Computer-based interventions (CBIs) can be effective alternatives or complements to face-to-face delivery in psychological treatment and chronic illness management [1-4]. However, systematic reviews on effectiveness of CBIs have concluded that sizable and heterogeneous proportions of patients stop using CBIs before completion [5-7]. Nonusage attrition in CBI studies depends on factors such as therapist involvement, demographics, computer self-efficacy, and health status [6-11]. As a strategy to improve patient engagement, some CBI designs have incorporated interactive features [12,13]. Interactive and visual-enriched designs may support patient demand through perceived personal relevance, social support, and enjoyment [14,15]. Accordingly, computer game technology has been applied to engage people and to promote health behaviors and clinical outcomes [16,17].

Chronic pain and fatigue complaints constitute a major burden for individuals and societies worldwide [18-20]. Functional somatic syndromes (FSS) are diagnosed by medical specialists when bodily functioning is disturbed, somatic symptoms persist longer than a normal healing process, and conditions cannot be fully attributed to a known conventional disease [21]. A high degree of commonality exists between FSS, wherein central sensitization may be a biological substantiation [22]. FSS can be precipitated by profound life events and cultural factors and maintained by psychosocial factors [20]. Evidence supports the effectiveness of various cognitive and behavioral interventions in primary care settings, or within interdisciplinary rehabilitation programs (IRPs), when “unimodal” psychiatric or physiotherapeutic services do not suffice [20]. Nonetheless, patients were often seen by their general practitioners, but seldom accessed specialized behavioral or multi-modal treatment, and often believed that their complaints are inadequately managed (28%-62%) [17].

Efficient use of scarce resources and removal of access barriers are important motives for developing CBIs [2]. Results on the effectiveness of computer-based behavioral interventions are promising, but uncertainties regarding their actual usage certainly applies to FSS patients [2,23]. Virtual reality and gaming technologies have been applied for triggering positive emotions, distraction, or graded exposure in rehabilitation and pain management for improvements in physical functioning, pain symptoms, and daily life activities [24,25]. However, there has been no evaluation of the effectiveness of applied gaming as an independently accessible means for delivering behavioral change messages to patients with FSS [16,17,26]. The actual extent and reasons of patient engagement in applied games will largely determine their effect [16]. A better understanding is needed of why CBIs have not been optimally used by which patients with chronic pain and fatigue symptoms to overcome the treatment barriers they face and why integration of applied gaming can offer a partial solution [2,17-19].

This study aims to explain the usage of applied gaming and provide a comprehensive feasibility description from the perspective of adult patients with chronic pain and fatigue complaints. The opportunity to conduct this study was provided by the planned incorporation of the applied game “LAKA” within a standardized IRP for adult patients with chronic and complex fatigue or pain symptoms in the Netherlands. The primary objective is to explain variation in the demand for applied gaming when offered for voluntary usage during an IRP. Relationships are studied between usage (intentions), behavioral factors, and patient baseline characteristics, including case mix, functional and clinical status, and medical history. In doing so, this study contributes to a better understanding of why applied games are demanded by patients in real health care settings. Second, feasibility was thoroughly described to prepare for a full-scale evaluation in exploring the domains of acceptability, implementation, practicality, and promise for efficacy. Both research goals are reflected in a conceptual framework (see Multimedia Appendix 1) integrating technology acceptance modeling in a feasibility study design [23-27]. Overall, this contribution enables feasible proposals for incorporating and evaluating an applied game for behavioral change within the rehabilitation of patients with complex chronic pain and fatigue complaints.

A mixed-methods design was implemented with sequential quantitative (QN) and qualitative (QL) phases [28] (Figure 1). Owing to the availability of adequate quantitative research instruments, an explanatory sequential mixed-methods design worked well for triangulation, illustration, and complementing QN findings with in-depth QL insights and with practically useful information about feasibility [29,30]. The QN phase was prioritized and set up as a longitudinal single-group study of target patient responses to LAKA when offered for voluntary usage during the first 8 weeks of their IRP. The QL phase provided a complementary inductive approach to both research questions. QN and QL phases were mixed in using QN results for the preparation of QL data collection and again when integrating and documenting QN and QL results.

