Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial.

BACKGROUND: Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. OBJECTIVE: This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. METHODS: This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. RESULTS: Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. CONCLUSIONS: The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48898.

Maximizing the Potential of Mini-Grants to Promote Policy, Systems, and Environmental Changes: Outcomes and Challenges.

PURPOSE AND OBJECTIVES: This article describes the implementation and evaluation of a chronic disease mini-grant initiative, coordinated by a state health department in collaboration with multiple stakeholders. Braided funding from federal and state sources was used to build and implement the initiative. INTERVENTION APPROACH: Mini-grants, facilitated by five different facilitating organizations, were funded to promote implementation of policy, systems, and environmental (PSE) changes at the local level. Grant recipients represented a variety of sectors, including education, government, and nonprofit organizations. EVALUATION METHODS: Primary (surveys) and secondary (final reports) data documented achievement of PSE changes. RESULTS: A total of $196,369 was dispersed to 65 organizations; 126 PSE changes in the areas of physical activity, nutrition, and tobacco were reported. Challenges in implementing and evaluating mini-grants were identified, including the heterogeneity of the sectors/settings involved and associated variability of proposed activities, time lines, measurement, and evaluation activities. COVID-19 (coronavirus disease 2019) also disrupted the plans for many projects. IMPLICATIONS FOR PUBLIC HEALTH: The success of this initiative can be attributed to four main elements: (1) the use of intermediary organizations to facilitate the mini-grants; (2) a participatory evaluation process, combined with early and ongoing communication among all stakeholders; (3) a braided funding strategy; and (4) a multisector approach that engaged both traditional and nontraditional public health organizations. The processes and outcomes, including challenges, can inform other state health departments' efforts in braiding funding and engaging intermediary organizations to expand the reach of PSE changes at the local level.

Feasibility and Acceptability of Guided Imagery to Sequentially Address Multiple Health Behaviors During Pregnancy.

INTRODUCTION: Pregnancy presents health challenges related to well-being, physical activity, dietary regulation, and body image. There is evidence to support the use of guided imagery to address these concerns during pregnancy. The purpose of this study was to analyze the use and short-term outcomes of a multiple-behavior guided imagery intervention delivered through a mobile health (mHealth) application for pregnant women. METHODS: A single-arm, 5-week feasibility trial was conducted, and participants were instructed to listen to an audio file every day for 35 days on an mHealth application. Measurements included ongoing assessments of the participants' use of the guided imagery audio files and pre- and post-test measures of depression, anxiety, stress, physical activity, food cravings, and body image. Postintervention qualitative interviews were conducted to assess whether participants would continue to use guided imagery. RESULTS: Fifty-eight participants (mean age, 28.5 years) were enrolled from January to June of 2018. Cloud analytics data showed an average of 4.96 audio downloads per week with the Sleep and Relaxation file being the most widely used (mean weekly usage, 5.67) and reported favorite during follow-up interviews. Paired-sample t tests from pre- to post-test showed significant reductions in depression, anxiety, and stress, increased physical activity, and sedentary behavior along with some changes in body image. DISCUSSION: Future scalable guided imagery interventions are justified to test for efficacy. Guided imagery may also be delivered in person by health care providers or by using widely available technologies.

A telephone-based guided imagery tobacco cessation intervention: results of a randomized feasibility trial.

