Study protocol for a randomized controlled trial of mindfulness-based relapse prevention for opioid use disorders

The opioid misuse epidemic has reached a crisis level in the United States. Though mindfulness-based relapse prevention (MBRP) has been shown as effective in treating substance use disorders, there is limited research on its application to opioid use disorders specifically, and there is a need to understand the underlying mechanisms. This paper outlines a protocol for a randomized controlled trial of MBRP for opioid use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. We will recruit 240 participants who have completed opioid use disorder treatment, and randomize them to an 8-week MBRP group intervention or treatment as usual (TAU) control group. The TAU control group will complete the intervention after 8 weeks. Assessments will take place at baseline, 8 weeks, and 16 weeks. The primary outcome is frequency of opioid use. The secondary outcomes include craving and withdrawal symptoms, time to first opioid use, adherence to medication-assisted treatment plans, perceived stress, quality of life, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators and correlates of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect. This study will contribute to the evidence base regarding MBRP's efficacy in reducing opioid use, as well as contribute to the understanding of the causal mechanisms and factors that modify treatment outcome for MBRP for substance use disorders.     

Rationale,design, and implementation of a clinical trial of a mindfulness-based relapse prevention protocol for the treatment of women with comorbid post traumatic stress disorder and substance use disorder

Comorbid post-traumatic stress disorder (PTSD) and substance use disorders (SUD) commonly co-occur and is associated with a more complex clinical presentation with poorer clinical outcomes when compared with either disorder alone, and untreated PTSD can predict relapse to substance abuse. A number of integrated treatment approaches addressing symptoms of both PTSD and SUD concurrently demonstrate that both disorders can safely and effectively be treated concurrently. However, attrition and SUD relapse rates remain high and there is need to further develop new treatment approaches. Innovative approaches such as mindfulness meditation (MM) successfully used in the treatment of SUD may offer additional benefits for individuals with SUD complicated with PTSD. Specifically, Mindfulness-based Relapse Prevention (MBRP) integrates coping skills from cognitive-behavioral relapse prevention therapy with MM practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. Here we present the design and methods for the “Mindfulness Meditation for the Treatment of Women with comorbid PTSD and SUD” study, a Stage 1b behavioral development study that modifies MBRP treatment to address both PTSD and SUD in a community setting. This study is divided into three parts: revising the existing evidence-based manual, piloting the intervention, and testing the new manual in a randomized controlled pilot trial in women with comorbid PTSD and SUD enrolled in a community-based SUD treatment program.     

Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol

BackgroundMindfulness-based interventions for healthy behaviors such as exercise and dietary modifications have aroused growing interest. This study aims to test the effectiveness of a mindfulness-based intervention for the reduction of impulsive eating and the improvement of motivation to exercise among obese individuals.MethodsOne-hundred and twenty obese outpatients, aged 18 to 65 years, diagnosed with a binge eating disorder, will be randomly assigned to one of the three following groups: mindfulness practice, sham meditation, or treatment as usual control. The tested intervention consists of a 1-year computerized mindfulness-based program. Mindfulness sessions are audio recordings that the patients are asked to listen to, 10 min every day. Self-reported questionnaires measuring impulsive eating, motivation to exercise, physical activity level, mood, and mindfulness skills are filled in at baseline, 1, 6, and 12 months. Physical activity, calories consumption, and biomarkers are measured with more objective measurement tools at baseline, 6 months and 12 months.ConclusionMindfulness, as both a de-automation element and as a moderator of motivation to exercise, can lead to the reduction of impulsive eating and also to an increase in levels of physical activity. These effects could cause weight loss in obese patients suffering from binge eating disorder.Trial registrationclinicaltrials.gov: NCT02571387.     

An interactive technology enhanced coaching intervention for Black women with hypertension: Randomized controlled trial study protocol

In the United States, hypertension (HTN) is the leading risk factor for cardiovascular disease, and a more significant health problem for Blacks compared with other racial/ethnic groups. The prevalence of HTN in Black women is among the highest in the world, underscoring the need for effective prevention and management approaches for blood pressure (BP) control. We developed a two‐arm randomized controlled trial repeated measures design study for improving HTN self‐management among Black women. The study tests whether the Chronic Disease Self‐Management Program (CDSMP) combined with interactive technology‐enhanced coaching, can improve BP control and adherence to treatment (e.g., medication‐taking, physical activity, calorie intake, and weight management) compared with the CDSMP alone. Repeated measurements were conducted at 3, 6, and 9 months. A sample of 90 community‐dwelling Black women with uncontrolled Stage 1 HTN (BP ≥ 130/80) were enrolled, completed CDSMP training, and randomized. This study will contribute to our understanding of novel methods to empower Black women to increase their active involvement in self‐care management of HTN.     

