients experience significant emotional distress and are at risk for anxiety and depression. There is a lack of mental health supports for this population, and internet-based cognitive behavioural therapy (iCBT) may be a useful resource to meet this need. The purpose of this study was to use a qualitative approach to explore the mental health needs of LEA patients and to gauge their attitudes of the use of iCBT to help them cope with their amputation. Methods Semi-structured qualitative interviews were conducted with inpatients and outpatients with LEA recruited from a major urban rehabilitation hospital. Data were analysed using inductive codebook thematic analysis (TA). Results Ten interviews were completed with individuals with LEA. The main themes identified were: (1) Fixating on the past; (2) Worry about the future; (3) Unmet mental health needs; (4) Barriers to Mental Health Support; (5) Importance of peer support; and (6) Tailoring iCBT. Conclusions Our findings highlight that patients with LEA are open to learning more about iCBT to meet their mental health needs. Key iCBT implementation considerations include taking into account issues of stigma associated with mental health, timing of delivery, levels of digital literacy, online security, and interactive content. IMPLICATIONS FOR REHABILITATION Following lower extremity amputation (LEA), people experience significant emotional distress and are at risk for the development of anxiety and/or depression. Patients with LEA are receptive to an online mental health resource (i.e., internet-based cognitive behavioural therapy [iCBT]) but it needs to be tailored to meet the various mental health needs and digital literacy of the LEA population. The use of an implementation science approach can help identify factors related to the development and potential uptake of an iCBT for patients with LEA.


Introduction
Losing a lower limb from trauma or disease is a life-changing event that affects the individual's mobility, function, physical health, and emotional well-being [1-3].In the United States, there were approximately 1.6 million persons living with limb loss in the year 2005, with the majority of the lower extremity amputations (LEA) being dysvascular in aetiology occurring due to complications from diabetes and/or peripheral vascular disease [4].The loss of mobility and change in physical appearance, along with secondary complications post-LEA, such as pain [5], can contribute to negative psychosocial outcomes, such as depression and/or anxiety [6][7][8][9][10][11]. Previous studies report that rates of depression following amputation can be as high as 60%, and that the prevalence of anxiety among post-traumatic amputees ranges between 25 and 57% [12].Both depression and anxiety are associated with poor outcomes post-LEA, including lower prosthetic use, lower self-esteem, higher perceived vulnerability, and lower self-rated health [6].
Despite the high rates of psychological distress noted in the LEA population [7-9], most rehabilitation programs typically focus on physical recovery with limited or no mental health resources.Even though patients may express a need for their mental health to be addressed [9], mental health is not always properly assessed nor treated during inpatient rehabilitation (regardless of population) [13].Further, mental health treatment options are not always accessible post-LEA [14].For instance, a study by Archer and colleagues [15] examining the unmet support services needs of people with lower-extremity trauma (N ¼ 545), including LEA, found that mental health services were one of the highest perceived need.The reason provided by participants was that they believed they would get better on their own or that they did not know where to go.The lack of resources to address mental health post-LEA is a significant gap in care, and there is a need for more strategies and resources to help individuals cope with their limb loss.
One promising approach that is widely regarded as effective for treatment of mild to moderate levels of depression and anxiety is cognitive behavioural therapy (CBT) [16].CBT is a shortterm form of psychotherapy that uses a structured, problemfocused, and goal-oriented approach to provide clients with practical strategies and skills to enact positive change in wellbeing [17].Unfortunately, the ability to access in-person face-to-face CBT may be limited due to factors including geography, mobility, provider availability, and cost.
A possible strategy for circumventing barriers to the delivery of CBT while also expanding its availability to the limb loss population is the Internet since it has a greater potential to reach more individuals than traditional face-to-face CBT [18].Internet CBT (iCBT) is comprised of virtual therapist contact (i.e., feedback, encouragement, and occasional therapeutic activities), as well as interactive treatment modules [18].Furthermore, iCBT can allow for a more dynamic approach to meet a wide range of users since it can incorporate a variety of multimedia besides text-based approaches (i.e., audio and video files) [18], and modules can be tailored to provide content for specific diseases [19,20].There is a high level of evidence for the feasibility and effectiveness of iCBT, with several studies demonstrating that it improves anxiety and depression experienced in patient populations with chronic disease [21][22][23][24].iCBT has also been shown to be effective in the treatment of psychiatric and somatic disorders [25], as well as the management of pain, disability, and fatigue associated with chronic illness [26][27][28].
Some noted challenges associated with iCBT, include outlining treatment delivery standards and monitoring outcome measures in a clinical setting [29].Furthermore, some iCBT programmes are not always synchronous, and the lack of therapist interaction can make it difficult to adapt treatment to the patient's progress [30].Such challenges need to be considered for optimal implementation and effect.Regardless of these issues, there is promising evidence highlighting the potential of iCBT for meeting the mental health needs of the LEA population [18][19][20][21], which has prompted our team to plan the development of an evidence-based and patient-oriented iCBT program for this population.
Despite the promise of iCBT, its application with patients with major LEA has not been fully explored, nor to the best of our knowledge, no iCBT programs specific for this patient population exist.Hence, an important first step in this process is to obtain the perspectives of persons with LEA to learn about their particular psychosocial needs as well as their receptiveness to using iCBT as a tool to address their mental health needs.Interviewing individuals with LEA may provide insights regarding the appropriate content of an LEA iCBT program but also key implementation considerations to maximize uptake and usage of a developed program.Hence, the purpose of this study was to interview persons with LEA about their mental health needs and to gauge their attitudes towards iCBT and/or online mental health supports.Given the high rates of psychological distress following LEA and the lack of available mental health resources for this population, developing interventions that can be introduced early post-LEA is critical in the prevention of long-term psychological disability [31].

