Mindfulness based intervention with an attentional comparison group in at risk young adolescents: a pilot randomized controlled trial.
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ABSTRACT:
SUBMITTER: Rawlett KE
PROVIDER: S-EPMC6527909 | biostudies-other | 2019 Jun
REPOSITORIES: biostudies-other
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Mindfulness based intervention with an attentional comparison group in at risk young adolescents: a pilot randomized controlled trial.
Rawlett Kristen E KE Friedmann Erika E Thomas Sue A SA
Integrative medicine research 20190412 2
<h4>Background</h4>Risky behaviors are related to poor outcomes among young adolescents. This study piloted a mindfulness based intervention, Learning 2 Breath Mindfulness Curriculum, focusing on the feasibility of programming and intervention effects on coping, affect, and trait mindfulness among at-risk adolescents. Further, the mindfulness based intervention was compared to an attention intervention.<h4>Methods</h4>Sixth-grade level female students in a boarding school for at-risk youth rando ...[more]
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Project description:OBJECTIVES:To assess feasibility/acceptability of a mindfulness-based approach to excess weight prevention in adolescents at-risk for excess weight gain. To pilot test efficacy of a mindfulness-based intervention for improving food reward sensitivity, stress-eating, executive function (EF), and BMI/adiposity. METHODS:A pilot randomized controlled trial was conducted with 12-17y adolescents at-risk for excess weight gain based on above-average weight (body mass index [BMI]?70%ile) or parental history of obesity (BMI?30?kg/m2). Adolescents were randomized to a mindfulness-based (n?=?29) or health education control group (n?=?25) that met for six weekly one-hour sessions. Feasibility/acceptability were determined from attendance and acceptability survey ratings. At baseline, six-week and six-month follow-up, adolescents' perceived stress was measured with the Perceived Stress Scale, food reward sensitivity with a behavioral task, stress-eating during a laboratory test meal, and EF with the parent-reported Behavior Rating Inventory of Executive Function and NIH Toolbox. At the same intervals, BMI indices and body fat by air displacement plethysmography were assessed in a fasted state. RESULTS:Median session attendance was 6:6 sessions in both conditions; program acceptability ratings were above-average. Compared to health education, adolescents in mindfulness had lower food reward sensitivity at six-months (Cohen's d?=?0.64, p?=?.01). There were no between-condition differences in BMI (mindfulness vs. health education?six-months 95%CI 0.20, 1.52?kg/m2 vs. 0.21, 1.62?kg/m2) or adiposity (-3.64, -0.61% vs. -4.31, -1.04%) changes. CONCLUSIONS:A mindfulness-based group intervention is feasible/acceptable among adolescents at-risk for excess weight. In this pilot sample, mindfulness and health education were equivocal for BMI/adiposity outcomes. Future trials with a larger, adequately-powered sample and longer-term follow-up are necessary to test efficacy of a mindfulness-based intervention for food reward sensitivity, stress-eating, EF, and stabilizing growth trajectories in youth at-risk for adult obesity.
| S-EPMC6585452 | biostudies-literature
Project description:BACKGROUND:Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. OBJECTIVES:The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI's ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. METHODS:Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants' own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance, perceived stress, and mindfulness were completed before and after the intervention period via Web-based surveys. RESULTS:We enrolled 44 adults were enrolled and 31 adults completed all study activities. There were no group differences on demographics or important variables at baseline. Participants rated the IMMI arm higher than the Access to Guided Meditation arm on Client Satisfaction Questionnaire. IMMI was able to increase home practice behavior significantly compared to the Access to Guided Meditation arm: days practiced (P=.05), total minutes (P=.01), and average minutes (P=.05). As expected, there were no significant differences on health outcomes. CONCLUSIONS:In conclusion, IMMI was found to be feasible and acceptable. The IMMI arm had increased daily meditation practice compared with the Access to Guided Meditation control group. More interaction through staff and/or through built-in email or text reminders may increase daily practice even more. Future studies will examine IMMI's efficacy at improving health outcomes in the general population and also compare it directly to the well-studied mindfulness-based group interventions to evaluate relative efficacy. TRIAL REGISTRATION:Clinicaltrials.gov NCT02655835; http://clinicaltrials.gov/ct2/show/NCT02655835 (Archived by WebCite at http://www.webcitation/ 6jUDuQsG2).
