Abstract
Chronic pain and heavy drinking are common comorbid conditions among people living with HIV/AIDS (PLWHA). An integrated approach to address these co-occurring conditions in a manner that facilitates treatment utilization would represent an important advance in HIV-care. This study examined the acceptability and feasibility of a tailored, videoconferencing intervention to reduce chronic pain and heavy drinking among PLWHA. Participants in HIV-care (n = 8) completed baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions. Acceptability and feasibility were assessed with patient satisfaction ratings and interview responses 8 weeks following baseline along with videoconferencing use during the intervention period. Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format. All participants successfully enabled videoconferencing on their own smartphones and completed a median number of 4.5 (out of 6) video-sessions. Changes in heavy drinking and pain provided additional support for the potential utility of this approach. Results suggest that this videoconferencing intervention is an acceptable and feasible method of addressing chronic pain and heavy drinking among PLWHA. Findings provide the basis for future work to examine the efficacy of this approach in a Stage 1b trial.
Keywords: HIV, chronic pain, alcohol, heavy drinking, self-management
Introduction
People living with HIV/AIDS (PLWHA) experience high rates of chronic pain, which exceed 50% in some HIV-clinic cohorts (Merlin et al., 2015; Uebelacker et al., 2015). Pain among PLWHA has direct effects on HIV-related symptoms and indirect, deleterious effects on HIV outcomes through non-adherence to HIV-care recommendations in some populations (Merlin et al., 2012). Among the challenges of addressing chronic pain among PLWHA is the fact that patients often have comorbidities that influence the development and course of both pain and HIV. One of the more important of these is heavy drinking. Heavy drinking has been shown to influence HIV medication adherence (Golin et al., 2002; Samet, Horton, Meli, Freedberge, & Palepu, 2004), immune system efficiency (Wang, Gao, Zakhari, & Nagy, 2012), disease progression (Baum et al., 2010), depression and anxiety (Sullivan et al., 2008), and sensitization to pain (Apkarian et al., 2013). Behavioral interventions have been shown to be effective for pain management (Department of Health and Human Services UG) but there have been few efforts to tailor approaches to the unique needs and characteristics of HIV-populations (see Merlin et al., 2017 for an exception). Moreover, specific intervention strategies have not yet been developed to address both chronic pain and heavy drinking among PLWHA despite the high rates of both in this population and the identified importance of tailoring pain management interventions to the unique needs of patients (Merlin et al., 2018).
Even with the potential advantages of an integrated intervention, a central challenge for treating pain and alcohol use among PLWHA is engagement and retention in care. PLWHA who experience pain and heavy drinking face a number of barriers to attending clinic visits for in-person treatment including transportation, child/elderly care, and a significant physical symptom burden from HIV and co-morbid conditions (Yehia et al., 2015). Substance use disorder and pain management treatment drop-out rates, which are high in the general population, tend to be particularly high among PLWHA, who face unique challenges associated with stigma and the priorities of addressing other health-related conditions (Durvasula & Miller, 2014). Providing alternative intervention modalities that do not require repeated in-person medical visits is critical for reducing patient burden, increasing access to care, and ultimately improving the efficacy of intervention approaches. Internet-based videoconferencing provides an important alternative modality to improve intervention dissemination and facilitate treatment adherence (Comer et al., 2015), particularly among populations that face significant barriers to in-person treatment (Anton et al., 2016; Comer et al., 2015; Myers & Comer, 2016). Internet-based video telehealth can provide the interventionist with direct information on how patients are understanding and executing the skills and the smartphone app or web-based platform allows interventionists to introduce more extensive technology enhancements to treatment (Anton et al., 2016; Jones et al., 2015). Finally, previous work has shown that video telehealth interventions are equivalent to in-person sessions in terms of patient satisfaction with treatment (e.g., Frueh, Henderson, & Myrick, 2005; King et al., 2009).
