This project comprises two parts: (1) semistructured exit interviews and (2) co-design meetings. Qualitative exit interviews were conducted with patients and caregivers during a discharge session after they received the GET Living intervention as research participants. Subsequent co-design meetings were held with the patients and caregivers as research partners to refine the intervention in a formative research process.

This project involves 2 separate examinations of GET Living: one was a single-arm trial (Boston trial) and the other was an RCT (Stanford trial). The Boston trial (NCT01974791) used a sequential replicated and randomized single-case experimental design (SCED) with multiple measures evaluate the effect of GET on youths with chronic pain for the first time [7]. The Stanford trial (NCT03699007) used a 2-group RCT enhanced with SCED elements to compare GET Living with a traditional multidisciplinary pain management approach [10]. The former GET Living participants had a unique expertise in what it is like to undergo pain exposure treatment from a patient’s and caregiver’s perspective.

In the Boston trial, patients were recruited from the Pain Treatment Service at Boston Children’s Hospital between December 2013 and February 2017 (data collection was completed in January 2018). In the Stanford trial, patients were recruited from the Pediatric Pain Management Clinic at Stanford Children’s Health from January 2019 to May 2021 (data collection was completed in January 2022). Treatment providers referred patients to GET Living during clinic visits. A study flyer and additional brochures were also available in the patient waiting room for patients to self-refer to the study. Patients were deemed eligible to participate in GET Living if they were aged 8 to 17 years, had a diagnosis of chronic pain, had moderate to high pain-related fear, and had moderate to high functional disability [7,10].

Interview data were analyzed to identify themes related to treatment change processes. In addition, interviews were conducted to create a pool of ideas for intervention improvement and helpful treatment elements, which were later ranked and discussed in the co-design meetings.

Only the patients and caregivers who completed all treatment sessions were included in the qualitative analysis to ensure that the data were reflective of the entire treatment experience. The interview that was conducted with a patient and their caregiver who withdrew their participation was excluded. Both the patient and caregiver felt that the treatment’s focus on pain and anxiety was not a good fit. In the Boston trial, 26 interviews of patients and caregivers were analyzed. In the Stanford trial, 26 interviews of patients and caregivers who were randomized to the exposure intervention were analyzed. The patients and caregivers were interviewed separately. More details on the interviewed cohorts are presented in Table 1.

The semistructured exit interviews were conducted by research assistants during the discharge visit following the completion of GET Living. All research assistants were trained by the principal investigator LES. In the Boston trial, most interviews were conducted in person. In the Stanford trial, most interviews were conducted via phone or video calls. The patient and caregiver interview schedules both comprised 8 questions (Multimedia Appendix 1). The questions were intended to capture the positive (eg, question [Q] 1: “What did you like the best about GET Living treatment?” “What was the most helpful?”) and negative (eg, Q2: “What did not help?” “What would you change?”) experiences that the families had during their treatment. The participants were also encouraged to give their critical feedback through several questions (eg, Q3: “What do you wish you had known before starting GET Living treatment?”). Other questions targeted to capture treatment change processes, that is, the changes that the families experienced in themselves (eg, Q4: “What did you learn about yourself and your family in GET Living treatment?”). The interview schedule questions guided the conversation; however, consistent with the semistructured nature of the interview, the participants were also provided with space to share additional feedback about their experiences.

Reflexive thematic analysis [21] was used to assess the participants’ perspectives and identify common themes across the interview data. Consistent with constructivist epistemology, reflexive analysis allows for the cocreation of knowledge between the participants and researchers. Subjectivity is not seen as a potential threat to the “truthful” or objective meaning of the data but is rather conceptualized as an analytical resource for data interpretation [22]. Data analysis was led by an investigator (LS) who was not involved in the data collection or intervention delivery. The analysis was conducted by following the 20-question guide by Braun and Clarke [22].

