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A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial.

ABSTRACT: BACKGROUND:The integration of Behavioral Activation Treatment for Depression (BAT-D) into smoking cessation interventions is a promising approach to address depression as a barrier to quitting. However, this approach has only been tested as a face-to-face intervention, which has low reach. OBJECTIVE:The aims of the study were to develop a BAT-D mobile health app with high potential reach and determine its feasibility, acceptability, and preliminary effects on theory-based behavioral processes of behavioral activation, reduced depressive symptoms, and smoking cessation. METHODS:Following a user-centered design process consisting of competitive analysis, focus groups, and prototype testing, we conducted a single-arm pilot trial of Actify!, a BAT-D app for depressed smokers. Participants used SmokefreeTXT along with Actify! to provide cessation content that had not yet been built into the app for this initial phase of pilot testing. Participants in the trial were current, daily smokers with mild to moderate depressive symptoms. We examined use outcomes for all enrolled participants and process and cessation outcomes at 6 weeks postenrollment for study completers (16/17, 94% retention). RESULTS:Regarding acceptability, average number of log-ins per participant was 16.6 (SD 13.7), and 63% (10/16) reported being satisfied overall with the app. Posttreatment interviews identified some usability challenges (eg, high perceived burden of planning and scheduling values-based activities). There was a significant decrease in depressive symptoms from baseline to follow-up (mean change in Patient Health Questionnaire-9 scores was -4.5, 95% CI -7.7 to -1.3; P=.01). Additionally, carbon monoxide (CO)-confirmed, 7-day point prevalence abstinence (PPA) at 6-week follow-up was 31% (5/16), and the 30-day PPA was 19% (3/16). CONCLUSIONS:Results demonstrate promising engagement with Actify! and potential for impact on theory-based change processes and cessation outcomes. Preliminary quit rates compare favorably to previous trials of smoking cessation apps for the general population (ie, short-term, self-reported 30-day quit rates in the 8% to 18% range) and a previous trial of face-to-face BAT-D for depressed smokers (ie, CO-confirmed, 7-day PPA rate of 17% at end of treatment).

SUBMITTER: Heffner JL

PROVIDER: S-EPMC6913543 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial.

Heffner Jaimee L JL Watson Noreen L NL Serfozo Edit E Mull Kristin E KE MacPherson Laura L Gasser Melissa M Bricker Jonathan B JB

JMIR formative research 20191127 4

<h4>Background</h4>The integration of Behavioral Activation Treatment for Depression (BAT-D) into smoking cessation interventions is a promising approach to address depression as a barrier to quitting. However, this approach has only been tested as a face-to-face intervention, which has low reach.<h4>Objective</h4>The aims of the study were to develop a BAT-D mobile health app with high potential reach and determine its feasibility, acceptability, and preliminary effects on theory-based behavior ...[more]

PMID: 31774405

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Project description:BackgroundEmpowering young people with type 1 diabetes (T1D) to manage their blood glucose levels during exercise is a complex challenge faced by health care professionals due to the unpredictable nature of exercise and its effect on blood glucose levels. Mobile health (mHealth) apps would be useful as a decision-support aid to effectively contextualize a blood glucose result and take appropriate action to optimize glucose levels during and after exercise. A novel mHealth app acT1ve was recently developed, based on expert consensus exercise guidelines, to provide real-time support for young people with T1D during exercise.ObjectiveOur aim was to pilot acT1ve in a free-living setting to assess its acceptability and functionality, and gather feedback on the user experience before testing it in a larger clinical trial.MethodsA prospective single-arm mixed method design was used. Ten participants with T1D (mean age 17.7 years, SD 4.2 years; mean HbA1c, 54 mmol/mol, SD 5.5 mmol/mol [7.1%, SD 0.5%]) had acT1ve installed on their phones, and were asked to use the app to guide their exercise management for 6 weeks. At the end of 6 weeks, participants completed both a semistructured interview and the user Mobile Application Rating Scale (uMARS). All semistructured interviews were transcribed. Thematic analysis was conducted whereby interview transcripts were independently analyzed by 2 researchers to uncover important and relevant themes. The uMARS was scored for 4 quality subscales (engagement, functionality, esthetics, and information), and a total quality score was obtained from the weighted average of the 4 subscales. Scores for the 4 objective subscales were determined by the mean score of each of its individual questions. The perceived impact and subjective quality of acT1ve for each participant were calculated by averaging the scores of their related questions, but were not considered in the total quality score. All scores have a maximal possible value of 5, and they are presented as medians, IQRs, and ranges.ResultsThe main themes arising from the interview analysis were "increased knowledge," "increased confidence to exercise," and "suitability" for people who were less engaged in exercise. The uMARS scores for acT1ve were high (out of 5) for its total quality (median 4.3, IQR 4.2-4.6), engagement (median 3.9, IQR 3.6-4.2), functionality (median 4.8, IQR 4.5-4.8), information (median 4.6, IQR 4.5-4.8), esthetics (median 4.3, IQR 4.0-4.7), subjective quality (median 4.0, IQR 3.8-4.2), and perceived impact (median 4.3, IQR 3.6-4.5).ConclusionsThe acT1ve app is functional and acceptable, with a high user satisfaction. The efficacy and safety of this app will be tested in a randomized controlled trial in the next phase of this study.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619001414101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378373.

