Wiidookaage'win: Beta-test of a Facebook group intervention for Native women to support opioid use recovery.

INTRODUCTION: The ongoing opioid misuse epidemic has had a marked impact on American Indian/Alaska Native (AI/AN) communities. Culture- and gender-specific barriers to medically assisted recovery from opioid use disorder (OUD) have been identified, exacerbating its impact for AI/AN women. Wiidookaage'win is a community-based participatory research study that aims to develop a culturally tailored, moderated, private Facebook group intervention to support Minnesotan AI/AN women in medically assisted recovery from OUD. The current study assessed the preliminary feasibility and acceptability of the intervention in a beta-test to inform refinements before conducting a pilot randomized controlled trial (RCT). METHODS: The intervention was beta-tested for 30 days. Moderators were trained prior to delivering the intervention. Study assessments were conducted at baseline and post-intervention. The post-intervention assessments included substance use (self-report and urine drug screen), treatment acceptability, mental health, and spirituality outcomes. We examined intervention engagement patterns using Facebook metrics and qualitatively explored common topics that emerged in participant posts and comments. RESULTS: Ten AI/AN women taking medication for OUD (MOUD) were accrued (age range 25-62 years). Participants had been in opioid recovery a mean of 15.2 months (SD = 16.1; range = 3-60). The study participation rate (accrued/eligible) was 91 %. Nine participants completed the post-intervention survey assessment and eight completed a UDS. Acceptability was high based on the mean treatment satisfaction score (M = 4.8, SD = 0.2 out of a possible 5.0), Facebook group engagement, and positive qualitative feedback. All participants retained at post-intervention continued their MOUD treatment, and none had returned to opioid use. CONCLUSIONS: The beta-test indicated that the Facebook platform and study procedures generally worked as intended and that the intervention was largely acceptable to study participants. The results of this study phase provided valuable insights to inform refinements prior to conducting a pilot RCT to further assess the feasibility, acceptability, and potential efficacy of the intervention.

Patient Engagement in Health Coaching and Self-Management Abilities in Chronic Obstructive Pulmonary Disease.

Objective: Health coaching has the potential to improve self-management abilities (SM) in patients with Chronic Obstructive Pulmonary Disease (COPD). Patient engagement with health care providers has a beneficial effect on patient outcomes. We examined the association of patient engagement with the health coach on SM abilities in patients with COPD. Methods: We analyzed the association between the degree of engagement measured by the Working Alliance Inventory (WAI-SR) and the SM measured by the Self-Management-Ability-Scale-30 (SMAS-30) at the end of a COPD health coaching intervention. Results: The cohort included 146 moderate to severe COPD patients. The WAI-SR total score was 85% of the maximum possible scores indicating a high degree of engagement between the health coach and the patients. The WAI-SR Task and Bond domains were positively associated with SM abilities after adjusting for lung function (FEV1 %) and depression symptoms (PHQ-2). Conclusion: The degree of engagement between a health coach and patients is associated with the perception of SM abilities in patients with COPD. Our results may inform self-management intervention and clinical practice.

Wiidookaage'Win: A Community-Based Qualitative Approach to Developing a Facebook Group Intervention for Native Women to Support Recovery From Opioid Use.

PURPOSE: To develop a culturally-tailored American Indian/Alaska Native (AI/AN) women's Facebook group supporting opioid recovery as an adjunct to medication. DESIGN: Community-based, qualitative approach. SETTING: Minnesota, U.S. PARTICIPANTS: AI/AN women in opioid recovery, interested parties, and a Community Advisory Committee (CAC) of AI/AN women with lived experience, health care providers, and community members. INTERVENTION: We developed evidence-based content focusing on stress/trauma and substance use, mindfulness, responding to triggers, and supportive community resources. Additional content centered on AI/AN culture was also selected. METHOD: Interviews were conducted by two women, then transcribed and coded using content analysis with NVivo software. Results were presented to CAC for further content refinement. RESULTS: CAC members (n = 10) guided study methods, intervention development, and dissemination activities. 14 AI/AN women (mean age 36.4 years; mean 6.7 months opioid abstinence) and 12 interested parties (7 men, 5 women) were receptive to an AI/AN gender-specific Facebook group, preferring content with AI/AN people and/or text resonating with AI/AN culture (e.g., Native traditions, family, personal stories, historical trauma). Recommendations included (1) protect confidentiality, (2) retain positivity, (3) incorporate resources and exercises to build coping skills, and (4) moderators should be authentic and relatable to build trust. CONCLUSIONS: Our approach provides a model for developing culturally tailored, appealing and effective social media interventions to support AI/AN women in recovery from opioid use disorder.