To begin data analysis, the investigator became familiar with the data by repeatedly and actively reading 12 fully transcribed interviews and listening to some randomly selected interviews. For the subsequent coding process, analysis was conducted on the audio recordings of interviews instead of the transcriptions to capture richer, more nuanced (eg, tone and affective aspects of responses) aspects of the participant responses. While listening, the investigator entered detailed notes of the codes for each interview into a comprehensive overview table. Relevant quotes were fully transcribed. Throughout the data analysis, the first author (LS) incorporated semantic features of the data (ie, explicitly stated ideas, concepts, meanings, and experiences) as well as latent features (ie, implicit meanings underlying explicit statements) when defining codes and themes. The generated codes were then clustered into candidate themes. This analytical process focused on the development of themes related to treatment change processes throughout the GET Living program. Theme identification occurred through an iterative process, whereby 2 authors (LS and LES) identified and refined codes and illustrative quotes until deep and nuanced themes regarding change processes were developed. Interview data regarding particularly helpful elements and ideas for improvement were organized into topic summaries (in comparison with fully developed themes). These topics summaries were used as a starting point to facilitate ranking and discussion in the subsequent co-design meetings. They will be presented when describing the results of the co-design meetings.

The purpose of the co-design meetings was to validate the developed themes related to treatment change processes (eg, regarding their meaningfulness) and reach a consensus regarding important ideas for intervention improvement and key treatment elements. Consensus was established in 6 independent co-design meetings (ie, the nominal group technique) held as 3 parallel meetings with patients and caregivers. This allowed us to establish consensus within groups (ie, consensus in 1 group) and between groups (ie, consensus in multiple groups) as an estimate of the representativeness of the opinions expressed. Patients and caregivers served as ad hoc consultants [15] and were compensated for their efforts (US $30 per hour). Their role was to validate the research findings of the previous thematic analysis and to provide feedback about the GET Living treatment from the receiver’s end [15]. The procedures were preregistered in the Open Science Framework [23]. The GRIPP2 (Guidance for Reporting Involvement of Patients and the Public) checklist for patient and public participation in research guided quality reporting of the study results [24].

Patients and caregivers who were randomized to the exposure treatment arm of the GET Living RCT (Stanford trial), including treatment completers and dropouts, were invited as research partners. Approximately one-third of the people invited accepted the invitation (10/33, 30% patients; 14/33, 42% caregivers). Research partners attended 1 of the 6 independent co-design meetings with parallel meetings for patients (meeting 1a: 4/10, 40%; meeting 2a: 3/10, 30%; meeting 3a: 3/10, 30%) and caregivers (meeting 1b: 4/14, 29%; meeting 2b: 5/14, 36%; meeting 3b: 5/14, 36%). All research partners were invited to a final wrap-up session (5/10, 50% patients and 8/14, 57% caregivers). More details on the research partners who attended the meetings are presented in Table 2.

The co-design meetings were scheduled for 2 subsequent calendar weeks (April 2022). The meetings were held via Zoom (Zoom Video Communications, Inc) and lasted approximately 120 minutes (including breaks). An optional web-based wrap-up meeting was held the following week (approximately 60 minutes). An overview of the procedure is provided in Multimedia Appendix 2. The meetings were moderated by CWH, LS, and LES.

Before the meeting, the research partners received a pre-engagement package with an outline of and the materials for the meeting. No preparation was required. At the beginning of the meeting, the research partners introduced themselves with ice-breaking tasks aimed at facilitating a good working atmosphere. Some ground rules were presented. Their role as research partners (as opposed to research participants) was highlighted.

The results of the thematic analysis of treatment change processes were then presented and discussed with the research partners to ensure that the identified themes were relevant and meaningful and to assess whether there were any important change processes missing from the established themes. The ideas for improvement collected during the semistructured exit interviews were then presented. The research partners were asked to rate the ideas using a Qualtrics (Qualtrics International Inc) survey. First, they were asked to select what they believed to be the 10 most important ideas out of the 48 ideas initially identified through the interviews. They were then asked to further refine their initial selection to identify the 3 most important ideas for improvement. The research partners were also encouraged to provide new ideas that were not found on the list as applicable. Once all the answers were collected, the results were shared with the group, and the research partners were asked to discuss the selections to ensure agreement among the retained items and address any differences of opinion regarding key recommendations. The same process was conducted to establish the most helpful out of 38 treatment elements that should be retained in future iterations of the intervention, and where applicable, the research partners were given intervention materials for review.

