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.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,cannabis vertical farming 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. A parallel mixed-effects, logistic regression model was used for the dichotomous outcome. 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 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,grow cannabis in containers 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. These results provide strong support for future research that evaluates the role of movement therapies such as tai chi in reducing risk of falls, mobility-related disability and frailty occurrence in older PLWH. This study has several strengths. This is the first study, to our knowledge, employing a multi-component behavioral intervention to address both chronic pain and substance use in older PLWH. Another strength is that we conducted the study in partnership with a community-based agency serving PLWH, and trained its staff to deliver the multi-component intervention, so our model of implementation was pragmatic by design. Several limitations, however, warrant attention. We enrolled English speaking participants only, therefore the extent to which the results generalize to non-English speaking patients remains unclear. The same person conducted recruitment and all study assessments and was therefore not blinded to group assignment. We elected to have rolling enrollment of the groups and this may have affected group cohesion and reduced the efficacy of the CBT protocol. Some of the staff who led the CBT group sessions also led the support groups which could have contributed to some of the beneficial effects observed in the latter group through contamination bias. We also compensated participants to attend the CBT, TC and SG sessions, which likely enhanced participation rates and reduces generalizability, as this is not feasible in non-study settings.
It may also be challenging to implement the tai chi component of the intervention with fidelity in community-based settings as skilled instructors may be difficult to find, depending on location, and therefore using other modalities such as technologies to facilitate remote tai chi could enhance real world implementation. In conclusion, this pilot study demonstrates the feasibility and acceptability of a combined behavioral therapy in a vulnerable and understudied population, as well its preliminary efficacy in reducing substance use and improving physical performance. Suggestions for improvements to the CBT component of the intervention and inclusion of additional text messages will be addressed in a larger study to enhance the intervention’s potential efficacy in further reducing substance use and pain. The next steps, to refine the intervention and test it in a larger RCT, are warranted by the data and needed to facilitate effective and accessible interventions to address substance use, pain and physical performance in the growing population of older PLWH. Despite efforts to improve mental health over the last 60 years, suicide remains a critical public health concern worldwide.Suicide was the second leading cause of death globally in 2012 among individuals aged 15–29years,with an estimated 80%–90% of suicide deaths attributable to mental health or substance use disorders.Significant gaps remain in empirical research examining suicidality among marginalised populations. Marginalised women, such as sex workers who are street involved or use drugs, experience disproportionately high levels of social and health-related risks and harms, including stigma, discrimination and violence as a result of dynamic structural drivers including poverty, criminalisation and racism. While sex workers are a diverse population working from indoor in-call and out-call venues to street-based settings, previous studies highlight substantial unmet mental health needs of more marginalised and street-involved sex workers. Studies among street-based sex workers and those who use drugs underscore the associations of social exclusion, depression and post-traumatic stress disorder with suicidality.Research demonstrates greater risk for suicidality among those with a history of trauma and among street-involved sex workers who report historical experiences of violence and childhood abuse.Furthermore, indigenous women are vastly over-represented among street-based sex workers in North America and face devastating and multi-generational effects of trauma and socioeconomic dislocation as a result of colonialism, racialised policies and displacement from land and home communities.Various biological, interpersonal and socio-structural factors contribute to our understanding of suicidal behaviours.While evidence has demonstrated that some forms of cognitive behavioural therapy and pharmacological interventions may reduce suicidality, the literature is hampered by publication bias and significant heterogeneity of strategies and outcome measures.Due to ethical challenges and limitations to studying suicide and its proxies , there remains a paucity of evidence from randomised controlled trials to support the efficacy of prevention interventions.Researchers have largely focused on examining suicidality outcomes , which may not be fully generalisable to understanding suicide or accurately evaluating treatment approaches.Furthermore, stigma continues to hinder research and reporting of suicidality.There remains an urgency to better understand pathways to suicidality, with literature highlighting the need for innovative psychological and psychosocial treatments and tailored intervention approaches for key marginalised populations.Given the complex aetiological pathways to suicide and limited effectiveness of well-established evidence-based interventions to reduce the burden of suicidality, the US National Institute of Mental Health has called for innovative research on suicide prevention and treatment for suicidality.A number of psychedelic drug therapies are being revisited following a 40-year hiatus in research into their potential for the treatment of depression, anxiety, PTSD, eating disorders and addiction.Psychedelic drugs include the classic serotonergic psychedelics or ‘hallucinogens’ lysergic acid diethylamide , psilocybin, dimethyltryptamine and mescaline, as well as the ‘enactogen’ or ‘empathogen’ methylenedioxymethamphetamine , all of which are being investigated in clinical/preclinical studies for their neuropharmacological functions and potential as adjuncts to psychotherapy.