BACKGROUND: Evidence supports the use of guided imagery for smoking cessation; however, scalable delivery methods are needed to make it a viable approach. Telephone-based tobacco quitlines are a standard of care, but reach is limited. Adding guided imagery to quitline services might increase reach by offering an alternative approach. PURPOSE: To develop and test the feasibility and potential impact of a guided imagery-based tobacco cessation intervention delivered using a quitline model. METHODS: Participants for this randomized feasibility trial were recruited statewide through a quitline or community-based methods. Participants were randomized to guided imagery Intervention Condition (IC) or active behavioral Control Condition (CC). After withdrawals, there were 105 participants (IC = 56; CC = 49). The IC consisted of six sessions in which participants created guided imagery audio files. The CC used a standard six-session behavioral protocol. Feasibility measures included recruitment rate, retention, and adherence to treatment. We also assessed 6-month quit rates and consumer satisfaction. RESULTS: Both the IC and CC protocols were feasible to deliver. We finalized protocols and materials for participants, coaches and study staff, and delivered the protocols with fidelity. We developed successful recruitment methods, and experienced high retention (6 months = 81.9%) and adherence (all sessions = 66.7%). Long-term quit rates (IC = 27.9%; CC = 38.1%) compared favorably to those of quitlines, and program satisfaction was high, suggesting that the protocols are acceptable to smokers and may contribute to smoking abstinence. CONCLUSIONS: The guided imagery intervention is feasible and promising, suggesting that a fully powered RCT to test the efficacy of the intervention is warranted. TRIAL REGISTRATION NUMBER: NCT02968381.

Developing a Guided Imagery Telephone-Based Tobacco Cessation Program for a Randomized Controlled Trial.

BACKGROUND/AIMS: Guided imagery is an evidence-based, multi-sensory, cognitive process that can be used to increase motivation and achieve a desired behavior. Quitlines are effective, standard care approaches for tobacco cessation; however, utilization of quitlines is low. Using guided imagery-based interventions for smoking cessation may appeal to smokers who do not utilize traditional quitline services. This paper reports the development of program materials for a randomized controlled feasibility trial of a guided imagery-based smoking cessation intervention. The objective of the formative work was to ensure that program materials are inclusive of groups that are less likely to use quitlines, including men and racial/ethnic minority tobacco users. METHODS: A three-phase process was used to complete formative assessment: (1) integration of evidence-based cessation practices into program development; (2) iterative small group interviews (N = 46) to modify the program; and (3) pilot-testing the coaching protocol and study process among a small sample of smokers (N = 5). RESULTS: The Community Advisory Board and project consultants offered input on program content and study recruitment based on their knowledge of minority communities with whom they conduct outreach. Small group interview participants included members of underserved quitline populations (52.37% non-white; 55.56% men). Only 28.26% of participants had prior experience with guided imagery, but others described the use of similar mindfulness and meditation practices. Participant feedback was incorporated into program materials and protocols. DISCUSSION: Iteratively collected feedback and pilot testing influenced program content and delivery and informed study processes for a randomized controlled feasibility trial of a telephone-delivered, guided imagery-based intervention.

Testing the feasibility of a guided imagery tobacco cessation intervention delivered by a telephone quitline: Study protocol for a randomized controlled feasibility trial.

BACKGROUND: Guided imagery (GI) is an evidence-based method that uses the imagination to practice and achieve a desired outcome. Little research has focused on how GI can be delivered to smokers using remote or virtual methods, such as a telephone-based intervention. Telephone-based services for tobacco cessation (quitlines) have emerged as standard of care for tobacco cessation. However, quitlines reach only a small fraction of smokers, and men and racial/ethnic minorities are less likely to use quitlines than majority women. GI has the potential to attract under-served minority groups as well as smokers who are looking for an alternative approach to cessation. The present study is designed to test the feasibility and potential impact of a GI tobacco cessation intervention delivered by telephone. This study compares the GI intervention with a standard behavioral (SB) intervention. METHODS: Participants (N = 100) are randomized to either the GI (intervention) or SB (control) condition. Each condition features a 6-week intervention in which participants work with coaches to quit tobacco. Primary outcomes are feasibility related (recruitment, retention, adherence), and secondary outcomes include cessation at 6 months post-intervention (7-day and 30-day abstinence). DISCUSSION: A GI intervention delivered via quitline would allow for scalability and dissemination, potentially reaching a more representative group of smokers. Results from this study will determine the feasibility of delivering the GI intervention, and describe the reach of the intervention to under-represented tobacco users. If successful, our study results will guide the design and conduct of a future efficacy trial.

Recruiting Women to a Mobile Health Smoking Cessation Trial: Low- and No-Cost Strategies.