In the wrap-up meeting, action items from the co-design meetings were presented and finalized in a shared Word (Microsoft Corp) document. The research partners who could not attend the meeting were informed about the action items via email. They were asked to provide their written feedback within 2 weeks.

At the end of the meetings, all research partners completed module A of the Public and Patient Engagement Evaluation Tool [25]. Module A was developed to measure a 1-time engagement activity from a participant’s perspective. The module consists of 13 statements (eg, “I had a clear understanding of the purpose of the co-design meeting”), which the research partners were instructed to rate on a 5-point Likert scale (1=“strongly disagree,” 2=“disagree,” 3=“neither agree nor disagree,” 4=“agree,” and 5=“strongly agree”). The questionnaire also comprises 6 open-ended questions addressing key elements of quality public and participant engagement, including the integrity of design and process, influence and impact, participatory culture and collaboration, and common purpose. The questionnaire was used as a quality measurement of research partner engagement in the co-design meetings. In addition, we openly asked the research partners why they agreed to participate in the co-design meetings.

The first theme described how the patients and caregivers were better able to handle their pain-related emotions. Although the patients felt more confident in dealing with challenging situations, the caregivers had a space to process their own emotional struggles.

The patients learned through exposures that the experience was not as bad or challenging as they thought it would be. Overall, the patients described an emotional shift in their experience because it did not match their expected outcome:

Other patients and caregivers reported a change in their thinking:

There was a general shift in their perception of challenges. The patients also appeared to gain a sense of control:

Taken together, the patients realized that the situations they once feared were not as emotionally challenging or difficult as they expected them to be. On the basis of this experience, the patients seemed to see challenges as more approachable and manageable:

The caregivers became more aware of the overall experience of managing chronic pain and its impacts on the entire family:

The caregivers had room to express and process their own emotional struggles:

Some even expressed a newly found admiration toward their children:

Taken together, the overwhelming experience of living with chronic pain was felt by the entire family. The caregivers mostly expressed feeling anxious or sad for their child; however, they were able to shift their perception by reinterpreting this struggle as a strength. Instead of feeling sad or anxious, they expressed an admiration for their children for handling painful situations.

The second theme described how the patients and caregivers felt empowered during treatment. Whereas the patients experienced becoming more confident, the caregivers gave their children more space to handle difficult situations by themselves. Both felt that they learned concrete strategies for navigating difficult situations.

The patients’ experiences changed their perceptions of themselves. Many patients felt empowered and more confident. Some patients learned that they were capable of doing things despite their pain:

Other patients expressed a more generalized sense of being capable:

Taken together, the patients changed their self-perception and appeared to be more confident in their ability to handle difficult situations in the face of pain and other challenges.

The caregivers came to understand how to balance control and letting go. Some caregivers expressed that they could better see the benefits of giving their children more opportunities to handle their pain by themselves:

Other caregivers reported that they became more aware of the negative effects of being overly controlling:

Generally, the caregivers were able to hold back on responding with their initial reaction to better respond to the specific needs of their children:

Taken together, the caregivers were better able to control their initial reactions. After reflecting on the consequences of their own behavior, many caregivers said that they needed to relinquish some control to empower their children to manage challenging situations independently.

The patients and caregivers broadened their knowledge of concrete strategies to better cope and live with chronic pain:

The patients learned to break down activities in pursuit of long-term goals:

The caregivers felt that they had solid action plans to encourage activities:

Taken together, the patients and caregivers learned concrete strategies to navigate through difficult situations. These strategies helped reduce feelings of helplessness in both the patients and caregivers.

The third theme described how GET Living helped improve the relationship between patients and their caregivers. Being able to better understand the complexity of chronic pain, the caregivers were more able to validate their child’s experiences and felt closer to them. The patients also indicated that they felt more supported by their caregivers.

