Corey R. Roos

There is a lack of accessible and efficacious interventions for emotionally distressed adults. We developed a single-session digital intervention, called Visitor Mindset, targeting beliefs about negative emotions and awareness, clarity, and acceptance of negative emotions. We evaluated the acceptability, feasibility, and short-term efficacy of Visitor Mindset among emotionally distressed adults (n = 530). Participants were recruited via CloudResearch and randomized to Visitor Mindset or control (nature videos with relaxing music). The primary outcome was emotional distress. Secondary outcomes were functional impairment and alcoholic drinks per week. Outcomes were assessed before randomization and at 2-week follow-up. All participants randomized to Visitor Mindset completed the intervention. Acceptability ratings (e.g., perceived helpfulness) for Visitor Mindset were favorable. There was not a significant difference in changes in emotional distress between treatment conditions (d=0.13, p>.05). However, Visitor Mindset, versus control, resulted in greater reductions in functional impairment (d=0.21, p< .05) and drinks per week (d=0.21, p< .05). Improvement in acceptance and reduction in the belief negative emotions last a long time significantly mediated the effects of Visitor Mindset on emotional distress and functional impairment (p's< 0.05), but not drinks per week. Among participants with at least moderate-to-severe emotional distress, the effect of Visitor Mindset on emotional distress in this case was significant (d=0.34, p< .05), and the effect of Visitor Mindset on functional impairment was stronger (d=0.31, p< .05) in this subsample relative to the effect in the full sample. Functional impairment, but not other outcomes, demonstrated clinical significance. That is, Visitor Mindset participants were 61% more likely than control participants to change from a clinical score to a subclinical score for functional impairment. Visitor Mindset is feasible and acceptable, and may be promising for improving functioning and reducing alcohol use among emotionally distressed adults. Additionally, Visitor Mindset appears to mobilize theorized mechanisms. Future research is warranted with longer-term follow-ups.

Background: Globally, approximately 8.6% of people will meet criteria for alcohol use disorder (AUD) in their lifetimes, with 2.2% meeting criteria for AUD in the past 12 months. In the United States, AUD prevalence is even greater, with 13.9% meeting criteria in the past 12 months. Effective treatments for AUD exist, although most people receive help through mutual support groups (ie, Alcoholics Anonymous [AA]). However, AA and other mutual support programs may not be desirable for all individuals, particularly those who do not seek abstinence-based approaches. Treatments that support reductions in drinking have been shown to be as effective as abstinence-based treatments in reducing alcohol-related harms, and may be more appealing to a broader range of people. Mindfulness-based interventions may be particularly effective in supporting long-term recovery, whole-person health, and functioning for those with abstinent and nonabstinent recovery goals. Objective: This study is designed to test a novel rolling group-based mindfulness-based relapse prevention (MBRP) delivered via videoconferencing, focused on drinking reduction goals and whole-person functioning. Methods: This study is a hybrid type 1 effectiveness-implementation design to prospectively test the effectiveness of MBRP and to identify barriers and facilitators of group participation to inform future implementation of MBRP as continuing care. Individuals with AUD (n=470) interested in stopping or reducing their drinking, meet criteria for AUD based on a symptom checklist, report heavy drinking at least once in the past 6 months, consent and understand study procedures in English, and provide a valid US mailing address are recruited nationwide via online sources in the United States. Participants are randomized to either MBRP groups via Zoom (Zoom Video Communications, Inc) or referral to online mutual support (eg, AA). All participants receive an individual orientation session delivered via Zoom that includes brief motivational interviewing and an overview of their assigned condition and next steps (MBRP condition: overview of the MBRP groups and instructions on participating in MBRP via Zoom; referral condition: referral to online mutual support groups). Participants provide blood samples for phosphatidylethanol testing at baseline and 3-year follow-up and complete self-report measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. Results: Recruitment began on September 13, 2023, and the last recruited participant was randomized on March 20, 2025. Follow-up data collection is ongoing with all 6-month follow-ups completed (86% retention). Conclusions: This study evaluates the effectiveness and mechanisms of MBRP delivered via videoconferencing, compared with referral to online mutual support groups, in supporting recovery among individuals with AUD. It also examines the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible, freely available continuing care option to support long-term recovery from AUD.