Baseline Characteristics and Postdischarge Outcomes by Medication for Opioid Use Disorder Status Among Women with Polysubstance Use in Residential Treatment.

Background: Within residential treatment, medication for opioid use disorder (MOUD) is rarely offered, so little is known about group differences by MOUD status. This study characterizes samples of women receiving and not receiving MOUD and explores postdischarge outcomes. Methods: This is a secondary exploratory analysis of a residential clinical trial comparing women receiving treatment as usual (TAU) with those who also received computer-based training for cognitive behavioral therapy (CBT4CBT). Participants were N = 41 adult women with substance use disorder (SUD) who self-reported lifetime polysubstance use. Because 59.0% were prescribed MOUD (MOUD n = 24, no MOUD n = 17), baseline variables were compared by MOUD status; outcomes at 12 weeks postdischarge were compared by MOUD status and treatment condition using chi square and Mann-Whitney U tests. Results: Participants were middle-aged (41.7 ± 11.6 years) and non-Latinx Black (80.4%). Most used substances in the No MOUD group were alcohol, cocaine, and cannabis, and in the MOUD group, most used substances were opioids, cannabis, and cocaine. Women in the MOUD group tended to have more severe SUD. Postdischarge substance use recurrence rates were twice as high in the MOUD group than in the No MOUD group. Among the women in the No MOUD group, those in the CBT4CBT condition increased the number of coping strategies twice as much as those receiving TAU. Conclusion: Postdischarge substance use recurrence differed by MOUD status. CBT4CBT may be a helpful adjunct to personalized residential SUD treatment. The parent study is registered at [www.clinicaltrials.gov (ClinicalTrials.gov identifier: NCT03678051)].

Community engagement strategies to promote recruitment and participation in clinical research among rural communities: A narrative review.

Residents of rural areas are underrepresented in research. The aim of this narrative review was to explore studies describing the effectiveness of community engagement strategies with rural communities to promote participant recruitment and participation in clinical research. Following PRISMA guidelines, this narrative review was conducted in June 2020. Our search strategy was built around keywords that included community-engaged research, rural community, and recruitment strategies into clinical research. Content-related descriptive statistics were summarized. The selected articles were distributed into categories of levels of community engagement: inform, consult, involve, collaborate, or co-lead. The search resulted in 2,473 identified studies of which forty-eight met inclusion criteria. Of these, 47.1% were randomized controlled trials. The most common levels of engagement were consultation (n = 24 studies) and collaboration (n = 15), while very few focused on informing (n = 2) and co-leadership (n = 2). Strategies, limitations, and findings are discussed for each level of community engagement. This narrative addressed a gap in knowledge regarding participant recruitment in rural communities in relation to assistance from community members. Community engagement contributed to the success of the research, especially in recruitment, participation, and building trust and partnership.

Study What You Do: Developing a Psychotherapy Tracking Database in a Large-Scale Integrated Behavioral Health Service.