The purpose of this study was to develop a tailored videoconferencing intervention to reduce heavy drinking and chronic pain among PLWHA through a proof-of-concept open pilot trial. Consistent with recommendations for behavioral treatment development (Czaijkowski et al., 2015; Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), we conducted an initial open pilot trial to provide preliminary information about (1) the acceptability of the intervention to participants; (2) the feasibility of delivering the intervention though an app-based videoconferencing platform and completing research procedures in preparation for a Stage 1b pilot randomized controlled trial. This study also sought to use implementation experiences to identify potential barriers and facilitators of intervention adherence to plan for a pilot efficacy trial.
Methods
Participants
Patients were eligible if they were 18 years of age or older, fluent in English, engaged in HIV-care, reported at least three months of chronic non-cancer related pain that was moderate or greater in intensity on average over the past week, and reported heavy drinking in the past month (based on the National Institute of Alcohol Abuse and Alcoholism definitions of exceeding weekly or single day drinking limits). Patients currently using pharmacological approaches to manage pain or alcohol use were eligible if medication doses were stable (i.e., same prescribed dose for at least two months). Patients with a history of bipolar disorder, schizophrenia, or complicated alcohol withdrawal, those in current psychosocial treatment for pain or alcohol use, and those with an anticipated surgery in the next six months were excluded.
Recruitment
Participants were recruited from two settings; (1) an ongoing cohort study of patients in HIV-care with a past history of drug or alcohol dependence, the Boston Alcohol Research Collaborative on HIV/AIDS Cohort (Boston ARCH Cohort) (see Saitz et al., 2018), and (2) an infectious diseases clinic at a large, urban academic hospital through advertisements posted in the clinic. Participants were screened to determine study eligibility in-person or by telephone.
Assessments
Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is an 8-item measure of perceived value of treatment services that has been established as a valid and reliable measure across a range of conditions, interventions, and populations (Kelly et al., 2017; Larsen, Attkisson, Hargreaves, & Nguyen, 1979). Items range from 1 “poor” to 4 “excellent” with the total score range from 8 to 32, with higher scores indicating higher treatment satisfaction.
Perceptions of Treatment Questionnaire (PTQ-17)
The PTQ is a 17-item questionnaire used in previous treatment development studies (Pincus, May, Whitton, Mattis, & Barlow, 2010) that provides descriptive information about perceived comprehensibility and utility of the intervention using 0 “not-at-all” to 8 “very much” Likert-type scales. This measure also includes a series of open-ended questions regarding perceived benefits and limitations of treatment (i.e., what was most helpful, what was the most important thing learned, what was least helpful, what would you change about the treatment).
Pain Outcomes
The Brief Pain Inventory-Short Form (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function using 0–10 scales. The time-frame used in this study assessed pain “in the past 7-days.” The BPI has excellent reliability and validity which has been widely established in research with medical populations (Kiluk, Dreifuss, Weiss, Morgenstern, & Carroll, 2013). Main outcomes were the average pain severity rating item and the average score from pain interference items (Dworkin et al., 2005).
Alcohol Outcomes
Heavy drinking was identified by screening based on NIAAA criteria of either exceeding gender specific typical standard drinks per week (women > 7, men > 14) or frequency of heavy drinking episodes (women > 3 per occasion, men > 4 per occasion) in the past 30-days. The median number of drinks per week and the median number of heavy episodic drinking days in the past month were assessed using the 30-day alcohol Timeline Followback calendar method (Alcohol TLFB-30) (Sobell, Maisto, Sobell, & Cooper, 1979).
Additional Assessments
Participants completed a series of assessments to characterize demographic characteristics, smoking and other substance use characteristics (Rosen, Henson, Finney, & Moos, 2000; Turk et al., 2003), and health behavior change processes related to pain and alcohol use (Breslin, Sobell, Sobell, & Agrawal, 2000; Budd & Rollnick, 1996; Karoly & Ruehlman, 1995) to test feasibility of using these assessments with the population within the schedule of interview visits.
