Standardized fidelity ratings were made on 50% of randomly selected CBT sessions. These showed acceptable to excellent fidelity on all domains.The study employed a Yang-style tai chi delivered weekly for one hour following each CBT session. Each session started with a 10-minute warm-up, stretching and review of tai chi principles followed by 30 minutes of tai chi exercises, including five animal forms, a walking meditation, and a partnered activity known as push hands. Each class ended with a 10-minute cool down and a 5-minute closing that included a review of the material presented. A tai chi instructor with 18 years of experience trained two APAIT exercise program staff to lead the tai chi exercises. The staff underwent training for 1 hour weekly for 3 months before they began to lead tai chi sessions in the study. The trainer also attended four tai chi study sessions with each of the study instructors during the trial to monitor staff members’ instruction and provide feedback and adjustments as needed. Between November 2015 and April 2016, participants were recruited by a research assistant who distributed flyers at venues serving PLWH, including APAIT, gave presentations at nearby health agencies, and approached potential participants at health centers. A flow diagram shows the number of individuals approached, screened, and recruited, as well as losses to follow-up. Randomization was conducted by research staff who used consecutively numbered, sealed envelopes containing assignment information using a computer-generated set of random numbers to select permutated blocks of six. Within each block, equal numbers were assigned to each of the three groups. Participant follow-up concluded in July, 2016. Participants were compensated for their time via gift cards. Participants in the CBT/TC/TXT arm could be compensated up to $280,indoor vertical farm those in the SG arm could be compensated up to $200, while subjects in the AO arm could be compensated up to $120. Compensation included $10 for attending each CBT, TC or SG session.
Demographic and health-related data included date of birth, gender, race/ethnicity, education, marital status, housing arrangement, employment status, number of years living with HIV, most recent CD4+ T lymphocyte count and HIV-1 RNA [detectable or undetectable ] and number of non-HIV chronic medical conditions. Participants also completed mental and physical health measures . Substance use data included most often used substance and the total number of substances used. Substances included both drugs and alcohol. Substance use measures included the WHO ASSIST-Version 3 and the Timeline Follow back . The TLFB was used to determine the number of days in the past 30 days of a) using a preferred substance; b) using any substance; c) using any drugs; and d) heavy drinking . Pain data included number of years of chronic pain, and medications used to treat pain. Pain measures included two items from the abbreviated Brief Pain Inventory , i.e., average self-rated pain intensity and percent pain relief in the past 24 hours from pain treatments , the Pain Self-Efficacy Questionnaire, and the modified Roland-Morris Disability Questionnaire. Data were collected via self-administered paper and pencil surveys. Physical performance was assessed with the Short Physical Performance Battery . We calculated a total SBBP score for each participant and determined the percentage of participants with low physical performance versus high physical performance. In person assessments were conducted at APAIT at baseline, and at 8- and 12- weeks after the baseline assessment. All measures were collected at baseline. In addition, the substance use measures based on the TLFB, the pain measures including the BPI, PSEQ and RMDQ and the physical performance measure, the SPPB were collected again at 8- and 12-weeks. Feasibility was assessed by a) success of recruitment and randomization, b) retention and treatment engagement rates, and c) feedback about the study from participants. Bivariate analyses were used to a) compare groups at baseline to assess the success of randomization, b) compare treatment retention and engagement between groups, and c) determine associations between baseline variables, treatment adherence and engagement. Measures of treatment efficacy included reductions in substance use, pain, and pain-related disability, as well as improvements in physical performance. Changes in outcome variables between baseline and both 8 weeks and 12 weeks are reported as means, standard deviations and medians for each group. Because the data were not normally distributed, we used the non-parametric, Wilcoxon signed rank test in each group to test if the within-individual change in the group was statistically significantly different from zero change.
To assess the preliminary efficacy of the intervention, we conducted an intention-to-treat analysis-all individuals randomized in the study were included in the analyses whether they received treatment or not using baseline, 8-, and 12-week follow-up data for each dependent variable. Linear, mixed-effects models were used to evaluate the five continuously scaled outcomes , with treatment group as a between-individuals factor , time as a within-individuals factor , and a group-by-time interaction to examine differences in the magnitude of change between groups.Poisson regression models were used for the four count outcomes . From the fitted model, to estimate treatment effects, we evaluated three between-group pairwise comparisons of change over time. Poisson regression models estimate within-group change as a count ratio , and the treatment effect estimate is the ratio of two CRs. The treatment effect estimates from the linear regression models are between-group differences in the magnitude of the change from baseline . The logistic regression model estimates within-group change as an odds ratio ,and the treatment effect estimate is the ratio of two ORs. Since change at 12 weeks was greater than the change at 8 weeks for most outcomes, we treated time as a continuous variable: actual number of days elapsed from baseline to the date of the follow-up, divided by 30 . These models were adjusted for baseline number of different types of substances used because 12-week follow-up participation rates varied significantly by baseline values of this variable Most used substances included alcohol, cannabis and stimulants, and the mean number of substances used by each participant was 2.69 . ASSIST scores indicated that most participants had moderate or high risk substance use. On average, in the prior 30 days, participants reported using their preferred substance, any substance, and drugs on more than half of the days, as well as 3.2 days of heavy drinking . Participants reported having chronic pain an average of 10.6 years. The mean pain intensity score was 6.9, and percent pain relief provided by any treatment in the past 24 hours was 50.7%. The mean score on the Short Physical Performance Battery was 8.0 and the percentage of those with low physical performance on the SPPB was 48%.