PURPOSE: Many individuals with behavioral health challenges receive services in primary care, and integrated behavioral health (IBH) programs can help increase access to evidence-based interventions. IBH programs can benefit substantially from integrating standardized tracking databases that allow for the implementation of measurement-based care to evaluate patient-, clinician-, and practice-level outcomes. We describe the development and integration of Mayo Clinic's pediatric and adult primary care psychotherapy tracking database. METHODS: IBH practice leaders directed the development of a large psychotherapy tracking database that continuously populates from Mayo Clinic's electronic health record system. The database captures numerous patient variables including demographics, behavioral health and substance use issues, psychotherapy principles used, and self-reported symptoms. We retrieved current data for patients empaneled in Mayo Clinic's pediatric and adult primary care psychotherapy programs from June 2014 to June 2022. RESULTS: The tracking database contained data for 16,923 adult patients and 6,298 pediatric patients. The mean age of adult patients was 43.2 years (SD 18.3), 88.1% were non-Latine White, and 66.7% identified as female. The mean age of pediatric patients was 11.6 years (SD 4.2), 82.5% were non-Latine White, and 56.9% identified as female. We provide examples of practical applications of the database across clinical, educational, research, and administrative domains. CONCLUSIONS: The development and integration of a psychotherapy tracking database supports clinician communication, examination of patient outcomes, practice quality improvement efforts, and clinically relevant research. Our description of Mayo Clinic's IBH database may serve as a model for other IBH practices.

Development and initial cognitive testing of the Digital Equity Screening Tool (DEST): Community participatory approach to assessing digital inequality.

COVID-19 has widened the existing digital divide, especially for people from socially and economically deprived communities. We describe a program evaluation using a community participatory approach to develop self-reported items of patient experience with technology inclusive of digital access and literacy. The feedback received from Community Advisory Boards and Community Engagement Studio members led to the evaluation and refinement of the individual items. The community-based participatory approach highlighted in our paper to develop these items could serve as a model for other screening tool development for enhancing equity and inclusiveness in clinical care and research.

Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial.

BACKGROUND: Cigarette smoking prevalence is higher among rural compared with urban adults, yet access to cessation programming is reduced. The Increasing Digital Equity and Access (IDEA) study aims to evaluate three digital access and literacy interventions for promoting engagement with an online evidence-based smoking cessation treatment (EBCT) program among rural adults. METHODS: The pilot trial will use a pragmatic, three-arm, randomized, parallel-group design with participants recruited from a Midwest community-based health system in Minnesota, Wisconsin, and Iowa. All participants will receive an online, 12-week, EBCT program, and written materials on digital access resources. Participants will be stratified based on state of residence and randomly assigned with 1:1:1 allocation to one of three study groups: (1) Control Condition-no additional study intervention (n = 30); (2) Loaner Digital Device-Bluetooth enabled iPad with data plan coverage loaned for the study duration (n = 30); (3) Loaner Digital Device + Coaching Support-loaner device plus up to six, 15-20 min motivational interviewing-based coaching calls to enhance participants' digital access and literacy (n = 30). All participants will complete study assessments at baseline and 4- and 12-weeks post-randomization. Outcomes are cessation program and trial engagement, biochemically confirmed smoking abstinence, and patient experience. RESULTS: A rural community advisory committee was formed that fostered co-design of the study protocol for relevance to rural populations, including the trial design and interventions. CONCLUSION: Study findings, processes, and resources may have relevance to other health systems aiming to foster digital inclusion in smoking cessation and chronic disease management programs and clinical trials in rural communities.

Quantification of diet quality utilizing the rapid eating assessment for participants-shortened version in bipolar disorder: Implications for prospective depression and cardiometabolic studies.

OBJECTIVES: Recognizing bipolar disorder as a multi-system metabolic condition driven, in part, by binge eating behavior and atypical depressive symptoms, this study aimed to quantify diet quality and evaluate clinical correlates in a bipolar disorder cohort. METHODS: Participants from the Mayo Clinic Bipolar Disorder Biobank (n = 734) completed the Rapid Eating Assessment for Participants - Shortened version (REAP-S) to determine diet quality. The average REAP-S score for a U.S. omnivorous diet is 32 (range 13 to 39) with higher scores indicating healthier diet. Demographic variables were collected in a standardized clinical questionnaire. Depressive symptoms were assessed by the Bipolar Inventory of Symptoms Scale. Cardiometabolic variables were retrieved from the electronic health record. Associations between continuous variables and REAP-S scores (total, 'healthy foods' and 'avoidance of unhealthy foods') were assessed using linear regression. RESULTS: Overall, our sample had a mean REAP-S score of 27.6 (4.9), suggestive of a lower diet quality than the average general population in the US. There was a significant inverse relationship between mean REAP-S lower scores with increased BMI, waist circumference, disordered eating and depression. All these associations were significantly stronger in female participants. LIMITATIONS: EHR cross-sectional data. CONCLUSIONS: Our data suggest unhealthy diet quality in bipolar disorder is associated with depression, obesity and cardiometabolic abnormalities. Additional work is encouraged to prospectively track mood and diet quality to further understand the bidirectional relationship and clarify if dietary interventions can positively impact mood. Further delineating potential sex differences in diet quality and depression may provide greater appreciation of modifiable risk factors for future cardiometabolic burden.