The caregivers better understood their child’s pain experience in their day-to-day difficulties:

The caregivers also understood the driving mechanisms of pain chronicity in more detail:

The caregivers also reported being better able to validate the experiences of their child:

Taken together, the caregivers became more aware of the difficulties of their children. They better understood the impact of chronic pain on pain-related disability and distress. The caregivers also became aware of the driving mechanisms of chronic pain, including emotional responses and misattributions. This allowed them to validate their child’s experience more.

The patients and caregivers reported that GET Living fostered improved family connections. The patients became more aware that they were not alone because they had their caregivers and families to support them:

The caregivers also felt a closer connection with their children:

Taken together, the relationships between the patients and their families improved. While the patients felt supported, the parents felt a closer connection with their children.

A total of 12 ideas for improvement were prioritized in multiple groups (ie, between-group consensus) and are presented in Table 3. The ideas were organized based on the degree of consensus between the groups. Five ideas that were prioritized by within-group consensus are presented in Multimedia Appendix 3.

Interestingly, these improvement ideas were not specific to exposure treatments and could be applied to any form of behavioral or physical pain treatment. For example, the research partners agreed that pain exposure treatment should be disseminated more. There was absolute consensus (consensus in 6/6, 100% co-design meetings) that pain exposure treatment should use patient testimonials to (1) provide patients with narratives of how other patients are dealing with similar difficulties, (2) inform future patients about what treatment will be like, (3) provide a role model, and (4) promote positive expectations. Most research partners also agreed that more efforts should be made to create awareness among the general public and primary care providers to facilitate an early referral for treatment (consensus in 4/6, 67% co-design meetings).

A total of 13 treatment elements were considered helpful in promoting change in multiple groups (between-group consensus; Table 4). For a clear overview, helpful treatment elements are organized by treatment phase. Seven treatment elements that were considered helpful by only the members of 1 group are presented in Multimedia Appendix 4 (within-group consensus).

In general, the research partners appreciated the understanding attitude of clinicians, personalization of treatment through the pursuit of individualized goals, education about chronic pain, encouragement of activities, and discussion of realistic expectations at discharge. For example, during the phase of goal setting, a majority of the research partners agreed that future exposure treatments should continue to empower patients to be “in charge” to choose meaningful exposure activities (consensus in 5/6, 83% co-design meetings), break long-term goals into smaller steps (consensus in 5 of the 6 co-design meetings, 83%), and help patients become aware of their own values and motivators (consensus in 2/6, 33% co-design meetings).

Overall, the co-design meetings were evaluated as good, with mean values being consistently at the upper end of the agreement scale (Tables 5 and 6). The research partners felt that the co-design meeting was a good use of their time, that they were able to contribute, and that they were confident that the meeting’s goals were achieved.

This study looked at a multidisciplinary exposure treatment for youths with chronic pain through the lens of patients and caregivers. First, qualitative analysis of exit interviews conducted with patients and caregivers after they received the GET Living intervention explored the treatment change processes. Second, co-design meetings with patients and caregivers as research partners aimed to refine the GET Living intervention. The implications of both aspects are discussed in the subsequent sections.

The qualitative analysis revealed a wide range of treatment change processes, indicating that what happens within patients during treatment is complex and difficult to describe from a single theoretical lens [19]. The patients and caregivers described that the exposure treatment helped them to (1) better process pain-related emotions, (2) feel empowered, and (3) improve their relationship with each other. The elements of these reported changes align with different theoretical models. In line with the inhibitory learning approach [26,27], the patients experienced a violation of their expectations, wherein feared situations were not as emotionally challenging or difficult as expected they them to be. By contrast, the caregivers reported a reduction in protective behavioral responses when they felt more in control of their emotional distress, which, in turn, empowered the patients to handle difficult situations themselves. This aligns with the theoretical assertions of the interpersonal fear–avoidance model [28,29]. In addition, the patients reported changes that are considered resources according to the resilience-risk model [30]. On an individual level, the patients reported improved self-esteem (“I am actually capable”). In terms of their family and social environment, they felt more supported (“I have a support system”). Consistent with the interpersonal process model of intimacy, the patients and caregivers experienced an increase in intimacy and improvement in their relationship when the caregivers were better able to understand and validate the patients’ pain experience [31]. Looking through the lens of self-determination theory [32], the treatment might have satisfied the need for autonomy and competence (eg, by having patients be “in charge,” which was ranked as a particularly helpful treatment element), which facilitated goal pursuit despite chronic pain and an increased a sense of confidence. The patients also felt more supported, indicating satisfaction in the need for relatedness. However, the patients wished to extend this support to their peers with chronic pain. Altogether, the present results underscore the need for a more holistic approach to understand the full complexity of treatment change processes within patients and in their interaction with their social environment. Future research using and combining contemporary quantitative methods (eg, ambulatory assessments, network analyses, and SCEDs) could use the present findings to flexibly and rigorously study treatment change processes from idiographic and nomothetic perspectives [33].