From baseline to 12 weeks, the CBT/TC/TXT group had statistically significant reductions in all four substance use outcomes: days of using preferred substance in the past 30 days , days of using any substance in past 30 days , days of using drugs in past 30 days , and days of heavy drinking in past 30 days . The support group also showed a statistically significant reduction in the number of days of preferred substance use in the past 30 days,vertical farming equipment from baseline to 12 weeks .Statistically significant improvements were observed in both physical performance outcomes in the CBT/TC/TXT group from baseline to 8 weeks and from baseline to 12 weeks . The median change in % with low physical performance was 0 but the signed rank sums are statistically different at each time point. The SG showed a statistically significant improvement in SPPB score from baseline to 12 weeks .Significantly greater reductions were observed in the CBT/TC/TXT group, relative to the AO group in three of the four substance use outcomes . As compared to the AO group, the CBT/TC/TXT group had a 2% greater relative reduction per month in the number of days of using their preferred substance, a4% greater relative reduction per month in the number of days of using drugs in the past 30 days, and a 19% greater per month reduction in number of days of heavy drinking in the past 30 days. We observed similar findings when comparing the CBT/TC/TXT group to the SG . Sixteen CBT/TC/TXT participants provided feedback about the study. Overall feedback was very favorable; two-thirds wished that the eight-week program and the one hour sessions lasted longer, while the remainder thought the individual program components and session length were adequate. Most rated the CBT group and tai chi sessions as extremely useful and enjoyed working with the therapist/instructor . About 70% of the CBT/TC/TXT participants indicated that they would definitely attend this type of group therapy if it were offered by APAIT with no compensation and not as part of a study. Suggestions for additional topics to address included stigma, HIV and aging, and more education about various medical conditions. Two participants suggested including a male facilitator living with HIV and one suggested having the groups available in Spanish. Related to the text messaging component, 69% reported it was extremely important in helping them to make or maintain a change. Fifty-six percent would have liked to receive the messages for longer than 8 weeks, and 50% thought two motivational texts a week was not enough. This study demonstrated that a multi-component behavioral intervention addressing substance use, pain, and physical performance in older PLWH with comorbid substance use and pain disorder conducted in partnership with a community-based agency is feasible, acceptable and has preliminary efficacy.
Importantly, our enrolled population used multiple substances, had ASSIST scores indicating moderate to high risk substance use, long term chronic pain and high rates of low physical performance at baseline. Feasibility and acceptability indicators showed moderate levels of participant enrollment , excellent 12-week assessment completion , acceptable to excellent CBT treatment fidelity ratings, and high attendance at CBT and tai chi sessions . Our qualitative data highlight overall positive program feedback and provide suggestions for changes to study procedures to enhance study efficacy. Anecdotally, we also learned from study staff about some of the barriers to attending the group based sessions including illness, drug use, lack of stable housing, and transportation issues. We also learned that most participants did not complete the homework assigned to them as part of the CBT component. We hypothesized that the intervention would lead to reductions in substance use and pain outcomes and improve physical performance. Looking first at within-group changes, statistically significant improvements from baseline to 12 weeks were observed in the CBT/TC/TXT group for all four substance use outcomes, one pain outcome and both physical performance measures. In the SG, from baseline to 12 weeks, statistically significant improvements were seen for one substance use and one pain and one physical performance outcome. In the AO group, no statistically significant within group improvements were observed from baseline to 12 weeks. Looking next at between-group changes, we observed several statistically significant between-group changes, most importantly in days of heavy drinking and in the SPPB score. The substance use change scores were modest except for days of heavy drinking in which, compared to the AO group, the CBT/TC/TXT group and SG had large relative reductions . We also observed a significant between group treatment effect with respect to perceived relief obtained from pain treatments over the past 24 hours suggesting that the intervention may improve quality of pain management. This is important given that both the mean and median self rated pain intensity among participants at the time of enrollment was moderately severe . We did not, however, observe any meaningful treatment-related reductions in pain intensity or perceived disability due to pain. Possible explanations for these latter findings include that most participants’ pain was of a neuropathic origin, which has not been shown to respond to psychological interventions when used as stand-alone therapy . In addition, our intervention merged elements of pain and substance use behavioral treatments such that the dose of pain coping skills training, behavioral activation, and cognitive restructuring may have been insufficient. Also as participants did not complete the homework exercises, which serve to reinforce the use of the techniques and suggests that adoption of the behavioral strategies to manage pain both during and after the intervention period was limited. With respect to the physical performance outcomes, SPPB score improved in the CBT/TC/TXT group relative to both the AO and SG of a magnitude indicative of meaningful improvement .