Background: Cognitive behavioral therapy (CBT) is the most effective treatment for binge eating disorder (BED) but is limited by modest efficacy and low reach of in-person delivery. Combining mindfulness training with CBT could enhance efficacy by targeting emotion dysregulation, a key factor in BED that CBT does not adequately target. Digital delivery can enhance the reach of treatment. Accordingly, we developed CBT-based Mindful Courage, a 16-session digital intervention combining CBT and mindfulness training for BED. Objective: The aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility (intervention and assessment completion) and acceptability (usability, overall satisfaction, engagement, visual appeal of content, understandability of program content, desire to continue the program, perceived skill acquisition, perceived confidence in implementing skills, and perceived helpfulness) of CBT-based Mindful Courage. We will also evaluate changes in outcomes (binge eating frequency, eating disorder symptoms, clinical impairment, and depression symptoms) and mechanisms (emotion dysregulation, dietary overrestriction, and trait mindfulness). Methods: This is a parallel-group, single-blinded, randomized controlled trial with a 1:1 allocation ratio. It will be conducted from November 2025 to November 2026, with study assessments at baseline, midtreatment, end-of-treatment, and 2-month follow-up. We will recruit a volunteer sample of adults with BED (N=40) aged 18 to 75 years via online advertisements. Exclusion criteria include a BMI <18.5, current anorexia or bulimia nervosa, and current treatment for BED or weight loss. Participants will be randomly allocated to an active control that includes coached self-monitoring (self-monitoring of food intake in Recovery Record and coaching calls by a research assistant) or to CBT-based Mindful Courage+coached self-monitoring. Both conditions will have a duration of 18 weeks. All study sessions will take place over Zoom. Results: The study was funded in April 2023. Data collection began in November 2025, and we anticipate recruitment to be completed by November 2026. Results are expected to be analyzed by May 2027 and published by May 2028. Conclusions: This will be an important first step in creating a scalable and efficacious treatment for BED. Trial Registration: ClinicalTrials.gov NCT07212673; https://clinicaltrials.gov/study/NCT07212673 International Registered Report Identifier (IRRID): DERR1-10.2196/91761

BACKGROUND Globally, approximately 8.6% of people will meet criteria for alcohol use disorder (AUD) in their lifetimes, with 2.2% meeting criteria for AUD in the past 12-months. In the United States, AUD prevalence is even greater with 13.9% meeting criteria in the past 12-months. Effective treatments for AUD exist, although most people receive help through mutual support groups (i.e., Alcoholics Anonymous (AA)). However, AA and other mutual support programs may not be desirable for all individuals, particularly those who do not seek abstinence-based approaches. Treatments that support reductions in drinking have been shown to be as effective as abstinence-based treatments in reducing alcohol-related harms and may be more appealing to a broader range of people. Mindfulness-based interventions may be particularly effective in supporting long-term recovery and whole person health and functioning for those with abstinent and non-abstinent recovery goals. OBJECTIVE This study is designed to test a novel rolling group-based mindfulness-based relapse prevention (MBRP) delivered via video conferencing, focused on drinking reduction goals and whole-person functioning. METHODS This study is a hybrid Type 1 effectiveness-implementation design to prospectively test the effectiveness of MBRP, and to identify barriers and facilitators of group participation to inform future implementation of MBRP as continuing care. Individuals with AUD (n=470) interested in stopping or reducing their drinking, meet criteria for AUD based on a symptom checklist, report heavy drinking at least once in the past 6 months, consent and understand study procedures in English, and provide a valid United States mailing address are recruited nationwide via online sources in the United States. Participants are randomized to either MBRP groups via Zoom or referral to online mutual support (e.g., AA). All participants receive an individual orientation session delivered via Zoom that includes brief motivational interviewing and an overview of their assigned condition and next steps (MBRP condition: overview of the MBRP groups and instructions on participating in MBRP via zoom; Referral condition: referral to online mutual support groups). Participants provide blood samples for phosphatidylethanol testing at baseline and 3-year follow-up and complete self-report measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. RESULTS Recruitment began on September 13, 2023 and the last recruited participant was randomized on March 20, 2025. Follow-up data collection is ongoing with all 6-month follow-ups completed (86.0% retention). CONCLUSIONS This study evaluates the effectiveness and mechanisms of MBRP delivered via video conferencing, compared with referral to online mutual support groups, in supporting recovery among individuals with AUD. It also examines the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible, freely available continuing care option to support long-term recovery from AUD. CLINICALTRIAL This trial is registered on ClinicalTrials.gov under study record NCT06074341 with initial registration date of October 06, 2023.

Objective: There is a great need for the development of scalable augmentations to treatments for anorexia nervosa (AN) and bulimia nervosa (BN), as most individuals with AN/BN are currently not able to access treatment. Mindfulness‐based interventions (MBIs) may be promising for AN/BN and lend themselves well to digital delivery, increasing access. We aimed to develop and test the initial acceptability and feasibility of Mindful Courage, a digital MBI for AN/BN and atypical AN/BN. Method: We evaluated an 8‐week version of Mindful Courage including 32 modules (8 core multi‐media lessons, 24 brief audio‐guided mindfulness practices) in N = 32 participants, who also received weekly phone coaching conducted by psychology students. Ten participants (31.2%) were enrolled in outpatient ED treatment while receiving the intervention. Participants completed assessments at baseline, post‐intervention (8 weeks), and 2‐month post‐intervention follow‐up. Results: Acceptability was demonstrated by relatively high ratings for perceived usability (81.34/100), understandability (4.6/5.0), engageability (4.1/5.0), visual appeal (4.1/5.0), helpfulness (4.2/5.0), skills acquisition (4.3/5.0), and confidence applying skills (4.2/5.0). Feasibility was demonstrated by high module completion (an average of 28/32 modules). There were significant reductions in target outcomes: ED symptoms ( d = 1.21), body dissatisfaction ( d = 0.73), depression ( d = 0.76), anxiety ( d = 0.62), and clinical impairment ( d = 1.15). In addition, there were significant improvements in target mechanisms: mindfulness ( d = 0.79), emotion regulation difficulties (d = 0.65 ), and savoring beliefs ( d = 0.58). Discussion: Mindful Courage is a viable and potentially effective intervention. A future randomized‐controlled trial is warranted.