Measures were administered at both baseline and follow-up assessments with the exception of the CSQ-8 and PTQ-17 which were administered during the post-intervention assessment only.
Intervention
The initial intervention manual was developed based on previous work on cognitive-behavioral and self-management treatment for pain (Merlin et al., 2017; Otis, 2007; Uebelacker et al., 2016), and self-management for alcohol use (Morgenstern et al., 2007; M.B. Sobell & Sobell, 1993). It was then tailored to the needs of the HIV-care population as determined in an analysis of themes derived from a series of qualitative patient interviews (Palfai et al., 2019). The first intervention component was delivered in person following the assessment and was designed to help the patient understand how various lifestyle factors such as heavy drinking influence the experience of pain and HIV symptoms and set expectations and goals for the intervention. This initial session also sought to have the participant consider the role of alcohol in his or her life and foster readiness to change through the use of motivational interviewing strategies (Miller & Rollnick, 2013). The subsequent behavioral intervention components relevant to both pain and heavy drinking were provided through videoconferencing in the following order; (1) behavioral activation, (2) triggers, self-monitoring and relaxation strategies, (3) stress, automatic thoughts, cognitive restructuring, (4) planning: activity pacing and harm reduction skills for drinking, (5) sleep: associations with pain and heavy drinking, ways to improve sleep hygiene, (6) reviewing skills and continuing self-management beyond treatment. The intervention was delivered through a HIPAA-compliant software system that provided the capacity to send the patient additional materials (e.g., homework sheets, video demonstrations).
Procedures
Participants were screened by phone or in-person (for those recruited from the Boston ARCH cohort). Eligible participants were scheduled to complete the initial visit that consisted of consent procedures, a 50-minute baseline assessment, followed by a 45-minute in-person session with a licensed clinical psychologist (TP). Prior to leaving the initial session, participants learned the procedures for the subsequent video-conferencing intervention (e.g., using the app, etc.) and practiced using their own smartphones. Participants who did not own a smartphone with a functioning camera or with adequate data coverage were given the option of using a study phone for the duration of the intervention. They were scheduled to complete the first videoconferencing session within a week of the baseline interview. Patients were typically scheduled for their first videoconferencing session at the end of the baseline visit, though some requested a subsequent phone call to have time to identify availability in their schedules. Subsequent sessions were scheduled for each week by either the research assistant or interventionist and depended on the participant and interventionist availability.
Participants were reminded via text message the day before and the day of the intervention. Five minutes prior to the appointment time, they were sent a link for the videoconferencing session either by text or via email. Those who experienced any difficulties using the technology were able to consult a “troubleshooting” form or call the study assistant to guide them through the videoconferencing procedures. Videoconferencing sessions were scheduled for up to 45 minutes and ranged from 20–45 minutes. Each videoconferencing session began with a review of symptoms and skills from the previous week followed by the topic for the current week. In addition to the live session with the interventionist, participants were also sent brief (2-minute) video demonstrations for some of the skills that they learned and worksheets to remind them of content and homework. Participants were permitted to reschedule up to 3 sessions; more than 3 sessions counted as missed appointments. The post-intervention assessment was conducted in person by a research assistant approximately 8 weeks after the baseline interview. Participants were provided compensation for in-person assessments at baseline and follow-up but not for attending the videoconferencing sessions.
Results
Participant Flow through the Study
From the Boston ARCH Cohort, 29 participants were approached for screening, 20 completed screening, 5 were eligible, and 5 were enrolled. From the clinic sample, 10 participants were screened, 5 were eligible, and 3 were enrolled in the study. Seven of the eight patients completed follow-up procedures at 8-weeks.
Sample Characteristics
The mean age was 53.3 (SD = 8.8). Seven participants identified as male and six identified race as Black/African American, while two identified as White. One participant identified ethnicity as Hispanic. At baseline, the mean pain severity rating was 7.3 (SD = 2.1, range 4.0 – 10.0) and participants reported a mean of 8.0 (SD = 7.2) heavy drinking episodes in the past month.