BACKGROUND: Successful recruitment of participants to mobile health (mHealth) studies presents unique challenges over in-person studies. It is important to identify recruitment strategies that maximize the limited recruitment resources available to researchers. OBJECTIVE: The objective of this study was to describe a case study of a unique recruitment process used in a recent mHealth software app designed to increase smoking cessation among weight-concerned women smokers. The See Me Smoke-Free app was deployed to the Google Play Store (Alphabet, Inc., Google, LLC), where potential participants could download the app and enroll in the study. Users were invited in-app to participate in the study, with no in-person contact. The recruitment activities relied primarily on earned (free) and social media. METHODS: To determine the relationship between recruitment activities and participant enrollment, the researchers explored trends in earned and social media activity in relation to app installations, examined social media messaging in relation to reach or impressions, and described app users' self-reported referral source. The researchers collected and descriptively analyzed data regarding recruitment activities, social media audience, and app use during the 18-week recruitment period (March 30, 2015-July 31, 2015). Data were collected and aggregated from internal staff activity tracking documents and from Web-based data analytics software such as SumAll, Facebook Insights (Facebook, Inc.), and Google Analytics (Alphabet, Inc., Google, LLC). RESULTS: Media coverage was documented across 75 publications and radio or television broadcasts, 35 of which were local, 39 national, and 1 international. The research team made 30 Facebook posts and 49 tweets, yielding 1821 reaches and 6336 impressions, respectively. From March 30, 2015 to July 31, 2015, 289 unique users downloaded the app, and 151 participants enrolled in the study. CONCLUSIONS: Research identifying effective online recruitment methods for mHealth studies remains minimal, and findings are inconsistent. We demonstrated how earned media can be leveraged to recruit women to an mHealth smoking cessation trial at low cost. Using earned media and leveraging social media allowed us to enroll 3 times the number of participants that we anticipated enrolling. The cost of earned media resides in the staff time required to manage it, particularly the regular interaction with social media. We recommend communication and cooperation with university public affairs and social media offices, as well as affiliate programs in journalism and communications, so that earned media can be used as a recruitment strategy for mHealth behavior change interventions. However, press releases are not always picked up by the media and should not be considered as a stand-alone method of recruitment. Careful consideration of an intervention's broad appeal and how that translates into potential media interest is needed when including earned media as part of a comprehensive recruitment plan for mHealth research.

Development and evaluation of the See Me Smoke-Free multi-behavioral mHealth app for women smokers.

Women face particular challenges when quitting smoking, especially those with weight concerns. A multi-behavioral smoking cessation intervention addressing these concerns and incorporating guided imagery may assist women to engage in healthy lifestyle behaviors. An mHealth app can easily disseminate such an intervention. The goals of this pilot study were to develop and test the feasibility and potential of the See Me Smoke-Free™ mHealth app to address smoking, diet, and physical activity among women smokers. We used pragmatic, direct-to-consumer methods to develop and test program content, functionality, and the user interface and conduct a pre-/post-test, 90-day pilot study. We enrolled 151 participants. Attrition was 52%, leaving 73 participants. At 90 days, 47% of participants reported 7-day abstinence and significant increases in physical activity and fruit consumption. Recruitment methods worked well, but similar to other mHealth studies, we experienced high attrition. This study suggests that a guided imagery mHealth app has the potential to address multiple behaviors. Future research should consider different methods to improve retention and assess efficacy.

Development of a Multi-Behavioral mHealth App for Women Smokers.

This article describes the development of the See Me Smoke-Free™ (SMSF) mobile health application, which uses guided imagery to support women in smoking cessation, eating a healthy diet, and increasing physical activity. Focus group discussions, with member checks, were conducted to refine the intervention content and app user interface. Data related to the context of app deployment were collected via user testing sessions and internal quality control testing, which identified and addressed functionality issues, content problems, and bugs. Interactive app features include playback of guided imagery audio files, notification pop-ups, award-sharing on social media, a tracking calendar, content resources, and direct call to the local tobacco quitline. Focus groups helped design the user interface and identified several themes for incorporation into app content, including positivity, the rewards of smoking cessation, and the integrated benefits of maintaining a healthy lifestyle. User testing improved app functionality and usability on many Android phone models. Changes to the app content and function were made iteratively by the development team as a result of focus group and user testing. Despite extensive internal and user testing, unanticipated data collection and reporting issues emerged during deployment due not only to the variety of Android software and hardware but also to individual phone settings and use.

