Researchers and research organizations acknowledge the importance of paying research participants but often overlook the process of providing participant payments as a locus for improving equity and inclusion in clinical research. In this conceptual paper, we argue that participants’ lived experiences and social context should be recognized and respected when developing these processes.

We consider how participant payment processes that require specific payment types, delay the timing of payment, or require sharing sensitive information may impose barriers to equitable research. Building on findings from empirical research of participants’ perspectives on respect in research and a relational ethics framework of person-oriented research ethics, we explore how researchers and research organizations can better demonstrate respect through the research participation payment process.

We propose five considerations for demonstrating respect when providing payment: (1) practice cultural humility, (2) be mindful of socioeconomic factors, (3) be flexible, (4) be transparent, and (5) maintain open communication. These considerations are intended to address the lack of existing ethical guidance around the process for participant payments and promote more inclusive clinical research. We provide a set of sample questions for research teams to consider how they could modify their payment processes to better demonstrate respect.

By better demonstrating respect for participants when providing payment, researchers can work toward ensuring that their research procedures are more inclusive, respond to the needs of diverse communities, and result in more equitable relationships with participants.

Disturbances in the hypothalamic-pituitary-thyroid (HPT) and hypothalamic-pituitary-adrenal (HPA) axes have been frequently reported in treatment resistant depressed patients (TRDs). So far, the effects of intermittent theta-burst stimulation (iTBS) treatment—a form of repetitive transcranial magnetic stimulation (rTMS) technique—on the activity of the HPT and HPA axes are poorly understood.

The present study aimed to evaluate the effects of iTBS sessions, applied to the left dorsolateral prefrontal cortex, in TRDs with abnormal chronobiological HPT functioning at baseline (BL) possibly associated with hypercortisolemia.

The ∆∆TSH test (i.e., the difference between the thyrotropin response to protirelin tests [∆TSH] performed at 8 AM and 11 PM on the same day) and the dexamethasone suppression test (DST) were performed in 12 TRDs and 14 healthy hospitalized control subjects (HCs). To be enrolled in this study, patients had to show at BL reduced ∆∆TSH values (i.e., < 2.5 mU/L) and a score of 18 or greater on the 17-item Hamilton Rating Scale for Depression (HAMD-17). Post-DST cortisol maximum (CORmax) serum level in excess of 120 nmol/L defined DST non-suppression (i.e., hypercortisolemia)—6 TRDs were DST non-suppressors at BL. After 10 and 20 iTBS sessions the ∆∆TSH test and the DST were repeated in all inpatients. A positive clinical response was defined by a final HAMD-17 score ≤ 8.

Compared to HCs, ∆∆TSH values were lower in TRDs at BL (p < 0.00001), and remained reduced after 10 and 20 iTBS sessions (p < 0.001 and p < 0.02 respectively). Post-DST CORmax levels were higher in TRDs than in HCs at BL (p < 0.01), but were comparable to those of HCs after 10 and 20 iTBS sessions. Responders (n = 5) were characterized by 1) a normalization of their ∆∆TSH values after 20 iTBS sessions (whereas after 10 iTBS sessions ∆∆TSH values were still reduced compared to HCs [p < 0.05]), and 2) a normality of post-DST CORmax levels at BL—while after 10 and 20 iTBS sessions post-DST CORmax levels were decreased compared to HCs (p < 0.006 and p < 0.03 respectively). Non-responders (n = 7) showed 1) no significant change in their ∆∆TSH values which remained lower than those of HCs at each assessment (all p < 0.001), 2) while increased post-DST CORmax levels found at BL (p < 0.0008 vs. HCs) normalized from the 10th iTBS session.

The present pilot study suggests that successful iTBS treatment can restore the chronobiological activity of the HPT axis. Although iTBS may increase glucocorticoid receptor signaling, baseline hypercortisolemia could negatively impact subsequent response to iTBS treatment.