Methods
A qualitative descriptive design was used for the present study [32,33].This method was selected since there are limited studies in the area, and the concepts of interest (mental health post-LEA, iCBT awareness, and acceptance) would be best addressed by obtaining in-depth information from participants within their everyday contexts, as participant perceptions are considered to be accurate reflections of the reality of the phenomenon being examined [32,34].Ethical approval for the study was obtained from Sunnybrook Health Sciences Centre Research Ethics Board.

Theoretical framework
This study was theoretically guided by the Consolidated Framework for Implementation Research (CFIR; Figure 1) [35].The CFIR is an implementation science framework that integrates concepts from various published implementation theories [35].It outlines various domains that can serve to identify and influence the introduction, implementation, and effectiveness of an intervention [35].
The CFIR domains include "Intervention Characteristics," which addresses factors related to the intervention itself in terms of its' adaptability, complexity, cost, etc.There are also "Outer Setting" and "Inner Setting" domains, whereby outer setting factors are those that are beyond the control of the organisation, such as external policies or incentives that affect its implementation as well as patient needs."Inner Setting" factors are those that are relevant to the organisation implementing the intervention, such as the structural characteristics of the organisation as well as its' culture.The "Characteristics of Individuals" domain takes into account issues related to the individuals who are responsible for implementing the intervention, such as their knowledge and beliefs and/or self-efficacy to deliver the intervention.Finally, the "Process" domain accounts for ways to introduce and refine the intervention by identifying local champions and establishing of metrics on the effectiveness of the intervention to inform decision-making [35].Where applicable, domains of the CFIR were referred to for developing our interview guide (Supplementary Appendix A) to help our team identify relevant implementation considerations of an iCBT tool.

Participants
The inclusion criteria for the present study were English-speaking adults (18 years or older) who had a major LEA (transfemoral, knee disarticulation, transtibial, or ankle disarticulation) within the previous 5 years due to dysvascular (complications of diabetes/ PAD), trauma or other aetiologies (e.g., cancer, infection, etc.) who were either inpatients or outpatients at Sunnybrook St. John's Rehab Hospital -an urban rehabilitation centre that provides specialised amputation rehabilitation care in Toronto, Ontario, Canada.Individuals with amputations acquired at age younger than 18 years of age or due to congenital limb deficiencies were excluded.Individuals with significant mental health diagnoses and/or cognitive impairments were also excluded.

Data collection
Recruitment posters and clinician referrals were used to identify potential participants.Participants who consented to learn more about the study were screened for eligibility, completed the informed consent process, and then underwent brief semi-structured interviews that lasted approximately 1 h.The interviews were conducted either in-person or by telephone by the same person who recruited them into the study.Data were collected between November 2019 and September 2020.All interviews were audio-recorded, transcribed verbatim, anonymized and checked for accuracy by the member of the study team who collected all the data.Participants were thanked for their time and provided with a $10 gift card as a token of appreciation.Throughout the recruitment and data collection process, standard operating procedures to ensure the ethical treatment and wellbeing of our participants were followed, which included referrals to clinical members of our team to provide mental health supports if and when needed.