| S-EPMC4993863 | biostudies-literature
Project description:OBJECTIVE:(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. DESIGN AND SETTING:Parallel-group, randomized controlled pilot trial conducted at a university. PARTICIPANTS:Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). INTERVENTIONS:Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. MAIN OUTCOME MEASURES:Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. RESULTS:Most adolescents attended ?80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). CONCLUSIONS:A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138 clinicaltrials.gov.
| S-EPMC5705100 | biostudies-literature
Project description:BACKGROUND:Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. OBJECTIVE:In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants' antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. METHODS:In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. RESULTS:Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants' perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). CONCLUSIONS:The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants' daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention's mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. TRIAL REGISTRATION:ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596.
| S-EPMC7455868 | biostudies-literature
Project description:BackgroundBetween 15% and 70% of adolescents report experiencing cybervictimization. Cybervictimization is associated with multiple negative consequences, including depressed mood. Few validated, easily disseminated interventions exist to prevent cybervictimization and its consequences. With over 97% of adolescents using social media (such as YouTube, Facebook, Instagram, or Snapchat), recruiting and delivering a prevention intervention through social media and apps may improve accessibility of prevention tools for at-risk youth.ObjectiveThis study aims to evaluate the feasibility and acceptability of and obtain preliminary outcome data on IMPACT (Intervention Media to Prevent Adolescent Cyber-Conflict Through Technology), a brief, remote app-based intervention to prevent and reduce the effect of cyberbullying.MethodsFrom January 30, 2020, to May 3, 2020, a national sample of 80 adolescents with a history of past-year cybervictimization was recruited through Instagram for a randomized control trial of IMPACT, a brief, remote research assistant-led intervention and a fully automated app-based program, versus enhanced web-based resources (control). Feasibility and acceptability were measured by consent, daily use, and validated surveys. Although not powered for efficacy, outcomes (victimization, bystander self-efficacy, and well-being) were measured using validated measures at 8 and 16 weeks and evaluated using a series of longitudinal mixed models.ResultsRegarding feasibility, 24.5% (121/494) of eligible participants provided contact information; of these, 69.4% (84/121) completed full enrollment procedures. Of the participants enrolled, 45% (36/80) were randomized into the IMPACT intervention and 55% (44/80) into the enhanced web-based resources groups. All participants randomized to the intervention condition completed the remote intervention session, and 89% (77/80) of the daily prompts were answered. The retention rate was 99% (79/80) at 8 weeks and 96% (77/80) at 16 weeks for all participants. Regarding acceptability, 100% (36/36) of the intervention participants were at least moderately satisfied with IMPACT overall, and 92% (33/36) of the participants were at least moderately satisfied with the app. At both 8 and 16 weeks, well-being was significantly higher (β=1.17, SE 0.87, P=.02 at 8 weeks and β=3.24, SE 0.95, P<.001 at 16 weeks) and psychological stress was lower (β=-.66, SE 0.08, P=.04 at 8 weeks and β=-.89, SE 0.09, P<.001 at 16 weeks) among IMPACT users than among control group users. Participants in the intervention group attempted significantly more bystander interventions than those in the control group at 8 weeks (β=.82, SE 0.42; P=.02).ConclusionsThis remote app-based intervention for victims of cyberbullying was feasible and acceptable, increased overall well-being and bystander interventions, and decreased psychological stress. Our findings are especially noteworthy given that the trial took place during the COVID-19 pandemic. The use of Instagram to recruit adolescents can be a successful strategy for identifying and intervening with those at the highest risk of cybervictimization.Trial registrationClinicalTrials.gov NCT04259216; http://clinicaltrials.gov/ct2/show/NCT04259216.