None Declared

Efforts are critically needed to increase the armamentarium of options that clinicians can use to treat patients with alcohol use disorder (AUD). Numerous preclinical studies support the hypothesis that mineralocorticoid receptor (MR) pharmacological antagonism may represent a novel and promising treatment for AUD. Namely, the non-selective MR antagonist spironolactone dose-dependently decreased 1) the intake of alcohol in mice in a model of alcohol binge drinking procedure and 2) alcohol self-administration in dependent and non-dependent rats (Farokhnia, Rentsch, Choung et al., Mol Psychiatry 2022; 27(11):4642-4652). Furthermore, two U.S.-based independent human pharmacoepidemiologic studies utilizing electronic health records data showed that patients treated with spironolactone for any indication reduced their weekly alcohol use in a primary care-type medical setting (Palzes et al., Neuropsychopharmacology 2021; 46(12):2140-2147) and Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score in a Veterans Affairs medical setting (Farokhnia, Rentsch, Choung et al., 2022; 27(11):4642-4652). In both studies, spironolactone-treated patients were compared to matched ones without spironolactone prescription using propensity score matching.

We are conducting a Phase 1b human study to assess the pharmacokinetics and pharmacodynamics of spironolactone-alcohol co-administration and testing the safety and tolerability of spironolactone, alone and combined with alcohol in individuals with AUD.

Spironolactone in Alcohol Use Disorder (SAUD) is a double-blind, placebo-controlled, randomized, within-subject, ascending dose study with spironolactone (0, 100, 200, 400 mg/day) PO for 5 days to reach steady-state, followed by oral fixed-dose alcohol administration aimed at reaching a blood alcohol level of approximately 0.08 %. Our sample consists of 12 adults diagnosed with AUD.

The primary endpoint is to measure spironolactone and alcohol PK during concomitant administration. Our secondary endpoints are 1) assessment of subjective and cognitive effects of acute alcohol administration during concomitant spironolactone treatment; 2) number and severity of adverse events (AEs) experienced, compared between placebo (0 mg/day) and all three spironolactone doses; 3) PK characteristic of spironolactone active metabolites, canrenone, 7-α-thiomethylspirolactone (TMS) and 6β-hydroxy-7α-thiomethylspirolactone (HTMS), before and after administration of alcohol. Recruitment is underway.

The above-mentioned preclinical and clinical evidence suggest that spironolactone may be repurposed for the treatment of AUD. Our Phase 1b study is a key step before moving to larger efficacy trials.

None Declared

This study investigated the challenges and support needs of adults aged 75 and older during and after treatment for a blood cancer to aid targeted supportive resource development.

Adults aged 75 and older with a blood cancer participated in in-depth, semi-structured interviews about challenges and unmet support needs. Participants recruited through The Leukemia & Lymphoma Society were (1) in treatment or previously in treatment for a blood cancer at age 75 or older and (2) living in the United States or its territories. A thematic analysis was conducted with findings compared between 2 groups: (1) chronic -living with a chronic blood cancer; (2) acute -living with an acute blood cancer or both an acute and chronic blood cancer.

Participants (n = 50) ranged from 75 to 91 years old. Both groups described similar experiences and identified 5 challenges and support needs: (1) socioemotional impact, (2) activities of daily living and instrumental activities of daily living (ADLs/iADLs), (3) uncertainty management, (4) treatment-related stressors, and (5) COVID-19-related strain. Properties for these themes illustrate challenges and support needs, with some differences between groups. For instance, those living with a chronic blood cancer highlighted financial strain with treatment-related stressors, while those with an acute blood cancer focused more on iADLs.

Findings inform an agenda for targeted resource development for older adults with a blood cancer nearing the end of the life span. Results demonstrate the need for supportive services and family communication interventions to help patients manage iADLs and navigate socioemotional needs and challenges.

Studies consistently show that patients with prescription opioid use disorder (OUD) respond to buprenorphine treatment. Few studies have followed these patients in the long-term. Our longitudinal research has shown opioid abstinence to be associated most strongly with opioid agonist/partial agonist treatment. We also found that many patients used agonist treatment inconsistently; questions remain about the benefits of intermittent opioid agonist treatment.

We examined patients during the 3.5 years following their entry into a 3-month trial of treatment for prescription OUD. The current analysis compared opioid use outcomes among patients who reported receipt of agonist treatment consistently, inconsistently, or never.

This secondary analysis (N=309) of a U.S. multi-site randomized controlled trial of treatment for prescription OUD assessed variability in receiving opioid agonist treatment during the 3.5-year follow-up period, and the association between agonist treatment and opioid abstinence. Assessments were collected at months 18, 30, and 42 following treatment entry; patients were asked if they were currently taking agonist treatment and whether they had used other opioids in the previous month. Patients with only one follow-up assessment (n=29) were excluded from this analysis.