Data analysis
The interviews were analysed using Codebook Thematic analysis (TA) as described by Braun, Clarke, Hayfield, and Terry [36].This approach is characterized by the use of a coding framework, and the belief that data need not be "accurately" summarized, but rather, reflexively and subjectively interpreted by researchers [36].While Codebook TA is not used to facilitate inter-rater agreement, it is used to pragmatically facilitate the process of having multiple data analysts code a dataset [36].Analysis using this approach proceeded in a stepwise fashion [37].Interview audio recordings were transcribed and reviewed independently by three of the authors [SG, VF, SLH], and a coding framework was subsequently created.Following this, two authors independently coded the data using this codebook [SG, VF], and met with a third author to organize preliminary codes into broad groups [SLH], and to integrate new codes into the codebook as analysis progressed.Regular peer debriefing meetings with a third author [SLH] to review identified themes to determine which ones needed to be refined, broadened, or eliminated in light of how readily they adhered to the data set.Lastly, themes were finalized, named, and defined by all the authors and a detailed audit trail was maintained to document the criteria by which the data fit each theme.
The COVID-19 pandemic disrupted data collection efforts with most of the data being collected just prior to the first wave (9 of the 10 participants having their data collected before March 2020), but the authors agreed that the degree of common issues cited by the participants, and the resulting "information redundancy" [38] across the interviews indicated that saturation had been achieved.

Results
A total of 12 persons consented to be approached to learn about the study with 10 of them providing consent to be interviewed.The sample consisted of 9 men with a unilateral LEA (2 dysvascular, 3 traumatic, and 1 due to necrotizing fasciitis) and 1 woman with bilateral dysvascular amputations.See Table 1 for a full description of the sample.
From the analysis, six main themes and accompanying subthemes were identified.This included: (1) Fixating on the past (2)

Fixating on the past
For many participants, limb loss was associated with a tendency to fixate on the past, whereby individuals questioned and worried about whether they would retain their previous identities and abilities.For some, such reminiscing led to mental health difficulties, such as depression and anxiety, as well as emotions such as frustration.
Interviewer Another participant reported feeling "devastated" after confronting his new reality with a leg amputation, especially in light of formerly being athletic, and assuming his adjustment back to "normal" would be easy.
Devastated.Because it's sinking in.Well it's one thing to say 'Well okay, you saved my life" but it's another to wake up and find half your leg missing, and you have to start wrapping your mind around the rest of your life, how are things going to go … None of it was very clearly explained.My biggest criticism is that nobody explained to me how the rest of my life would go.All the doctor said was "oh don't worry, well you're younger, you're reasonably athletic, you'll get a prosthetic leg, and you'll go on with life."So in your head you think life's just going to go back to normal after surgery.You know, after 6 months after rehab you'll be walking away and everything's normal.But that's not how it goes.I'd say that part wasn't explained very well.(ID#20, male outpatient, age 52, dysvascular aetiology) Conversely, one person reported that fixating on the past did not trigger difficult emotions but rather served as a mechanism to cope with her anxiety and depression.Lastly, participants reminisced about their past occupations and identities, questioning (at times, with frustration), how such roles would change in light of an amputation.I'm supposed to try to function as a working chef in a kitchen with a wooden goddamn foot?No, I can't do that either!!This is all -It's all connected as part of the mental health picture but there's nobody to talk to about that and nobody's got any solutions!(ID#22, male inpatient, age 43, dysvascular aetiology).
Your identity.You hit the nail on the head with that last one.Because some people identify themselves as a sports person, some people identify themselves as a worker.Now those identities have been shattered.(ID#20, male outpatient, age 52, dysvascular aetiology).
Regardless of aetiology, the experience of limb loss prompted participants to reminisce on the past, which, at times, led to mental health difficulties, such as anxiety and depression as well as intense emotions such as frustration.

Worry about the future
A number of participants felt preoccupied with worry about the future in light of losing a limb.Most notably, worries centred upon a) being discharged back into the community b) finances; and c) functional independence.

Being discharged back to the community
Participants discussed that the biggest factor weighing on their minds and causing distress was the uncertainty of what the future might bring; especially once they were to be discharged back home to the community, with one person stating "Well, I was concerned about the surgery.