| S-EPMC8482167 | biostudies-literature
Project description:BackgroundPersistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups.MethodsA sample of 73 adolescents aged 16-19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with PainTM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS.ResultsDemographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen's d = .9) for depression suggested a lower depression score in the intervention group.ConclusionsHigh treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention.Trial registrationThe iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977 ). Registered 6 June 2018.
| S-EPMC9327289 | biostudies-literature
Project description:BACKGROUND:Eight-week mindfulness-based interventions (MBIs) have a beneficial impact on mental health and well-being in adolescents with chronic health conditions. Usually delivered in person in a group setting, these programs are difficult to access for teens with disabilities or who do not have in-person MBIs available in their communities. OBJECTIVE:This paper outlines the rationale, development, and design of a randomized controlled trial comparing the effects of an MBI delivered in person or via eHealth in adolescents with a chronic illness. Quantitative outcomes will include mindfulness skills acquisition (primary outcome), effects of the MBI on self-reported mood, anxiety, self-esteem, illness perception, and physiological stress (via salivary cortisol), and qualitative outcomes will include individual practice, participant appreciation, and adaptation of the MBI for eHealth. METHODS:This is a randomized noninferiority mixed methods study comparing 2 MBI arms: in-person and eHealth. Participants are eligible to participate if they are aged 13 to 18 years, have a diagnosis of chronic medical condition, live close enough to the recruitment hospital to participate in the in-person arm of the study, and are currently followed by a health care provider. Each participant will receive an adapted 8-week MBI delivered either in person at a tertiary pediatric hospital or via a secure audio-visual platform allowing group interactions in real time. Groups will be facilitated by 2 experienced mindfulness providers. Quantitative and qualitative data will be collected through standardized research questionnaires administered via a secure, youth-friendly online platform and through semistructured interviews, participant log books, facilitator log books, and salivary cortisol analysis. Qualitative data will be analyzed using a grounded theory model. RESULTS:Data collection is currently underway. Data analysis, manuscript writing, and additional publications are expected to be completed in the winter and spring of 2018. CONCLUSIONS:Based on previous results from in-person trials conducted in adolescents and eHealth trials conducted in adults, we anticipate that both modes of delivery will significantly improve mindfulness skills acquisition, mood, anxiety, self-esteem, illness perception, and stress and that the magnitude of the effects will be correlated to the level of home practice. We predict that participants in both arms will show similar levels of home practice and that both modes of delivery will have high levels of feasibility and acceptability. If successful, this study could provide evidence for the use of eHealth in the delivery of 8-week MBIs in clinical adolescent populations, potentially increasing availability to MBIs for a large group of youth with mobility issues or living away from large urban centers. TRIAL REGISTRATION:ClinicalTrials.org NCT03067207; https://clinicaltrials.gov/ct2/show/NCT03067207 (archived by WebCite at http://www.webcitation.org/6v4ZK8RBH).