Ethical approval for the protocol was obtained for this study (at the Psychological Ethical Testing Committee of Tilburg School of Behavioral Sciences, Tilburg University). In total, 410 patients were eligible to start an IRP in 1 of 4 facilities of Ciran, a Dutch rehabilitation center, between 6 January, 2014, and 6 April, 2014 (criteria are listed in Textbox 1) and had given permission to process their diagnostic records for scientific research. Patients in this group were prompted on the day of their first appointment with an email invitation containing information about the nature and consequences of participation in the study, and a link to the “serious gaming page” (see Multimedia Appendix 2). This page guided patients through procedures for software access and additional data collection. Local team leaders were requested to organize face-to-face reminders for patients about the study and the accessibility of LAKA regardless of giving informed consent.

Additional QN data were collected from study participants with two surveys and log-file recordings. The first survey was to be completed within 4 weeks after the invitation and before usage (t1). The second survey (t2) was added to a standard midterm evaluation after 8 IRP weeks, and was to be submitted by the 12th week. Participants’ actual usage behavior had been logged automatically between the pre and post surveys. In the intermediate phase, the focus was on "demand" as the primary subject of the study. Two extreme cases were selected so that a relationship between the most predictive baseline characteristic for the use of LAKA could be clearly illustrated. Two more cases were selected with demand levels that were poorly explained by this “key” predictor and more likely to provide information about omitted factors or counterfactuals. QN results were also used to set up an interview schedule. Purposefully selected participants were invited with a prescripted telephone call after their IRP was finished. Interviews were held during 1- to 1.5-hour home visits and were tape-recorded and transcribed. Field notes were taken, and full transcripts were sent to respondents by email within a week after the interview.

A standardized 16-week IRP was delivered by teams of physiotherapists, psychologists, spiritual counselors, and medical rehabilitation specialists (Textbox 2). A full description of the IRP is provided by Garschagen et al [31].

As recommended, functional requirements were specified before the modeling and evaluation of LAKA [34]. LAKA delivers skills training with metaphorical simulation elements (encounters) and guided exercises for focused attention and open awareness [35]. These elements are interspersed with images of real-world environments, immersive mini-games, and in-game debriefings for “transferring” new insights beyond the virtual world (Textbox 3). Basic information on functional specifications and playability feedback are described and illustrated with screenshots and trailers in Multimedia Appendix 3. A Windows version of LAKA was offered for usage wherever and whenever convenient, without support from health professionals. No recommendation for a minimum or maximum amount of usage was given, and no prompts or reminders were sent. On the one hand, it was expected that many target patients would not use LAKA because of this noncommittal mode of delivery. On the other hand, this variation was desired to discover explanations and practical suggestions that generally apply for delivery in open and clinical settings.

Of the 410 invited eligible patients, 32.2% provided informed consent and completed the first additional survey (Figure 2). The 84 patients who reported why they did not wish to participate mentioned “other obligations” (23), “facilitative problems” (14), “no intention to use the intervention” (14), “not enough energy or concentration” (13), “no interest to participate in the research” (10), “bodily complaints” (8), or “other reasons” (2). One patient withdrew because of a broken computer, and one for experiencing excessive hindrance in attempting to use an unsupported Web browser. The second questionnaire was submitted by 93 participants (80.2%).

Study participants’ average age was 44.4 years (SD 10.8 years; range 21-63 years); 71% were female (Table 1). Sixty-nine participants were completely absent from work. The average duration of absenteeism was 157 days (SD 223.0), with a median slightly more than 100 days. Forty-seven participants (40.5%) reported moderate to severe pain (5-10), and 108 experienced problematic fatigue. Average scores for depressive (42.9, SD 11.4) and anxious (22.2, SD 8.2) symptoms were high. Participants had been regularly surfing the Internet, but only 46 patients (39.7%) had been playing on a computer over the past year. No statistically significant differences between participants and nonparticipants were found for case-mix variables. However, patients with more severe pain symptoms were underrepresented in the sample (Table 2). The group of 71 patients who actually logged in (players) reported relatively higher scores for coping through active engagement and social support seeking, lower scores for pain coping, and fewer environmental issues. The proportion of patients who had received specialist treatment for their current complaint was lower among players than among nonplayers (χ² ₁=4.1; P=.042; not in Table 2).