The Healthy Pregnancies Project: Study protocol and baseline characteristics for a cluster-randomized controlled trial of a community intervention to reduce tobacco use among Alaska Native pregnant women

BackgroundTobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics.DesignCluster-randomized controlled trial with village as the unit of assignment. Sixteen villages in rural southwest Alaska were stratified on village size and randomized to a multicomponent intervention (n = 8 villages) or usual care (n = 8 villages).MethodsPregnant AN women from the study villages were enrolled. All participants receive the usual care provided to pregnant women in this region. Participants from intervention villages additionally receive individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN “Native Sisters.” Baseline measurements for all enrolled pregnant women have been completed. Follow-up assessments are ongoing at delivery, and at 2 and 6 months postpartum. The primary outcome is biochemically verified tobacco use status at 6 months postpartum.ResultsRecruitment was feasible with 73% of eligible women screened enrolled. The program reached more than half (56%) of AN pregnant women from the study villages during the recruitment period. Participants are N = 352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages. At baseline, participants' mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users.DiscussionProcesses and products from this project may have relevance to other Native American populations aiming to focus on healthy pregnancies in their communities.     

Methods and rationale to assess the efficacy of a parenting intervention targeting diet improvement and substance use prevention among Latinx adolescents

Latinx adolescents are at higher risk for chronic diseases relative to adolescents of other ethnic groups, in part because of their lack of adherence to diet recommendations and their higher rates of substance use. Given the proximal influence of family factors during the developmental stage of adolescence, parenting interventions may be an effective way to promote healthy nutrition and substance use prevention simultaneously. This article describes the design and theoretical rationale of a study assessing the effects of Families Preparing the New Generation Plus (FPNG Plus), a 10-week culturally-tailored nutrition and substance use prevention parenting program, on diet and substance use outcomes among Latinx middle school students (6th–8th grade). The 3-arm cluster randomized controlled trial compares FPNG Plus (substance use prevention and healthy nutrition), FPNG (substance use prevention only), and a comparison condition (focusing on academic success) in 1494 parent-child dyads from 18 schools, randomized at the school level. Adolescents and parents will complete surveys pre- and post-intervention, and 16-weeks after program participation, regarding diet behaviors, substance use, and parenting practices. A random subsample of 126 dyads (42 from each program), will participate in additional data collection to assess the home food environment, detailed dietary intake (via two 24-h recalls), and provide biomarkers of cardiometabolic risk (blood pressure, total cholesterol and HbA1c). If successful, this study will provide evidence contributing to helping Latinx parents assist their adolescent children develop and maintain long-lasting positive lifestyle behaviors in order to prevent concurrent substance use and diet-related chronic diseases.     

Acupuncture as a complex intervention for depression: a consensus method to develop a standardised treatment protocol for a randomised controlled trial

OBJECTIVE: To standardise a complex intervention by defining the characteristic (specific) components of treatment for a randomised controlled trial of acupuncture as an intervention for individuals who have been diagnosed with depression using a consensus method. METHODS: A nominal group technique was used. Potential components of the acupuncture intervention were generated from the literature, experts and participants. These were categorised as constant or variable, the latter including active management techniques (such as providing relevant explanations), auxiliary techniques (such as auricular acupuncture), and other aspects of patient care (such as offering life-style and dietary advice), all of which were underpinned by defined theoretical frameworks. Participants were selected on the basis of their experience and training, to encompass a diverse range of styles of traditional acupuncture practice in the UK, and all rated components in two rounds. RESULTS: Fifteen practitioners rated 52 variable components in the first round and 55 in the second. There was group support for 16 active management components, three auxiliary techniques and five areas of life-style support, all driven by eight theoretical diagnostic and treatment frameworks. For the 39 components that were rated twice, group support increased between rounds from 75 to 79% (z=-2.2, p=0.03), while the absolute average deviation from the median dropped from 1.04 to 0.83 (z=-2.5, p=0.011). CONCLUSION: Standardising the characteristic components of a complex intervention for a randomised controlled trial of acupuncture for depression using a consensus approach is feasible. The method can be generalised to other clinical situations and other treatment modalities.     