Pilot Social Network Weight Loss Intervention With Two Immigrant Populations During the COVID-19 Pandemic.

PURPOSE: To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations. DESIGN: Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs. SETTING: Community-based setting in Southeastern Minnesota, United States. SAMPLE: Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants. INTERVENTION: Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual). MEASURES: Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides. ANALYSIS: Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment. RESULTS: Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02). CONCLUSION: This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.

Association between anxiety and eating behaviors in patients with obesity.

Background: Given the link between eating behavior and obesity, it is critical to identify individuals who have eating behaviors which contribute to obesity etiology. This study aimed to investigate the potential relationship between symptoms of anxiety and eating behaviors in patients with obesity. Methods: This was a cross-sectional study analyzing baseline characteristics of 438 patients with obesity (BMI>30). Patients completed the Hospital Anxiety and Depression Scale (HADS) questionnaire, the Three-Factor Eating Questionnaire R21 (TFEQ-R21), and the Weight Efficacy Lifestyle Questionnaire (WEL). Pearson correlation coefficients were used to evaluate the association between questionnaires. Two-sample independent t-test were conducted to examine differences in the TFEQ-R21 and WEL between low and moderate to severe levels of symptoms of anxiety. Results: Anxiety scores (HADS-A) positively correlated with two factors of the TFEQ, emotional eating (r = 0.36) and uncontrolled eating (r = 0.27). The HADS-A score was negatively correlated with self-efficacy to resist eating in all five situational factors on the WEL (p < 0.01). Patients with symptoms of anxiety additionally showed higher mean scores for emotional eating and uncontrolled eating (p < 0.001, respectively),and lower levels of cognitive restraint (p = 0.04)) on the TFEQ-R21. Conclusion: Patients with obesity who reported having anxiety symptoms had lower self-confidence to manage their eating and more emotional eating than patients with low anxiety symptoms. Clearly more needs to be learned about symtoms of anxiety and eating behaviors.

Increasing Prenatal Care Compliance in At-Risk Black Women: Findings from a RCT of Patient Navigation and Behavioral Incentives.

BACKGROUND: In the USA, infant mortality remains a major public health concern, particularly for Black women and their infants who continue to experience disproportionately high mortality rates. Prenatal care is a key determinant of infant health, with inadequate prenatal care increasing risk for prematurity, stillbirth, neonatal loss, and infant death. The aim of the present study was to determine if concurrent delivery of patient navigation and behavioral incentives to at-risk Black pregnant women could improve prenatal care attendance and associated maternal and infant outcomes. METHODS: Participants were 150 Black pregnant women recruited at first prenatal visit and screening at risk for adverse maternal and infant outcomes. Women were randomized to either the patient navigation + behavioral incentives intervention (PNBI) or assessment + standard care control (ASC) group. All were followed throughout pregnancy and 12-week postpartum. Group comparisons were made using intention-to-treat and per-protocol sensitivity analyses. RESULTS: While no group differences were found in prenatal care visits, the average number of visits for both groups (9.3 for PNBI and 8.9 for ASC) approached the American College of Obstetricians and Gynecologists (ACOG) recommended guidelines. There were also no group differences in maternal and infant outcomes. Both intention-to-treat and per-protocol sensitivity analyses, however, consistently found PNBI women attended more postpartum visits than ASC controls (p = 0.002). CONCLUSIONS: Given ACOG's redefining of the postpartum period as the fourth trimester, study findings suggest PNBI may facilitate prevention and intervention efforts to more successfully reduce health disparities in outcomes for both mother and infant.

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders.