Most patients reported current opioid abstinence on at least one follow-up visit: 38% were always abstinent, 41% sometimes, and 21% never. Twenty-three percent always reported currently using agonist treatment, 26% sometimes, and 51% never. Patients consistently reporting agonist use were most likely to always be opioid-abstinent in the past month (69%), with 25% sometimes and 6% never abstinent. Patients who never reported agonist use were equally likely to be abstinent never (32%), sometimes (35%), and always (32%). Patients who sometimes reported receiving agonists were most likely to report abstinence sometimes (65%); 14% never reported abstinence, and 21% always did.

Those consistently receiving agonist treatment were more likely to always be opioid-abstinent (69%) than those sometimes (21%) or never (32%) receiving agonists. Those never receiving agonist treatment were more likely to never report opioid abstinence (32%) than were those sometimes (14%) or always (6%) receiving agonists. Interestingly, those who sometimes received agonists were more likely to be abstinent than those who never received agonists: those who sometimes received agonists were more likely to be abstinent sometimes than those who never received agonists (65% vs. 35%) and less likely to never be abstinent than were those who never received agonists (14% vs. 32%).

Receiving opioid agonist treatment has been shown to be associated with opioid abstinence during long-term follow-up. This study shows that even those who only inconsistently receive agonists are also likely to benefit.

R. Weiss Consultant of: Alkermes, M. Griffin: None Declared

The COVID-19 outbreak is a serious global public health issue with wide-ranging negative effects on people’s lives, which is reflected in steadily rising mental health problems. In order to appropriately respond to the increased occurrence of psychiatric illness, protect mental health and strengthen resilience it is necessary to include new technologies, such as extended reality (XR) or socially assistive robots (SAR) in not only psychiatric treatment but also in the prevention of psychiatric diseases. In this context, the use of new technologies offers innovative ways to strengthen resilience, self-efficacy and stress coping skills and plays an important role in improving psychological wellbeing.

Preliminary results from studies at the Clinical Department of Psychiatry and Psychotherapeutic Medicine in Graz, Austria, dealing with new technologies in psychiatry, show new options for psychiatric settings.

Project AMIGA: The aim of this study is to test the effectiveness of a cognitive training session, conducted with the SAR named Pepper. In this randomized controlled trial, the effectiveness of SAR on depressive symptoms and correlates is evaluated in a sample of 60 individuals with major depression. While the intervention group will receive cognitive training with the SAR Pepper, the control group will receive “treatment-as-usual” therapy with a common PC software. Participants will receive 30 minutes of training 2 times per week over a period of 3 weeks.

Project XRes4HEALTH: The aim of this study is to develop an XR resilience training to increase resilience and stress coping mechanisms in healthcare workers. A total of 40 people will be included. To test the effectiveness of the resilience training, 3 XR training sessions of 15 minutes each will be held. A pre-post measurement will test the effectiveness of the training on wellbeing and stress levels as well as the acceptance and satisfaction with the training.

Project AI-REFIT: The overall goal of this study is to explore key information to increase resilience in healthy individuals who are at increased risk for mental health problems. Through a usability study, the artificial intelligence-based prototype app of the resilience training will be tested for acceptance, usability, functionality, and efficiency. During the resilience training, participants are wearing a smartwatch which measures psychophysiological parameters. Conclusions about the success of the therapy can be drawn based on digital data acquisition.

New technologies including XR and SAR support classical psychiatric treatment in the topics of resilience and cognitive training as an add-on therapy in times of reduced availability of healthcare workers.

The rapid development of new technologies holds a lot of potential in the treatment of psychiatric disorders, which is why it is important to scientifically evaluate those innovative tools.

None Declared

Recovery from substance use disorder requires sustained effort and perseverance. Grit is a resilience factor that may be important for people in recovery. Little research has been conducted on grit in patients with substance use disorder, especially in a large and varied sample.

To examine the Short Grit Scale (Grit-S) in patients with substance use disorder, our aims were to analyze its psychometric properties and use demographic and clinical characteristics to predict variance in Grit-S scores.

In this study of patients in treatment for substance use disorder, participants completed the Grit-S and other self-report measures. The psychometric properties of the Grit-S were assessed in outpatients (N=94) and a hierarchical regression was used to predict Grit-S variance in inpatients (N=1238).

The Grit-S demonstrated good internal consistency (α=.75) and strong test-retest reliability (unadjusted r=.81, adjusted r=.79, p values<.001). The mean Grit-S score was 3.15, which was lower than other clinical samples reported in the literature. Regression modeling indicated a moderate, statistically significant association between demographic and clinical characteristics and Grit-S scores (R2=15.5%, p<.001).