Reducing sexual health risks and substance use in the prenatal setting: A study protocol for a randomized controlled trial

Sexually transmitted infections (STIs) are at a record high in the United States, and STI risk is a critical and costly public health concern for childbearing women. STIs can lead to a number of serious health risks including premature birth, low birth weight, ectopic pregnancy, and fetal death. Similarly, there has been a dramatic increase in substance use during pregnancy, leading to complications during pregnancy and poorer birth outcomes. Women who misuse substances are disproportionately more likely to engage in risky sexual behaviors that can result in STIs. The proposed study will test whether the Health Check-Up for Expectant Moms (HCEM), a computer-delivered brief intervention that simultaneously targets STI risk and alcohol/illicit drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care. The study is a two-group, randomized controlled trial in which a diverse sample of 250 pregnant women will be recruited from prenatal care clinics and assigned to either (a) a computer-delivered, single-session brief intervention plus two booster sessions); or (b) a computer-delivered control condition. Follow-up assessments will occur at 2 and 6 months from baseline, and at 6 weeks postpartum. Our objective measures include STI incidence and birth outcomes. The results of this trial will fill a critical gap and provide much-needed data on the efficacy, costs, and resource utilization of a practical computer-delivered, brief motivational intervention tailored to reach high-risk women during pregnancy and extending impact to postpartum.     

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial

ObjectiveThis study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery.DesignRandomized, controlled pilot trial.SettingBeth Israel Deaconess Medical Center, Boston, MA, USA.InterventionsBariatric patients 1–5 years post-surgery (n = 18) were randomized to receive a 10-week MBI or a standard intervention.Main outcome measuresPrimary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted.ResultsAttendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (−4.9 ± 13.7 in mindfulness vs. 6.2 ± 28.4 in standard, p for between-group difference = 0.03) but not weight. We also observed a significant increase in HbA1C (0.34 ± 0.38 vs. −0.06 ± 0.31, p = 0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews.ConclusionsThis novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population.Clinical trial registrationClinicalTrials.gov identifier NCT02603601.     

Rationale for a new direction in foster youth substance use disorder prevention

Background: Of the 463 000 children residing in United States foster care, 29 000 annually exit the system because they have “aged out,” are thus dropped from supportive services, and become responsible for their own housing, finances and health needs. Given histories of maltreatment, housing instability and parental substance use, youth preparing to exit care are at substantial risk of developing substance use disorders. Unfortunately, access to services is often limited, both before and after exit from care. Methods: With the goal of developing a relevant substance use intervention for these youth, focus groups were conducted with foster care staff, administrators and parents to assess the feasibility of potential approaches. Results: Participants identified several population-specific barriers to delivering adapted intervention models developed for normative populations. They expressed concerns about foster youth developing, then quickly ending, relationships with interventionists, as well as admitting to substance use, given foster care program sanctions for such behavior. Group members stressed the importance of tailoring interventions, using creative, motivational procedures. Conclusions: Foster youth seem to encounter unique barriers to receiving adequate care. In light of these results, a novel, engaging approach to overcoming these barriers is also presented.     

Pilates for low risk pregnant women: Study protocol for a randomized controlled trial

BackgroundPilates has growing appeal to pregnant women, as a form of exercise and relaxation. It is purported to benefit lumbo-pelvic stability, as well as motor control, strength and endurance. Some suggest that modified Pilates exercises may assist low risk pregnant women to enjoy a healthier pregnancy and prepare for the physical demands of labour and birth. The feasibility and safety of Pilates during pregnancy is poorly understood. We describe the protocol for a feasibility study designed to compare a midwife-led 6-week community-based Pilates intervention with standard antenatal care.MethodsA convenience sample of 30 low-risk pregnant women will be recruited from private obstetric clinics in Melbourne, Australia. Participants shall be randomly allocated to a six-week, 1-h weekly Pilates exercises group session or to usual care. The Pilates exercise class will have a warm-up phase, Pilates exercises, breathing exercises, and a cool down phase. Exercises have been designed to prepare for active birth. The primary outcome will be feasibility of implementation, determined by recruitment, retention, adherence and safety. Secondary outcomes include women's health (quality of life, pain, mobility for daily activities, lower extremity performance, abdominal separation, continence) and labour and birth outcomes (duration of first stage and second stage labour, analgesia used, mode of birth). Validated questionnaires will include the Quality of life 12-item short form survey; Pregnancy Mobility Index, and International Consultation on Incontinence Questionnaire. Lower extremity performance and abdominal separation will also be measured.DiscussionThis trial will provide preliminary data regarding the feasibility and safety of Pilates exercise in healthy pregnant women. It will also provide preliminary outcome data used to inform the design of a future large scale, multi-centre RCT.Trial registrationThis clinical trial has been registered with the Australian and New Zealand Clinical Trials Registry 2016 (ACTRN12616000809437).     

Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial

Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness. This study is a parallel groups (two-arm) single-blind randomized controlled trial. A minimum of 96 patients with SAD will be recruited within a public outpatient community mental health clinic in Perth, Australia. The primary outcomes will be self-reported symptom severity, caseness (SAD present: yes/no) based on a structured diagnostic interview, and clinician-rated severity and life impact. Secondary outcomes and mechanism measures include blind observer-rated use of safety behaviors, physiological activity (heart rate variability and skin conductance level) during a standardized speech task, negative self-beliefs, imagery suppression, fear of negative and positive evaluation, repetitive negative thinking, anxiety, depression, self-consciousness, use of safety behaviors, and the EQ-5D-5L and TiC-P for the health economic analysis. Homework completion, group cohesion, and working alliance will also be monitored. The outcomes of this trial will inform clinicians as to whether integrating imagery-based strategies in cognitive behavior therapy for SAD is likely to improve outcomes. Common and distinct mechanisms of change might be identified, along with relative cost-effectiveness of each intervention.     

Effectiveness of adjunctive,personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial

IntroductionOpioid use disorder (OUD) is a debilitating and relapsing psychiatric disorder; opioid agonist therapy (OAT) is the front-line, evidence-supported treatment. A substantial number of patients relapse or continue to use heroin or other illicit drugs during OAT. There is considerable heterogeneity in the OAT-resistant sub-population, with many behavioural moderators of treatment response. We have developed a personalised psychosocial intervention (PSI) targeting these individuals. A formulation-guided assessment is linked to a toolkit of motivational, cognitive/behavioural and social support techniques. Change methods have been adapted from evidence-supported psychological therapies and are idiosyncratically tailored to the need and response.MethodsIn this single-centre, 18-week, parallel group, pragmatic randomised clinical trial, we will determine the clinical and cost-effectiveness of the PSI as an adjunctive intervention during OAT, in comparison to opioid agonist treatment-as-usual. We plan to recruit 368 adults. The primary outcome measure is the proportion of participants categorised as ‘responders’ at the end of the intervention (defined as self-reported abstinence from heroin and cocaine with no positive biological drug tests during the 28 days prior to the endpoint). Secondary outcomes include: percentage of days abstinent from heroin and cocaine in the 28 days before follow-up; treatment retention; therapy compliance; health and social functioning; exploratory genetic biomarkers; and analyses of treatment moderation and mediation.ConclusionsThis pragmatic controlled trial determines the effectiveness and cost-effectiveness of a personalised PSI for non-responding patients during OAT. Our intervention applies motivational, cognitive/behavioural and social support techniques adapted from evidence-based therapies. Findings will inform stratified delivery of OAT.     

Promoting physical activity among women with mobility impairments: a randomized controlled trial to assess a home- and community-based intervention

OBJECTIVE: To assess the effectiveness of an intervention to promote physical activity and fitness in physically disabled women. DESIGN: Randomized controlled trial. SETTING: Home or community. PARTICIPANTS: Seventy-five adult women with mobility limitations. INTERVENTION: Incorporated behavioral techniques, social support, and education to promote exercise. MAIN OUTCOME MEASURES: Fitness measures included weight, body mass index, resting blood pressure and heart rate, time to complete a mobility course, and heart rate during and blood pressure after navigating the course. Also collected self-reported experience of secondary conditions and weekly self-reports of physical activity. RESULTS: We found no significant fitness differences between groups, except for peak heart rate. However, paired t tests of the physical activity data revealed the experimental group significantly increased its total weekly physical activity minutes (P=.04), and the increase in weekly cardiovascular activity approached significance (P=.06). CONCLUSIONS: The experimental group did not experience better fitness or fewer secondary conditions than the controls. However, the experimental group's physical activity data indicate that this group significantly increased its activity over 6 months. Thus, although this study did not detect health changes, it showed that mobility-impaired women can adopt and maintain a physical activity program.     