Four interview respondents were selected based on their combination of scores for coping by active engagement and demand (Table 3). Open questions were asked to introduce and focus on topics (see Multimedia Appendix 6). Two topics addressed the primary research question, namely, “initial response” to the digital game offering (topic 1) and patient “experiences” throughout their interactions with LAKA (topic 2). Topic 2 and “suggestions for improvement” (topic 3), served to collect complementary information on feasibility domains. After a first round of mixing, 4 interviews was deemed sufficient to provide clear illustrations of the most notable QN explanations for demand.

Respondents suggested to integrate LAKA, similar to other program elements patients normally adhere to. Additional support was desired by means of a personalized introduction early in the program, information about how to get something out of the game and about what is achieved afterward, professional feedback on situations in the game, and facilities for gaming at Ciran locations. Suggestions for playability were to match the pace of in-game interaction with skill or health status and to extend software support to multiple platforms.

This study primarily questioned why and by which patients with chronic pain and fatigue complaints is applied gaming for behavior change demanded during an IRP. Voluntary applied gaming (LAKA) was generally explained over time by perceived enjoyment and ease. Coping resources are important to solve delivery issues, get in control, and start using an applied game. Patient environment, health status, and performance expectancies were relevant factors for the usage of an applied game in conjunction with time and exposure.

Second, feasibility was described in preparation for a full-scale evaluation. A substantial number of patients played the game under noncommittal conditions. According to them, LAKA will be acceptable and useful. Active ingredients were recognized and deemed to be relevant in early stages of a rehabilitation process. Patients suggested delivering the game with social support through early and expeditious communication about how and when the game is relevant for their rehabilitation and with extended technical facilities.

This study provides the first empirical results on a novel applied game for behavioral change in patients with chronic pain and fatigue complaints. Comprehensive information is presented on processes of self-selection, acceptance, and attrition, which provides rare insights into risk factors for bias in CBI evaluations [58]. Mixed methodology strategy worked well to triangulate QN findings with newly collected QL data. Important demand explanations are based on notable and robust statistical results supported by a decent sample size and clear illustrations with QL data. QN results that were not clearly illustrated with QL data, or were based on more selective patient samples, provided practical information and clues for future research. More than a final feasibility assessment, this study contributed with general and utilizable knowledge for the future deployment of applied gaming for FSS patients in practice.

Limitations should be considered when drawing general conclusions about the feasibility of applied gaming for FSS patients. Feasibility was not assessed against a control group level or a reasonable benchmark. Technology acceptance measures are commonly used, but they are often contextually adapted and serve in theory building rather than feasibility assessment. Furthermore, this study builds on pragmatic eligibility criteria and convenience sampling of Dutch patients. It cannot be ruled out that early judgments about the nature of the delivery mode affected results via self-selection. Performing a large number of explorative statistical tests threatens statistical power and internal validity. Caution should be exercised when interpreting causality in relationships between behavioral factors and behavioral intentions because independent and dependent variables were measured at the same point in time, and hedonic motivation was not clearly distinct from performance expectancies and behavioral intentions. Whether the use of technology acceptance questionnaires alone would be an appropriate method for assessing the usage of gaming technology, especially at a time when patients may have difficulty processing information, can be doubted and is not recommended. Finally, advanced statistical techniques such as partial least squares regression [59] or newer process analyses techniques [60] would have been appropriate, but were not used. QN method limitations were addressed by triangulation of key QN findings with QL data, comprehensive sample description, validity checks, residual analysis, and sensitivity analyses (for outlier removal, measures of association, and regression method; see Multimedia Appendix 7).