INTRODUCTION: Despite the effectiveness of cognitive behavioral therapy (CBT) for treatment of substance use disorder, dissemination to clinical practice is limited due to a range of barriers (e.g., time, cost). Computer-based training for cognitive behavioral therapy (CBT4CBT) offers a feasible and cost-effective opportunity to improve the quality and reach of SUD treatment. Research to date has supported the effectiveness of CBT4CBT in outpatient settings; however, research has not yet tested it in residential treatment. METHODS: The current study evaluated the feasibility of CBT4CBT as an adjunct to residential treatment in a sample of women with SUDs using a two-arm pilot RCT comparing women randomized to either standard residential treatment plus access to the CBT4CBT program (N = 34) or residential treatment alone (TAU; N = 29). Assessments occurred at baseline, discharge from residential care, and at 4- and 12-weeks post-discharge. The study compared the two groups over the 12-week follow-up period on relapse to any substance (Y/N), relapse to primary substance (Y/N), and days of use using chi-square for categorical and t-tests for continuous measures. The study team also performed a Kaplan-Meier analysis to compare the two groups on time to relapse. RESULTS: Demographically, the sample was predominantly African American (79.4%), with a mean age of 41.2 years (SD = 12.1). Although the current study was not powered for statistical significance, findings were in the predicted direction, with women in the CBT4CBT group reporting lower likelihood of relapse, longer time to relapse, and fewer days of substance use in the follow-up period compared to women in TAU. CONCLUSIONS: This study expands the current literature supporting the use of CBT4CBT in outpatient settings. While a fully powered trial should confirm our findings, the current study provides benchmark data on the use of CBT4CBT in residential treatment for women with SUDs.

Factors associated with treatment retention in pregnant women with opioid use disorders prescribed methadone or electing non-pharmacological treatment.

Opioid use during pregnancy is rising, with an estimated 14-22% of women obtaining an opioid prescription during pregnancy. Methadone maintenance therapy (MMT) has been the gold standard for treatment of opioid use disorders during pregnancy; however, its use is limited in clinical practice due to availability, stigma, and reluctance on the part of clinicians. The present study compared against medical advice (AMA) treatment dropout from seven days of residential care between pregnant women diagnosed with opioid dependence who elected either MMT (n = 119) or non-pharmacological treatment (NPT) (n = 91) within the same treatment program in Baltimore, Maryland from 1996 to 1998. Multiple logistic regression analysis was conducted to compare the rate of AMA drop out between the two modalities. Patients who elected NPT were 2.77 times as likely to leave residential treatment as patients who elected MMT (adjusted odds ratio [OR = 2.77, 95% confidence interval [CI]: 1.23-6.17]. AMA was associated with interviewer-assessed drug severity and patient's rating of the importance of psychiatric treatment. The present findings further support the clinical utility of MMT and suggest that policies that facilitate the implementation of MMT in clinical practice would be beneficial to the engagement and retention of pregnant women with opioid use disorders.

Gender Differences in Any-Source Caffeine and Energy Drink Use and Associated Adverse Health Behaviors.

Background: The majority of college students report caffeine use with many using caffeine daily. Energy drink (ED) use, in particular, is common among college students, and numerous studies link these heavily caffeinated drinks to a variety of adverse consequences including substance use and risky behaviors. However, little is known about correlations between any-source caffeine use and other substance use and problems. The purpose of this study was to evaluate patterns of caffeine use and examine the relationships between caffeine, in general, and EDs specifically, and adverse health behaviors in college students. Methods: We used data from a longitudinal study of alcohol use and health-related outcomes to assess caffeine, alcohol, nonprescription drug, and tobacco use and symptoms of alcohol dependence in 1958 freshmen from a mid-Atlantic university during Fall 2012. We compared adverse health behaviors between caffeine users and nonusers and ED users and nonusers. Data were evaluated separately in men and women. Results: While women reported significantly more caffeine use than men, men reported more ED use. EDs, regardless of frequency of use, were associated with all adverse health behaviors, but only in female students. Similarly, daily any-source caffeine use was significantly associated with alcohol, nonprescription drug, and tobacco use in female students, but in men, the association was less robust. Conclusions: This research shows that caffeine use is prevalent among college students, and, in female students, is associated with alcohol, nonprescription drug, and tobacco use and alcohol dependence symptoms. Interventions aimed at promoting healthy behaviors may be especially useful in this population.