Financial cost
Participants found the financial impact of limb loss very stressful, including the cost of a prosthesis and other services to maintain health, wellbeing, and independence in the community.One participant remarked that they received no information about the financial costs of having an amputation, and that more transparency around this may impact one's decision to have an amputation in the first place.
A lot of the costs were shocking to me … There was no mention of this.Like if you were in financial hardship that may have impacted the decision about having the amputation.If you knew that just to get back to the basics would be 10 thousand dollars out of pocket, for some people that would be a deal breaker.(ID#24, male inpatient, age 51, dysvascular aetiology).

Functional independence
With regards to mobility and functional independence, patients talked about the challenges of being able to move around independently and some discussed fear of falling.One patient commented: "But you know, my biggest fear, I think it's sort of subconscious, but my biggest fear is of falling."(ID#15, male outpatient, age 47, dysvascular aetiology).More broadly, patients talked about concerns of what it meant to move around the community.
Right, like imagine if you were driving, your employment was contingent on driving.You're driving a bus, a truck or a commercial vehicle of some type and now you can't.Now your means of employment has been completely removed right?… .So I think there are sort of a lot of cascading issues that would lead people to mental health concerns.(ID#24, male inpatient, age 51, dysvascular aetiology).
See when you become an amputee, your life just changes.Now you can't get around, or you can get out but now you can't because of the weather.I'm in a wheelchair and it's not made for snow.(ID#18, female, 65, dysvascular aetiology).
Overall, the sub-themes describe how many participants encountered and became preoccupied with worry about returning home, financial costs, and functional limitations; all of which they anticipated experiencing in their near future.

Unmet mental health needs
Several patients commented they felt that providers did not prioritize their mental health throughout their journey of care of undergoing an amputation, with a few mentioning it was never discussed.
Zero.It was never talked about … .Never.'How are you feeling mentally today [Name]?' Nobody's ever asked me that.It was coordination with community care, it was getting my funding for my wheelchair, getting my funding for my prosthetic … They get all the stuff together that I'd need so that they can get me out the door.Mental health?They don't have time for that.I'm only here for two months.If I am broken in the head, they're not going to be able to fix that in the two months that I'm here.(ID#22, male inpatient, age 43, dysvascular aetiology).
One participant reported that when he asked about his referral to receive mental health support, staff offered him little information, and rather than following up on this matter, they offered him medication instead: They didn't do it [referred me to someone].So even I did ask again to follow up to see what happened with that guy, with that person to talk about, I didn't follow up so they just gave me that pill.(ID#17, male outpatient, age 51, traumatic aetiology) Some participants reported that supports were provided during their inpatient rehabilitation, including visits and/or referrals to an inpatient psychiatrist or social worker, or visits from spiritual care staff and/or referrals to external mental health supports.However, participants also indicated that such support was not offered at the level they were hoping for or not in the way they preferred.
And then the first psychiatrist that saw me right away I didn't like him, right off the bat.I'm not going to mention the name, 'read the book, read the book.'That's not what I'm looking for, I have a lot of things I want to talk about right?(ID#16, male outpatient, age 58, dysvascular aetiology) The overwhelming view by the participants was that the priority for rehabilitation was on the restoration of their physical functioning and the more tangible functional aspects of returning to the community.Conversely, mental health support was either not addressed at all, or was acknowledged by healthcare providers, but oftentimes left participants feeling as though they needed further support.

Barriers to mental health support
Multiple participants remarked on barriers they experienced in seeking mental health support following LEA, including issues around eligibility, finances, and treatment fatigue.
One participant explained that he did not receive much mental health support, or "attention" due to a perceived lack of severity regarding his health.In this regard, the scarce mental health resources were not allocated to him.… Because that was kind of the general thing at rehab too, there's always more demand than there are resources.I'm pretty able bodied and healthy, I have no co-morbidities so I was deemed to be pretty safe in rehab, I wasn't going to fall over and break my head.So they didn't pay a lot of attention to me in some respects.(ID#19, male outpatient, 53, necrotizing fasciitis).
In addition, one participant discussed that financial considerations are also central when navigating the search for mental health support following limb loss, and that one must be strategic in their search when they do not have the economic means to access services more freely: "So while I cannot work period, I told myself, 'I think it's time I tried to talk to somebody, try to grab whatever's free.'It's easy to go and pay for it, but when you don't have the income, there has to be a way."(ID#16, male outpatient, age 58, dysvascular aetiology).
Lastly, one participant reflected on the burden associated with managing his numerous healthcare appointments, and that mental health counselling added to the 'tiresome' nature of this demanding schedule.
But I think at that point I've never really truly been through any kind of meaningful counselling before.So there's a period of time where you have to learn how to be a counselling patient in a way.But I don't think there was anything that was terribly unhelpful, except at some point I was growing weary of all the appointments.So if it wasn't psychiatrist appointments, it was medical appointments, and follow-ups, and rehab sessions and starting back at work.It was almost becoming a little bit tiresome.(ID#19, male outpatient, 53, necrotizing fasciitis) Based on the struggles in navigating eligibility, financial preparedness and treatment scheduling, participants felt that their current access to mental health support was limited after experiencing a LEA.