Of particular interest, the positive factor of recovery protection showed the strongest association with grit of all the variables assessed. Hence the positive construct of grit was correlated with other positive constructs, as well as with risks. Longitudinal assessment of grit and substance use could measure the stability and clinical significance of grit throughout recovery.

M. Griffin: None Declared, R. Weiss Consultant of: Analgesic Solutions, WCG, & Alkermes, C. Trinh: None Declared

This study investigated the frequency of ear canal protection use and looked at its influence on external auditory exostosis severity and knowledge about external auditory exostosis among windsurfers and kitesurfers on the German coast.

This retrospective cross-sectional study interviewed 130 windsurfers and kitesurfers along the German coast on knowledge of external auditory exostosis, exposure time, use of neoprene hoods and earplugs, and otological complaints. Participants underwent bilateral video-otoscopic examination.

Knowledge of external auditory exostosis was ‘good’ or ‘excellent’ in 78 of 130 (60 per cent) individuals and ‘poor’ or non-existent in 52 of 130 (40 per cent) individuals. Knowledge was positively correlated with hours of exposure, otological complaints and frequency of ear canal protection use. A significant negative influence of neoprene hood use on external auditory exostosis severity was shown.

The positive effect of external auditory exostosis knowledge on the frequency of ear canal protection and the reduction of external auditory exostosis risk implies a need for health education on this topic.

Cannabis use has been linked to psychotic disorders but this association has been primarily observed in the Global North. This study investigates patterns of cannabis use and associations with psychoses in three Global South (regions within Latin America, Asia, Africa and Oceania) settings.

Case–control study within the International Programme of Research on Psychotic Disorders (INTREPID) II conducted between May 2018 and September 2020. In each setting, we recruited over 200 individuals with an untreated psychosis and individually-matched controls (Kancheepuram India; Ibadan, Nigeria; northern Trinidad). Controls, with no past or current psychotic disorder, were individually-matched to cases by 5-year age group, sex and neighbourhood. Presence of psychotic disorder assessed using the Schedules for Clinical Assessment in Neuropsychiatry and cannabis exposure measured by the World Health Organisation Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).

Cases reported higher lifetime and frequent cannabis use than controls in each setting. In Trinidad, cannabis use was associated with increased odds of psychotic disorder: lifetime cannabis use (adj. OR 1.58, 95% CI 0.99–2.53); frequent cannabis use (adj. OR 1.99, 95% CI 1.10–3.60); cannabis dependency (as measured by high ASSIST score) (adj. OR 4.70, 95% CI 1.77–12.47), early age of first use (adj. OR 1.83, 95% CI 1.03–3.27). Cannabis use in the other two settings was too rare to examine associations.

In line with previous studies, we found associations between cannabis use and the occurrence and age of onset of psychoses in Trinidad. These findings have implications for strategies for prevention of psychosis.

Extensive evidence indicates that rates of psychotic disorder are elevated in more urban compared with less urban areas, but this evidence largely originates from Northern Europe. It is unclear whether the same association holds globally. This study examined the association between urban residence and rates of psychotic disorder in catchment areas in India (Kancheepuram, Tamil Nadu), Nigeria (Ibadan, Oyo), and Northern Trinidad.

Comprehensive case detection systems were developed based on extensive pilot work to identify individuals aged 18–64 with previously untreated psychotic disorders residing in each catchment area (May 2018–April/May/July 2020). Area of residence and basic demographic details were collected for eligible cases. We compared rates of psychotic disorder in the more v. less urban administrative areas within each catchment area, based on all cases detected, and repeated these analyses while restricting to recent onset cases (<2 years/<5 years).

We found evidence of higher overall rates of psychosis in more urban areas within the Trinidadian catchment area (IRR: 3.24, 95% CI 2.68–3.91), an inverse association in the Nigerian catchment area (IRR: 0.68, 95% CI 0.51–0.91) and no association in the Indian catchment area (IRR: 1.18, 95% CI 0.93–1.52). When restricting to recent onset cases, we found a modest positive association in the Indian catchment area.

This study suggests that urbanicity is associated with higher rates of psychotic disorder in some but not all contexts outside of Northern Europe. Future studies should test candidate mechanisms that may underlie the associations observed, such as exposure to violence.