BACKGROUND Cognitive behavioral therapy (CBT) is the most effective treatment for binge eating disorder (BED) but is limited by modest efficacy and low reach of in-person delivery. Combining mindfulness training with CBT could enhance efficacy by targeting emotion dysregulation, a key factor in BED that CBT does not adequately target. Digital delivery can enhance the reach of treatment. Accordingly, we developed CBT-based Mindful Courage, a 16-session digital intervention combining CBT and mindfulness training for BED. OBJECTIVE The aim of this study is to conduct a pilot randomized controlled trial to evaluate the feasibility (intervention and assessment completion) and acceptability (usability, overall satisfaction, engagement, visual appeal of content, understandability of program content, desire to continue the program, perceived skill acquisition, perceived confidence in implementing skills, and perceived helpfulness) of CBT-based Mindful Courage. We will also evaluate changes in outcomes (binge eating frequency, eating disorder symptoms, clinical impairment, and depression symptoms) and mechanisms (emotion dysregulation, dietary overrestriction, and trait mindfulness). METHODS This is a parallel-group, single-blinded, randomized controlled trial with a 1:1 allocation ratio. It will be conducted from November 2025 to November 2026, with study assessments at baseline, midtreatment, end-of-treatment, and 2-month follow-up. We will recruit a volunteer sample of adults with BED (N=40) aged 18 to 75 years via online advertisements. Exclusion criteria include a BMI <18.5, current anorexia or bulimia nervosa, and current treatment for BED or weight loss. Participants will be randomly allocated to an active control that includes coached self-monitoring (self-monitoring of food intake in Recovery Record and coaching calls by a research assistant) or to CBT-based Mindful Courage+coached self-monitoring. Both conditions will have a duration of 18 weeks. All study sessions will take place over Zoom. RESULTS The study was funded in April 2023. Data collection began in November 2025, and we anticipate recruitment to be completed by November 2026. Results are expected to be analyzed by May 2027 and published by May 2028. CONCLUSIONS This will be an important first step in creating a scalable and efficacious treatment for BED. CLINICALTRIAL ClinicalTrials.gov NCT07212673; https://clinicaltrials.gov/study/NCT07212673 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/91761

Background and Aims: Craving, the desire to use substances, is a key factor and diagnostic criterion for substance use disorders (SUDs) that predicts substance use. Experiencing affective states, both positive (PA) and negative (NA), are also implicated in SUDs. Yet, the interrelationships among affect, craving, and substance use remain unclear, particularly at the within-person level of analysis. This study aimed to use ecological momentary assessment (EMA) to test whether craving mediates the association between PA/NA and subsequent substance use. Design: Observational study using EMA over a 14-day period and multilevel mediation models with bootstrapping. Setting: Outpatient addiction treatment centers in which participants were enrolled during the data collection period. Participants: Adults with SUDs enrolled in a pilot randomized controlled trial, evaluating an app-delivered mindfulness-based intervention for SUDs, that completed the baseline EMA period and were also randomized to a treatment condition (N=36). Measurements: Participants completed EMA surveys three times daily [midday, afternoon, evening] for 14 days, reporting on current PA, NA, craving, and substance use. We used multilevel mediation modeling to test within-person associations and examine whether craving mediated the link between affect (PA and NA) and subsequent substance use. Findings: Mediation analysis showed an indirect pathway via craving on the link between affect and substance use. Higher PA was associated with lower craving at the same EMA survey, which in turn led to reduced likelihood of substance use at the next survey (β=-0.04, p=0.02). Conversely, higher NA was associated with higher craving at the same survey, leading to greater likelihood of substance use at the next survey (β=0.08, p=0.03). Conclusion: At the within-person level, craving mediates the association between affective states and subsequent substance use in individuals with SUD. PA predicted lower craving, which in turn predicted lower likelihood of substance use, while NA predicted higher craving, which in turn predicted greater likelihood of substance use. Our findings suggest that a promising strategy may be targeting momentary affect in daily life, such as through ecological momentary interventions.