Importance of peer support
All the participants discussed the importance of being able to connect with limb loss peers to help them with their recovery, with one person saying: The best thing would be for them to do would be to get help, you know, sit with maybe other people, or talk to somebody who has gone through it long before they did, and get their ideas and sit back and think about what they have gone through before you lost your leg.(ID#18, female outpatient, age 65, dysvascular bilateral limb loss) Through their interactions with peers, participants commented that they learned important tips about their amputation (e.g., residual limb care, getting their licenses back, etc.) and viewed the information from the peers as being credible, which also fostered a sense of community.One participant noted: There were a lot of questions in my head because at the same time we're on a ward with other amputees right?And obviously at my age I'm older and you hear a lot of the stories, right?And that's what's cool about having a group for amputees.(ID#16, male outpatient, age 58, dysvascular aetiology) For some, speaking with peers removed some of the stigma associated with mental health, with one person stating they would prefer to be connected to a peer over a mental health specialist: A peer.Psychiatrists scary people.You don't want to be hanging out with a psychiatrist, and be labelled as crazy, right?Why do you need to see a psychiatrist?Well because I'm crazy (ID#20, male outpatient, age 52, dysvascular aetiology).
By reflecting upon the need for social connection, informational support, and hesitancy to interact with mental health specialists, it is apparent that many participants would value having access to an informational and supportive peer network.

Tailoring iCBT
Half of the participants were familiar with iCBT, with one person participating in a CBT programme prior to their amputation.Almost all the participants were open to learning more and/or trying an online mental health program, with one person stating: "I think it could be a hugely useful resource if it's done properly and has the right information and the right resource.It would be a game changer, because everything is online now" (ID#22, male inpatient, age 43, dysvascular aetiology).Only one person (ID#18, female outpatient, age 65, dysvascular aetiology) was not all interested in using a computer due to lack of access to one.From the subsequent questions about the use of mental health resources post-amputation (with some specific to an online resource), as well as from other issues related to access and perceptions of mental health supports, individualized considerations relating to stigma, timing of delivery, levels of digital literacy, online security and interactive content became apparent.
Despite participants recognizing the need for mental health resources, there appeared to be sensitivity regarding how "mental health supports are introduced," with some commenting that supports should be tailored to ameliorate stigma.
Participant: Well you say mental health and people say 'Mental health, I'm not a nut bar, I don't need to go!' But he doesn't realize that encompasses … you know … (ID#21, male outpatient, age 59, traumatic aetiology) One participant indicating the preoccupation individuals have with normalcy and that they will go to lengths to appear that they are not in need of mental health support: I think that we spend a great deal of our life trying to look normal and learn to hide things.We say things are fine and we become very good at hiding things.People don't want people to see them acting crazy or depressed or weird, so people become very good at hiding things.(ID#20, male outpatient, age 52, dysvascular aetiology) Despite such concerns and sensitivity, participants were receptive to having healthcare providers facilitate one's receipt of mental health support.One participant stated that online mental health support could be tailored by having a doctor or nurse or even a "computer specialist" introduces the programme (ID#17, male outpatient, age 51, traumatic aetiology).Additionally, there was discussion that the online program could be presented at different times depending on one's amputation aetiology.For example, one participant indicated that supports could be introduced earlier for those with dysvascular conditions who are at risk for amputation.So in our peer counselling training, they always say that one of the best times for peer counselling session is before an amputation.Or even before the person is having to make a decision so you can help them be informed.In this case I would say from a mental health perspective, there would be a value of at least a portion of it or a module of it addressing that audience.(ID#19, male outpatient, 53, necrotizing fasciitis) ----------------------------------------------------"Maybe before the surgery because of all the anxieties I had" (ID#15, male outpatient, age 47, dysvascular aetiology).
It was apparent that participants recognized that people with LEA have varying needs and capabilities related to their mental health and digital literacy.As such, people noted that any online mental health resources should be tailored to ensure they are accessible to persons who may have lower levels of digital literacy (or challenges accessing appropriate equipment).With regards to assistance using an online program, one person said they would need initial support before using it "But if I had a person who understands these programs really well and sat beside me to show me, I'd feel comfortable.Someone who understands it" (ID#15, male outpatient, age 47, dysvascular aetiology).
To mediate the technical demands of an online mental health program, participants suggested that the program should have a set time frame (i.e., approximately a few weeks in length and each individual module 1 h in duration).With regards to one's unique needs post-amputation, one person commented that: Well I think it would be good to have a preliminary questionnaire to figure out each person's individual needs and then steer them towards the adequate resources.You're suffering a mental loss, you're WSIB (Workplace Safety and Insurance Board) case so finance isn't an issue for you, you fall into the mental health area because you're having trouble dealing with the loss of your limb so we'll steer you towards these resources.Or … You're mentally prepared for your limb loss and you're dealing with it well, your issues are financial so we're going to steer you toward these resources.(ID#22, male inpatient, age 43, dysvascular aetiology).
As well, some participants were receptive to being able to connect virtually with peers as part of the programme.Interestingly, almost all the participants commented that "privacy was not a concern," which was steeped in an understanding of how much the world now relies on the Internet for a variety of reasons in people's daily lives, and the inherent risks with it.One person stated: "Nah, I've been online enough.There's no privacy anymore" (ID#22, male inpatient, age 43, dysvascular aetiology).Overall, the sample felt that with sufficient safeguards, their online privacy would not be at high risk.
With regards to the "content," people talked about having a variety of educational information that they could access, and tailored to have it available in ways that were engaging to them, which may include the use of interactive, activities and quizzes, and videos.So I have found in my experience that I'm much more likely to use but more importantly to get value from something that has an interactive component.So if it's presenting some information, have some kind of activity or quiz or something at the end of it to help lock in the key points.(ID#24, male inpatient, age 51, dysvascular aetiology) Overall, tailoring online mental health support for individuals with LEA may be guided by individualized considerations and preferences surrounding mental health stigma, timing of delivery, levels of digital literacy, online security, and programme content.