Intervention Acceptability
Intervention Evaluation Ratings
The global ratings from the Client Satisfaction Questionnaire-8 were high (M = 29.29, SD = 2.29. median = 29.50) indicating that patients experienced a high degree of satisfaction with the intervention. Ratings of items from the Perceptions of Treatment Questionnaire (items rated from 0 = “not at all”, 8 = “very much”) further supported the acceptability of the intervention as patients reported that they found it “made sense in terms of managing symptoms” (M = 6.86, SD = 1.57, median = 8), “helped them cope with their symptoms” (M = 6.86, SD = 1.68, median = 8), and reported that they “would be confident recommending it to a friend” (M = 7.86, SD = 0.38, median = 8).
Post Intervention Responses
Patient responses to open-ended questions of the PTQ-17 provided further insight into their experiences of the intervention. Participants primarily remarked on content (e.g., “that I got to think about alcohol”, “how to manage”, “how to meditate on my pain”) and the interaction with the interventionist (e.g., “more support towards the person”, “that he cared about my pain” “he gave me advice on what to do”) as benefits of the intervention. “The immediacy of the interaction” was identified as an advantage of the videoconferencing format. Indeed, one participant remarked that he felt more comfortable discussing his feelings/experiences in his own home through videoconferencing compared to a clinic office. However, the two patients that did identify areas to improve both mentioned technical difficulties with the videoconferencing. One of these patients expressed appreciation for the availability of a study phone provided after difficulties with videoconferencing connection during the initial sessions.
Symptom Outcomes: Pain and Heavy Drinking
Participants reported a mean decrease of 1.71 points (SD = 1.75) (median decrease = 2.43) on the pain-related interference scale and 1.57 (SD = 1.51) (median decrease = 2.0) points on the pain severity scale. Regarding alcohol use, participants showed a mean decrease of 8.14 drinks per week (SD = 12.30) (median decrease = 15) and a mean decrease of 2.86 heavy drinking episodes over the past month (SD = 3.62) (median decrease = 4). Notably, while all of the participants met NIAAA-defined criteria for heavy drinking at baseline, four of them no longer met these criteria at follow-up. 1
Number of Intervention Sessions Attended
All patients completed the in-person session which immediately followed the baseline assessment. The mean number of video-conferencing sessions attended was 3.63 (2.67) with a median of 4.5 out of 6 possible sessions.
Optimization Information
We used implementation experiences to provide information about ways to optimize acceptability and feasibility in subsequent work. Although participants all had their own smartphones, some experienced challenges with the camera quality and the quality of their internet connections due to data plans from less widely distributed carriers and/or poor Wi-Fi connectivity. This prompted the decision to provide a study phone for one participant who exhibited no subsequent difficulty. Most participants used the videoconferencing system without the need for technology support, although there was one who required assistance on a more regular basis to get connected before session. The availability of ongoing technological support for patients, though rarely used, appears to be an important feature for ongoing work. Finally, appointment reminders also proved to be critical. Text-based reminders both the day before and the day of the session were important, even in the hour before the session, for enhanced engagement. Assessment and patient screening, enrollment, and follow-up procedures were implemented without difficulty as patients were able to comprehend all questions and complete measures within the scheduled visit time.
Discussion
Co-occurring chronic pain and heavy drinking is common among PLWHA, however, to our knowledge, no intervention has been developed to address both of these conditions together in this population. The current study sought to provide initial acceptability and feasibility information regarding the delivery of a tailored, videoconferencing-based integrated intervention that addressed pain and alcohol use in a proof-of-concept study. Overall, ratings of participant satisfaction and comprehension suggest that this approach is acceptable to patients. These ratings were paralleled by responses to open-ended questions as they found this intervention useful and easy to understand. The importance of the therapeutic alliance for the intervention was consistent with themes that emerged from a previous qualitative study with this population (Palfai et al., 2019) which highlighted the importance of perceived acceptance and concern from providers as part of desired health care interactions. Patient satisfaction with the intervention was complemented by heavy drinking and chronic pain symptom ratings post intervention.