Effectiveness of psychosocial intervention for internalizing behavior problems among children of parents with alcohol dependence: Randomized controlled trial

BACKGROUNDParental drinking has a direct bearing on children. Behavioral problems such as anxiety and depression are common problems among children whose parents drink heavily. Psychosocial interventions have shown promising results for anxiety and depression among children; however, few studies have been conducted in the context of children of parents with alcohol dependence in India.AIMTo evaluate the efficacy of psychosocial intervention for internalizing behavioral problems among children of parents with alcohol dependence.METHODSA randomized controlled trial with a 2 × 4 factorial design was adopted with longitudinal measurement of outcomes for 6 mo. Two-hundred and eleven children who met the eligibility criteria (at least one parent with alcohol dependence) at government high schools in Bangalore, India, were randomized to the experimental (n = 97) or control group (n = 98). The psychosocial intervention was administered to the experimental group in eight sessions (biweekly) over 4 wk after baseline assessment. The intervention focused on identifying and modifying negative thoughts, replacing thinking errors with realistic alternatives, modification of maladaptive behavior, developing adaptive coping skills and building self-esteem. The data was collected pre-intervention and at 1, 3 and 6 mo after the intervention. Data were analyzed using SPSS 28.0 version. RESULTSMean age of the children was 14.68 ± 0.58 years, 60.5% were male, 56% were studying in 9th standard, 70.75% were from nuclear families, and mean family monthly income was 9588.1 ± 3135.2 INR. Mean duration of parental alcohol dependence was 7.52 ± 2.94 years and the father was the alcohol-consuming parent. The findings showed that there were significant psychosocial intervention effects in terms of decreasing anxiety and depression scores, and increasing self-esteem level among experimental group subjects over the 6-mo interval, when compared with the control group (P < 0.001). CONCLUSIONThe present study demonstrated that the psychosocial intervention was effective in reducing anxiety and depression, and increasing self-esteem among children of parents with alcohol dependence. The study recommends the need for ongoing psychosocial intervention for these children.     

YMCA exercise intervention to augment smoking cessation treatment in adults with high anxiety sensitivity: Study protocol for a randomized controlled trial

Extant evidence suggests that exercise can reduce anxiety related vulnerability factors, such as anxiety sensitivity (AS), or fear of bodily sensations related to anxiety, that negatively impact smoking cessation outcomes. Building upon emerging evidence supporting the efficacy of exercise as an aid for smoking cessation in adults with high AS, we are conducting a trial to examine the efficacy and feasibility of this clinical application when implemented in a community setting. Partnering with the YMCA, this study aims to enroll 150 adults in a standard smoking cessation protocol (i.e. counseling and nicotine replacement therapy) and randomly assign them to either 15 weeks of programmed vigorous-intensity or low-intensity exercise. Smoking abstinence data will be collected up to 6 months following the quit attempt.     

Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV

PurposeBy 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.MethodsThis randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.ConclusionThis is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV.ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.     

Randomized controlled trial of the COPE-P intervention to improve mental health,healthy lifestyle behaviors,birth and post-natal outcomes of minority pregnant women: Study protocol with implications

BackgroundEmotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low birth weight. Although the United States Preventive Services Task Force recommends screening in pregnant women, many practices do not screen because efficacious interventions and systems are not in place to treat them. Aim: Purpose of this randomized controlled trial (RCT) is to test a group delivered manualized cognitive-behavioral skills building intervention entitled COPE-P versus an attention control program on the mental health, birth and postpartum outcomes of minority pregnant women experiencing depressive, anxiety and stress symptoms. Methods: Design is a longitudinal randomized block RCT with repeated measures (beginning with screening prior to 18 weeks, group prenatal care in both groups from 16 + 1 to 31 + 1 weeks and ending at 6 months postpartum) at two study sites (New York city and Columbus, Ohio). Race/ethnicity is being blocked to ensure equal numbers of Hispanic and Black women. 384 women are being recruited from antenatal clinics if they are: between 18 and 40 years; in an uncomplicated singleton pregnancy <18 weeks; and self-identify as Black or Hispanic. Valid and reliable measures are being used to assess healthy lifestyle behaviors and mental health outcomes immediately following the interventions, six - eight weeks postpartum and at the children's six-month well baby visit. Birth and delivery outcomes also are being assessed. Conclusion: If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their outcomes.