Discussion
The main findings from this study indicate that individuals with LEA may fixate on their past identities and abilities, as well as worry about their futures in terms of being discharged, financial costs, and retaining functional independence.The need for additional mental health support and peer support is also expressed.
Participants expressed being open to learning more about iCBT, but their comments also highlighted the importance of considerations relating to stigma, timing of delivery, levels of digital literacy, online security, and interactive content.
A qualitative meta-synthesis on the experiences following amputation and prosthetic use among adults echoes many of our findings, including how individuals with an amputation often experience sadness, anger, fear at their perceived losses, and a preoccupation with uncertainty about the future [37].Concerns about the loss of functional independence and the importance of the social facilitation of adjustment and coping have been explored in this population [39].Our study results also highlighted how a person's identity and ability to engage in different occupations changes in response to a LEA, and the literature elaborates upon this by providing evidence that identities can also be dictated by prosthetic acquisition and the regaining (as opposed to loss) of occupational skills [37].
Given that the larger scope of this work is to inform the development of an online mental health iCBT resource for patients with LEA, the identified themes have been contextualized within the CFIR framework [35] to extract key implementation considerations to inform the design and delivery of the proposed system (Figure 1).In particular, the CFIR's domains most pertinent to our findings include "Outer Setting," "Intervention Characteristics," and "Inner setting" elements of the framework (Figure 2).
With regard to CFIR "Outer Setting" characteristics, which refer to external influences on an intervention implementation, the sub-construct of "patients" needs and resources' is the most relevant to a number of our themes.Specifically, our findings highlight that patients with LEA experience a number of mental health challenges that require further support.Many patients expressed feelings of depression, anxiety, and anger as a result of their experiences of undergoing LEA, which is a major life-altering event.These difficulties are consistent with previous findings in the literature [6][7][8][9][10][11].The development of an online or iCBT mental health programme would be of value to help meet the mental health needs of this patient population given that many participants commented that despite receiving some supports, they were not at the level or in the format they were hoping for.Again, the lack of prioritization of mental health during amputation rehabilitation has been previously reported [13].
The lack of prioritization of mental health aligns with the CFIR Inner Setting sub-construct of "relative priority," which speaks to the shared perception of staff working at the organization regarding the importance of implementing an intervention.This finding that patients recruited into our study found that their mental health was not prioritized by providers was a bit surprising since the hospital site where participants received care was staffed with mental health specialists, such as social workers as well as two onsite psychiatrists which is uncommon for rehabilitation hospitals in Canada.However, at our institution, only patients with high-level mental health needs are referred for psychiatry consultation, so the participants' experiences of inadequate mental health focus and support may reflect an internal barrier in accessing the supports.There are also a number of factors that may influence length of stay for inpatient rehabilitation (i.e., advanced age, cognitive impairment) [40], with one study reporting the average length of stay for their limb loss inpatients being 63.6 ± 33 d [40].At our site, the average length of stay is approximately 4 weeks (28 d), which substantially reduces the opportunity for effective multidisciplinary intervention.Consequently, there is a recognized need for mental health supports post-amputation at the organizational level where this study took place and the proposal of an adjunct iCBT program would likely be well-received to maximize use of existing mental health resources.Additionally, under-resourced sites may welcome an Internet-based mental health resource as it might fill a critical health need if the costs were low enough.
A number of our findings can be contextualized to the CFIR's "Characteristics of the Intervention" in that the intervention needs to take into account adaptability, complexity and design quality, and packaging considerations.First, the majority of participants were open to using an online iCBT mental health programme, and not overly concerned about privacy issues, but stressed that it should be adapted to their varying needs and digital health literacy.Digital literacy in older adults can present a barrier [39], which is of relevance given that most people with dysvascular aetiologies are older adults (65 years and older) [41].As well, health literacy following amputation has been found to be quite poor, and particularly for those with dysvascular amputations [42].As such, our theme "Tailoring iCBT" reinforces that the final system should include content and features that may be customizable to end-users' particular needs.This includes ensuring that the content is engaging and interactive (e.g., use of multimedia), that it is time-limited (a few weeks with brief modules) and that "technical" support can be provided to ensure that users feel supported when starting to use it; thus reducing the complexity of using the system.