Study results provide preliminary support for the acceptability and feasibility of this intervention, and the research procedures used. However, the study was not without challenges. Although participants all had their own smartphones, some had difficulty with video connectivity due to poor phone quality and/or data plans. There are clearly a number of benefits for using patient’s personal phones including ease of use, familiarity with functions, and greater likelihood of maintaining possession. However, these should be balanced in future work with the desire to ensure uninterrupted service by using study or clinic-provided phones. A second challenge was attendance. Given that there was no compensation provided for session completion, attendance rates were reasonable. Participants exhibited a relatively high degree of adherence to video sessions. However, frequent text messaging reminders were required to achieve observed rates of session attendance. Although the intervention procedures included more frequent reminders than may be used in standard practice, patients responded to these reminders favorably and expressed appreciation for this feature of the approach. Additionally, this feature could be readily programmable and automated for use in larger trials or in clinic settings. Although the study interventionist reviewed the use of these materials during weekly sessions, data on participant engagement beyond session attendance, such as time spent watching video demonstrations or completion of worksheets, was not collected. Future work should include data specific to engagement with adjunct intervention materials in order to optimize intervention features.
The study has limitations that must be considered. First, one cannot draw conclusions about the efficacy of this approach from a single arm study with a brief follow-up period. The small sample for this proof-of-concept study was not designed to test intervention efficacy but rather provide information about acceptability and feasibility relevant to testing this approach in subsequent work. Second, given the single intervention arm, the assessor was not blind to condition which may have increase demand characteristics of the interview. Third, no biological markers were used to confirm reports of decreased alcohol use. Future work should consider the use of PEth (Aradottir, Asanovska, Gjerss, Hansson, & Alling, 2006; Hahn et al., 2012) or hair sampling (Ledgerwood, Goldberger, Risk, Lewis, & Price, 2008) to augment self-reports of alcohol use outcomes (Hahn et al., 2016). Finally, the study only considered post-intervention outcomes so it is not clear whether the intervention had any effects that endured subsequent to the intervention itself. Longer-term outcomes will be assessed in future work to determine whether this intervention approach has a sustained impact on chronic pain and heavy drinking. In addition, future work may include specific features to help patients with potential relapse including providing patients with ongoing access to materials and making them aware of pain and alcohol use management resources.
Despite these limitations, study findings suggest that the current intervention holds promise as an approach to address the elevated rates of chronic pain and heavy drinking among PLWHA in a manner that can reduce patient burden and enhance engagement. This intervention development study provides the basis for subsequent work to begin to assess efficacy of this approach in a randomized controlled trial. In sum, this study provides support for the acceptability and feasibility of a novel, tailored videoconferencing intervention to address chronic pain and unhealthy alcohol use among PLWHA.
Acknowledgements
The authors wish to thank the CARE unit research associates at the Boston Medical Center, Jasmin Choi, Alexandra Chretien, and Susie Kim for their efforts in study implementation.
Funding Details
This work was supported in part by the National Institute on Alcohol Abuse and Alcoholism under Grant UH2 AA026192.
Footnotes
Disclosure of Interest
The authors report no conflict of interest.
Given the sample size of this study, the main focus of this study was to provide data relevant to acceptability and feasibility rather than efficacy. Median change in symptom outcomes provided descriptive symptom data relevant to intervention utility. For completeness, we also provide results of dependent sample t-tests on pain severity, t(6) = 7.56, p = .03; pain interference t(6) = 6.71, p = .04; heavy drinking episodes, t(6) = 4.35, p = .08, and weekly drinking, t(6) = 3.15, p = .13.
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