Screening for substance use in pregnancy and the newborn.

Substance use during pregnancy is common, costly and associated with maternal and newborn health consequences. Assessment of substance use should be integrated into prenatal care. Substance use identification methods include patient interview, screening instruments, and biological testing. In this review, we critically evaluate screening and testing for substance use during pregnancy, highlighting the benefits and barriers of integrated assessment into prenatal care. We also discuss the limitations and negative consequences that should be considered when implementing screening and/or testing procedures. Lastly, we provide recommendations for the ethical implementation of screening and testing for substance use in the context of prenatal care.

Screening for At-Risk Alcohol and Drug Use in the Antenatal Period: How Do Young Women Compare with Older Adult Women?

STUDY OBJECTIVE: In the present study we compared results of standardized screening tools for problem alcohol and other drug use in younger (ages 18-24 years) and older (ages 25 and older) women attending the same clinic. We separately investigated pregnant and nonpregnant women. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: This was a cross-sectional study of women attending an urban, university-affiliated obstetrics and gynecology clinic. Women were recruited while awaiting appointments with their providers. In total, 3317 provided consent and completed a brief anonymous survey with standardized questions about alcohol and other drug problems. Measures included the T-ACE (acronym for Tolerance, Annoyed when others express concern, Cut down on drinking, Eye-opener) for alcohol and CAGE for other drugs (CAGE is a mnemonic for the following items: (1) Have you ever felt you should cut down on your use of other drugs? (2) Have people annoyed you by criticizing your use of other drugs? (3) Have you ever felt bad or guilty about your use of other drugs? and (4) Have you ever used drugs first thing in the morning to steady your nerves, avoid withdrawal, or get rid of a hangover [eye opener]?). Individual item responses and screener summary scores were compared separately for pregnant and nonpregnant younger (ages 18-24 years) and older adult (25 years of age or older) women using χ2 for categorical and t tests for continuous variables. RESULTS: For pregnant women, 386/1460 (26%) of older women screened at-risk for problem drinking compared to 250/1203 (21%) of younger women (P = .001). For other drugs, however, 192/1203 (16%) of younger pregnant women screened at risk compared to 186/1461 (13%) of older adult pregnant women (P = .02). For nonpregnant women, screen positive rates for at-risk drug use were nearly 2 times higher among older compared with younger women, with 48/321 (15%) of older women screening at risk compared to 28/332 (8%) of younger women (P < .01). CONCLUSION: The present findings affirm the need for routine screening for alcohol and drug problems in women of all ages, regardless of pregnancy status.

Representativeness of patients enrolled in a primary care clinical trial for heavy/problem substance use.

BACKGROUND: The extent to which participants in randomized clinical trials (RCTs) resemble their broader target groups is of particular concern when studying stigmatized conditions such as substance use disorders (SUDs). The present study compared patients who enrolled in a 4-arm clinical trial of SBIRT (screening, brief intervention, and referral to treatment) with eligible patients who declined study participation. METHODS: Participants (N = 1338) were primary care patients who anonymously completed a computer-delivered health survey and screened positive for heavy/problem alcohol or drug use. Those who consented to the RCT (n = 713) were compared with those who declined (n = 625) on a variety of demographic, substance use, and psychosocial characteristics. Variables significant at P < .20 in univariate analyses were then examined using multivariate logistic regression to determine their combined effect. RESULTS: The sample was 60% female and 76% African American, with a mean age of 45.2 years. Patients who consented to participate differed from those who declined on 34 (60%) of the 57 variables studied. The most parsimonious model by multivariate regression found that those who consented were older, more likely to be unemployed, and more likely to endorse prescription drug misuse, problems related to drug use, family history of alcohol problems, trouble falling asleep, and a health professional recommendation to lose weight. CONCLUSION: Patients consenting to the RCT reported a greater number and more severe psychosocial and mental health problems than those who declined study participation. If the higher level of risk among study participants was found in other studies as well, it would raise questions regarding the generalizability of RCT results to broader clinic samples.