In terms of the specific content modules, one of the main foci for our group was to help address depression and anxiety in this patient population, which are ideal targets for iCBT in persons with chronic conditions [19][20][21][22][23][24][25][26][27][28].However, through our interviews, specific domains contributing to mental distress included issues around finances and mobility (functional and across the community), which were linked to feelings of uncertainty of what life was like post-amputation and/or post-rehabilitation hospital discharge.For instance, the issue of finances is important given that others have noted that financial difficulties post-limb loss is associated with poorer health and wellbeing [43], and addressing factors associated with poorer mental health outcomes may help to prevent and/or minimize feelings of depression and anxiety.Similarly, another qualitative study highlighted that gains in mobility (even modest ones) following the prescription of a prosthetic was tied to greater feelings of independence [13].In general, there are many stressors associated with the post-LEA period and including non-"mental health" topics, such as mobility, wound care, and other life situations affected by limb loss, may de-stigmatize the introduction of a mental health support resource to patients.
The remarks from our sample regarding the uncertainty of what comes next following hospital discharge suggests that introducing this system during rehabilitation may be ideal since transitioning from inpatient rehabilitation to the community is consistently reported by patients with a mobility impairment as overwhelming, compounded by a lack of formal preparation [44].For people with lower limb loss, inadequate social support has been found to be associated with poorer outcomes [40]; especially if they live alone or are discharged to an inaccessible environment [45].However, once a system is created, professionals, such as vascular and/or orthopaedic surgeons, could also refer their patients to this resource to help patients psychologically prepare for what life may be like following amputation.As such, these qualitative findings provide some important insights into amputation-specific domains that the program may wish to address.
Finally, we constructed the significant theme of the value placed on peer-support.In relation to the CFIR, the sub-construct of "engaging" patients in the use of an iCBT online program may be peers, and are likely ideal 'external change agents' to influence patients decisions around engagement.Peer support post-amputation is widely seen as being favourable for influencing outcomes, and is of low cost and low risk [46].Further, using peers to help introduce the iCBT programme may de-stigmatize the use of the program while also elevating the perceived credibility of the programme.
A limitation to our study was that only one woman was successfully recruited.This is not surprising given that the majority of LEA is male [41].Some notable differences between men and women with LEA include that studies show that women are less likely to be fitted with a prosthesis and more likely to live alone than men [47], as well as have higher reporting of body image issues than men [48].As well, several studies report women with limb loss have lower quality of life than men [49][50][51].These differences express the need for future research to ensure that both sex and gender are taken into account as the iCBT programme is developed.
Another limitation was that participants were recruited from an inpatient rehabilitation hospital in a large urban setting that provides a higher level of physical and mental health supports than, to the best of our knowledge, typically seen across the rest of the country.Access to inpatient rehabilitation and/or specialized mental health specialists is unfortunately not uniformly available across Canada.One of the goals of our proposed programme is to broaden access to mental health supports.Given some of the noted challenges with health and digital literacy, an implementation consideration may be to initially develop a system geared to inpatient rehabilitation settings, and then work to expand accessibility to less resourced communities to better understand which patients are more receptive to using it, and what facilitates uptake and usage.Once more evidence is collected regarding its implementation and efficacy; efforts could be directed to finding ways to translate it outside of hospital walls.
It should also be noted that not all domains of the CFIR were touched upon, which may limit our understanding of all the implementation considerations for an iCBT programme for patients with LEA.However, the use of an implementation science framework (i.e., CFIR) was useful for sensitizing our interview guide questions to extract what factors may impede or facilitate the design and introduction of a novel iCBT programme for LEA, which will help increase the success of future uptake and spread [52].
In summary, this study illustrates the usefulness of taking an implementation science-informed approach to inform the development of an iCBT mental health programme for the LEA population.The initial step of speaking to people with LEA is a critical first step for ensuring that the final product will be patient-oriented and relevant to their mental health needs.Future work will focus on developing a prototype system and to gain further input from patients as well as clinical staff on the refinement of the iCBT programme.Incorporating both patient and clinical perspectives may create a more comprehensive picture of the implementation domains (i.e., process elements) of an iCBT mental health programme.
Interviewer: If they didn't offer any support, how did you cope if you were feeling anxious or stressed or other feelings?How did you cope with that?Participant: "I'd just sit back and think of things I could have changed my life with."Interviewer: "So you found yourself looking backwards you mean?In terms of regrets or what could have been done differently?"Participant: "Yeah."(ID#18, female outpatient, age 65, dysvascular aetiology)