The research partners prioritized 13 core treatment elements that were helpful in promoting change. This feedback can directly inform clinicians which specific behaviors and techniques are perceived as impactful. This is informative for clinicians in general but especially in settings with time constraints. For example, a majority of the research partners agreed that future exposure treatments should continue to assist patients in finding and pursuing meaningful goals. This recommendation agreed with pain scientists, who advise combining exposure treatment with clarification interventions to identify personal goals and goal conflicts [34]. Such techniques could also have the potential to ameliorate other behavioral programs. However, future research should systematically investigate the benefits of these techniques (eg, improving outcomes or facilitating the transfer of skills to daily life).

The research partners also agreed upon 12 ideas for improvement. At their core, these ideas suggest that pain treatments should be disseminated more, flexible, and transparent. The research partners advised that there should be a platform for exchange between people with lived experiences and that the complexity of the individual pain experience should be acknowledged. To our surprise, most ideas were not specific to the content and refinement of exposure treatment; instead, they could inform the implementation of behavioral or physical pain treatments more broadly.

The research partners conveyed that increasing the access to and dissemination of pain psychology treatment is of upmost importance, a message also building momentum among pain scientists [35]. At the receiver’s end, the research partners recommended to better clarify the role of psychological interventions in the context of a multidisciplinary pain treatment approach. Thereby, they came up with creative ideas such as video testimonials or advertising campaigns to clarify treatment aims and promote positive expectations. At the same time, the research partners also suggested better acquainting other treatment providers with this treatment option to facilitate early referral. In addition, they considered an increase in flexibility (eg, in terms of session duration, frequency, content, and delivery format depending on momentary pain level) a promising step toward improvement. Although shifting plans based on pain levels stands in contrast to pain scientists advocating that time and quota–contingent treatment plans are preferred over pain-contingent plans [36], it introduces an important consideration for pragmatic implementation in real life. Momentarily scaling back an activity versus rigid adherence to a plan could ultimately provide the flexibility needed to reach the long-term goal of greater life engagement and functionality.

The research partners considered the remote delivery format with optional in-person check-ins (eg, to build trust) as promising beyond the pandemic, which aligns with initiatives underway in the pain treatment field, as the pandemic has accelerated the dissemination of remotely delivered pain management services [37]. Continuing this path might contribute to a greater dissemination of pain psychology treatments, especially among youths. Remotely delivered treatments might also be beneficial for other behavioral or physical treatments (eg, to facilitate integration into daily life). Moreover, the research partners wanted more support in transferring and maintaining learned strategies (eg, via booster sessions). This request suggests potential ways to address the issue that the effects of pain psychology treatments are often not stable over time [3]. Altogether, the research partners created an abundant set of ideas focused on improving the delivery of pain treatments. From a human-centered design perspective, the present results specify the needs of patients and caregivers [38]. Future research could use these ideas to investigate whether tailoring implementation strategies to end users’ needs relates to better behavioral (eg, penetration) and perceptual (eg, acceptability) implementation outcomes [39]. For example, it would be interesting to see whether tailoring implementation strategies for pain treatments results in fewer people declining to participate and fewer dropouts.