Researchers have stressed that a better understanding of the demand for CBIs is a major concern in overcoming barriers to treatment of patients with chronic pain and fatigue symptoms [2,3]. To our knowledge, this is the first empirical study on applied gaming for the delivery of behavioral intervention for patients with chronic somatic symptoms and functional problems. Findings suggest that voluntary engagement in applied gaming is strongly driven by positive affect. The importance of hedonic motivation for demand is remarkable because this is an often-omitted factor in previous research on the use of information technology in health care [27]. Concerns about utility, demonstrability of results, privacy, or consultation seemed to have a limited effect on demand in this case, when patients had no previous experiences. Ubiquitous interview quotes about “openness” hinted that inclinations to search for meaning or personal growth could partially explain demand for applied gaming [61,62]. Concluding that FSS patients will use an applied game “for the sake of the activity itself” is tentative. Applied gaming interventions are relatively new and barely institutionalized, and limited information was available to patients about the efficacy of LAKA or a similar game. It could also be that patients thought about usefulness and trustworthiness of care before deciding on following an IRP. Moreover, findings on influences of individual differences in coping styles and perceptions of control and ease on the usage of LAKA correspond with those of earlier studies that found a positive effect of internal locus of control on the adherence to a web-based positive psychology intervention [9]. Such results might also reflect differences in executive functioning or capacities for self-control [63].

Other remarkable QN results, which were not clearly illustrated with QL data, are discussed in connection with past research or as areas of future research. Findings on the effect of depressed mood on CBI usage have been heterogeneous [30]. This study pointed in the direction of a negative relationship, but found no statistically significant direct effect. This might be because of the comparatively high levels of psychopathologic symptoms of these FSS patients [64]. A moderation effect is indicated by extremely low BIs that were found exclusively in patients with low to neutral performance expectancies and high levels of depressive symptoms. Furthermore, computer anxiety and experience might explain differences in relationships between age and technology usage found in earlier studies [27]. Moreover, patients with lower scores for pain intensity and those who indicated fatigue as their primary complaint were more likely to self-select as a player, whereas patients with higher pain intensity played more once exposed. Further research on the usage of CBIs could focus on understanding “matches” between symptom characteristics, “readiness,” and demanded delivery mode of behavioral treatment for FSS populations [65]. Another research focus can be patient-environment interactions (ie, coping with issues at home, absenteeism, and return to work) as barriers and facilitators for demand within this target group. For informing design and implementation of computer- and game-based modalities, it is useful to proceed with qualitative research and by formulating and testing theoretically informed hypotheses on how usage varies by patient, program design, behavioral, and context factors [26,61,66-68].

The degree of implementation of LAKA for eligible patients is not satisfactory, as could be expected when a CBI is offered under ad libitum conditions [69]. Besides blending with face-to-face delivery and multiplatform distribution, solutions for additional support can be provided through Web-based features such as tailored messages, prompts, and support via email, chat, or message boards [4]. Acceptability and limited efficacy outcomes should be treated with caution but suggest that LAKA is potentially efficacious and sufficiently engaging to complete once or twice (2-4 hours). Moderately positive enjoyment by users may reflect that the design principle of LAKA was not entirely hedonic, maybe at the expense of “playability” aspects [70]. Eliciting reflective and meditative states, LAKA was pleasant for a patient with concentration problems; however, self-reflections seem to be at the expense of a more satisfactory speed of interaction. Moreover, the game appears to provide opportunity to realize ideal selves, which supports intrinsic motivation [57]. However, LAKA also triggered serious reflections about discrepancy with “actual” selves, which is associated with somatic symptoms and negative emotions [71]. “Slowness” was mentioned as a reason for disengagement, but self-awareness was not. One may also reflect about how self-awareness in virtual reality relates to bodily and behavioral representations of Avatars [72] because extremely low perceived knowledge improvement levels were exclusively reported by patients with high BMI levels at baseline. High-quality and adequately powered studies on the effects of LAKA and similar systems on functional domains are needed to clarify the roles of self-conscious and affective states, learning, and degree of engagement [16,17,73].

Although these first empirical findings support that an applied game is used by FSS patients for enjoyment and convenience, it became very clear that many patients would not be reached with a behavioral intervention of this modality under voluntary conditions. Social factors remain highly important for reaching many patients. LAKA will be feasible as a short and early intervention for patients, with adjustments of social and technical support. A next step in deployment and evaluation of the efficacy and cost-effectiveness of LAKA in a controlled study is recommendable.