Table 1 .
Participant characteristics.Tailoring iCBT.These themes and sub-themes are described below with sample quotations used to illustrate the theme.To secure anonymity, quotations include only participant gender, amputation diagnosis, age, and their study identification numbers.
BKA: below knee amputation; AKA: above knee amputation Worry about the future (3) Unmet mental health needs (3i.Discharge; 3ii.Finances; 3iii.Functional independence); (4) Barriers to Mental Health Support; (5) Importance of peer support; and (6) : Right so you said that one of the things earlier that made you feel depressed was thinking about how this might change your life.So that would address that kind of anxiety-seeing examples of other people who have gone back into their regular life?
Participant: Everybody's looking to the past, how they used to be.Uh … .So for me, you go to wedding and you see someone is dancing all night.I was that guy.Can I dance again all night?I had a tree at my cottage.A poplar, it was 40-50 feet tall.I climbed way over there with a chainsaw in my hands so I chop it down.Can I do that again?(ID#17, Male outpatient, 51, traumatic aetiology) That was my biggest worry.And then what would come after and when I could get home."(ID#25, male outpatient, age 77, traumatic aetiology), and another stating: I'm worried about how I'm going to get around.I'm worried about not being able to find a job because I can't get around.I'm worried about losing my house because I don't have money.I'm worried about getting the right foot on the end of my stump so that I can do my job … (ID#22, male inpatient, age 43, dysvascular aetiology) Whether it's bills, and having to battle with Ontario works, or waiting for your ODSP fOntario Disability Support Programg paperwork to come back.Not being able to work.Worrying about my house being taken away.[voice wavers] So what … Where am I going to live? … If I can't work … Because I can't drive … Because they took my f ��� ing license away and now I've got to wait 3 months to get it back.And I've got to pay a thousand dollars for the assessment and I've got to pay a thousand dollars for the device to be put in my car.Where is all this money going to come from when I can't work?And I get $150 a month from Ontario Works?Whoop-de-doo, that's a tank of gas and a case of beer!Thank you very much![sarcastic clapping] (ID#22, male inpatient, 43, dysvascular aetiology)