| S-EPMC5725624 | biostudies-literature
Project description:BackgroundTwo strategies of the US Ending the HIV Epidemic initiative are early diagnosis of infections via widespread testing and prevention of new infections using pre-exposure prophylaxis (PrEP). These strategies are particularly important for adolescents and young adults (AYAs) who are disproportionately affected by HIV, particularly if they identify as Black and/or lesbian, gay, bisexual, transgender, queer or questioning, and others (LGBTQ+). This study will develop and test an interactive life-simulation game in which players can enact real-life behaviors and receive their HIV risk profile to improve HIV testing and PrEP access among AYAs aged 13-24 years in Washington, DC.ObjectiveThis mixed methods study aims to determine the acceptability of an interactive, enhanced life-simulation game prototype among AYAs, conduct a pilot test of the gaming intervention among a small cohort of AYAs to ensure game usability and acceptability, and evaluate the efficacy of the game in a randomized controlled study with AYAs at risk for HIV in Washington, DC.MethodsThis research protocol will be conducted in 3 phases. A formative phase will involve surveys and focus groups (n=64) with AYAs living in the DC area. These focus groups will allow researchers to understand youth preferences for game enhancement. The second phase will consist of a pilot test (n=10) of the gaming intervention. This pilot test will allow researchers to modify the game based on formative results and test the planned recruitment and data collection strategy with intended end users. The third phase will consist of a randomized controlled study among 300 AYAs to examine the efficacy of the life-simulation game compared with app-based HIV educational materials on HIV and PrEP in changing HIV testing, knowledge, risk behaviors, and PrEP access. Participants will have unlimited access to either the life-simulation game or the educational app for 3 months from the time of enrollment. Study assessments will occur at enrollment and at 1, 3, and 6 months post enrollment via e-surveys. At 6 months, a subset of intervention participants (n=25) will participate in in-depth exit interviews regarding their experience being in the study.ResultsInstitutional review board approval was received on February 5, 2020. This project is currently recruiting participants for the formative phase.ConclusionsThis interactive life-simulation intervention aims to increase HIV testing and PrEP access among AYAs in the DC area. In this intervention, players can enact real-life behaviors and receive their HIV risk profile to promote HIV testing and PrEP seeking. Such an intervention has great potential to improve knowledge of HIV and PrEP among AYAs, increase motivation and self-efficacy related to HIV testing and PrEP use, and decrease individual and structural barriers that often preclude engagement in HIV prevention services.Trial registrationClinicalTrials.gov NCT04917575; https://clinicaltrials.gov/ct2/show/NCT04917575.International registered report identifier (irrid)PRR1-10.2196/29792.
| S-EPMC8277397 | biostudies-literature
Project description:This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery.Randomized, controlled pilot trial.Beth Israel Deaconess Medical Center, Boston, MA, USA.Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention.Primary 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.Attendance 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.This 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.ClinicalTrials.gov identifier NCT02603601.
| S-EPMC5043638 | biostudies-literature
Project description:We report results of a pilot study designed to test a novel smoking cessation intervention, Mindfulness Training for Smokers (MTS), in smokers age 18-29 years with regular episodes of binge drinking. Mindfulness is a cognitive skill of applying close moment-to-moment attention to experience with a mental posture of acceptance and non-reactivity. The MTS intervention consisted of six weekly classes that provided instruction on how to use mindfulness to manage known precursors of smoking relapse including smoking triggers, strong emotions, stressful situations, addictive thoughts, urges, and withdrawal symptoms.The MTS intervention was compared to Interactive Learning for Smokers (ILS), a time/intensity matched control group using daily non-directed walking instead of mindfulness meditation. Recruitment was conducted primarily at local technical colleges. Primary outcome measures included biochemically-confirmed smoking abstinence and reduction in alcohol use at the end of treatment (2-weeks post-quit attempt).The sample (N = 55) was 70.9% male, with a mean age of 21.9 years, and a mean of 11.76 alcoholic drinks consumed per week. Intent-to-treat analysis showed biochemically-confirmed 7-day point prevalence abstinence rates at 2-weeks post-quit for MTS = 20.0% and ILS = 4.0%, p = .08. Secondary analysis showed number of drinks per week in the first 2-weeks post-quit correlated with smoking relapse at 2-weeks post-quit (p?<?.01).This pilot study demonstrated that Mindfulness Training for Smokers shows promise for smoking cessation and alcohol use reduction in treating young adult smokers with alcohol abuse. Results suggest the need for a study with larger sample size and methods that reduce attrition.ClnicalTrial.gov, NCT01679236.
| S-EPMC3847085 | biostudies-literature