See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity.

BACKGROUND: This paper presents the protocol for an ongoing research study to develop and test the feasibility of a multi-behavioral mHealth app. Approximately 27 million women smoke in the US, and more than 180,000 women die of illnesses linked to smoking annually. Women report greater difficulties quitting smoking. Concerns about weight gain, negative body image, and low self-efficacy may be key factors affecting smoking cessation among women. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping women quit. Guided imagery has been successfully used to address body image concerns and self-efficacy in our 3 target behaviors-exercise, diet and smoking cessation. However, it has not been used simultaneously for smoking, diet, and exercise behavior in a single intervention. While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in person, which limits reach. mHealth apps delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. OBJECTIVE: The objective of our study is to evaluate the feasibility of an mHealth app for women designed to simultaneously address smoking, diet, and physical activity behaviors. The objectives are supported by three specific aims: (1) develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among women smokers, (2) program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features, and (3) evaluate the feasibility, acceptability, and preliminary efficacy of the app with women smokers. METHODS: We created the program content and designed the prototype application for use on the Android platform in collaboration with 9 participants in multiple focus groups and in-depth interviews. We programmed and tested the application's usability with 6 participants in preparation for an open, pre- and posttest trial. Currently, we are testing the feasibility and acceptability of the application, evaluating the relationship of program use to tobacco cessation, dietary behaviors, and physical activity, and assessing consumer satisfaction with approximately 70 women smokers with Android-based smart phones. RESULTS: The study was started January 1, 2014. The app was launched and feasibility testing began in April 1, 2015. Participants were enrolled from April 1-June 30, 2015. During that time, the app was downloaded over 350 times using no paid advertising. Participants were required to use the app "most days" for 30 days or they would be dropped from the study. We enrolled 151 participants. Of those, 78 were dropped or withdrew from the study, leaving 73 participants. We have completed the 30-day assessment, with a 92% response rate. The 90-day assessment is ongoing. During the final phase of the study, we will be conducting data analyses and disseminating study findings via presentations and publications. Feasibility will be demonstrated by successful participant retention and a high level of app use. We will examine individual metrics (eg, duration of use, number of screens viewed, change in usage patterns over time) and engagement with interactive activities (eg, activity tracking). CONCLUSIONS: We will aggregate these data into composite exposure scores that combine number of visits and overall duration to calculate correlations between outcome and measures of program exposure and engagement. Finally, we will compare app use between participants and non-participants using Google Analytics.

Guided Imagery for Arthritis and Other Rheumatic Diseases: A Systematic Review of Randomized Controlled Trials.

Many individuals suffering from arthritis and other rheumatic diseases (AORD) supplement pharmacologic treatments with psychosocial interventions. One promising approach, guided imagery, has been reported to have positive results in randomized controlled trials (RCTs) and is a highly scalable treatment for those with AORD. The main purpose of this study was to conduct a systematic review of RCTs that have examined the effects of guided imagery on pain, function, and other outcomes such as anxiety, depression, and quality of life in adults with AORD. Ten electronic bibliographic databases were searched for reports of RCTs published between 1960 and 2013. Selection criteria included adults with AORD who participated in RCTs that used guided imagery as a partial or sole intervention strategy. Risk of bias was assessed using the Cochrane Risk of Bias Assessment Instrument. Results were synthesized qualitatively. Seven studies representing 306 enrolled and 287 participants who completed the interventions met inclusion criteria. The average age of the participants was 62.9 years (standard deviation = 12.2). All interventions used guided imagery scripts that were delivered via audio technology. The interventions ranged from a one-time exposure to 16 weeks in duration. Risk of bias was low or unclear in all but one study. All studies reported statistically significant improvements in the observed outcomes. Guided imagery appears to be beneficial for adults with AORD. Future theory-based studies with cost-benefit analyses are warranted.