Project description:BackgroundLong-term maintenance of preventive activities is fundamental for achieving improved outcomes in cardiac rehabilitation (CR). Despite this, it has been shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-healthy lifestyle. Mobile phone apps have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app to promote long-term adherence to preventive activities after attendance in CR, a study to assess if it is feasible to use an app is warranted.ObjectiveThe goal of the research is to assess if it is feasible to use a mobile phone app for promoting and monitoring patients' adherence to a heart-healthy lifestyle after CR.MethodsThe study included an experimental, pre-post single-arm trial lasting for 12 weeks. All patients received access to an app aimed to guide individuals to change or maintain a heart-healthy lifestyle. During the study period, patients received weekly, individualized monitoring through the app, based on their own goals. Feasibility outcomes assessed were recruitment rate, adherence to the app, resource requirements, and efficacy regarding capability to detect a change in quality of life, health status, and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria for success were preset to be able to evaluate whether the app was feasible to use in a potential future RCT.ResultsIn total, 71% (17/24) of the patients who completed CR were eligible for a potential RCT as well as for this study. All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology was high, and the patients found the technology-based follow-up intervention both useful and motivational. Ceiling effect was present in more than 20% of the patients in several domains of the questionnaires evaluating quality of life (36-Item Short Form Health Survey and COOP/WONCA functional health assessments) and health status (EQ-5D). Overall self-rated health status (EuroQol Visual Analog Scale) and perceived goal achievement were found to be outcomes able to detect a change.ConclusionsIndividual follow-up through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the app both useful and motivating. Several points of guidance from the patients in the study have been adopted and incorporated into the final design of the RCT now in the field.

Project description:BackgroundYouth are globally recognized as being vulnerable to HIV. Younger age has been correlated with worse health outcomes. Mobile health (mHealth) interventions have the potential to interact with youth where they are, using a device they already access.ObjectiveUsing predefined benchmarks, we sought to evaluate the feasibility and acceptability of WYZ, an mHealth app, for improved engagement in care and antiretroviral therapy (ART) adherence among youth and young adults living with HIV. WYZ was designed and developed with input from youth and young adults living with HIV using a human-centered design approach and was based on the information, motivation, and behavioral skills framework to address common barriers to care and ART adherence among youth and young adults living with HIV.MethodsWe recruited youth and young adults living with HIV (18-29 years old) from the San Francisco Bay Area to take part in a 6-month pilot trial. Their participation included completing baseline and exit surveys, and participating in seven phone check-ins about their use of WYZ.ResultsYouth and young adults living with HIV (N=79) reported high levels of feasibility and acceptability with WYZ use. We met predefined benchmarks for recruitment (79/84, 94%), mean logins per week (5.3), tracking ART adherence (5442/9393, 57.9%), posting chat topics per week (4.8), and app crashes reported per week (0.24). The ease of app download, install, and setup, and comfort with security, privacy, and anonymity were highly rated (all over 91%). Additionally, participants reported high satisfaction for a research project that was remotely conducted. Participants used the app for shorter timeframes compared to the predefined benchmark.ConclusionsWe noted high feasibility and acceptability with WYZ. Further research to examine the efficacy of WYZ will enable youth and young adults living with HIV and their providers to make informed decisions when using, recommending, and prescribing the app for improved engagement in HIV care and ART adherence.Trial registrationClinicalTrials.gov NCT03587857; https://clinicaltrials.gov/ct2/show/NCT03587857.

Project description:BACKGROUND:Cystic fibrosis (CF) continues to be the most common life-limiting chronic pulmonary disease in adolescents and young adults. Treatment of CF demands a high treatment time investment to slow the progression of lung function decline, the most important contributor to morbidity and mortality. Adherence is challenging in CF due to the high treatment burden and the lack of immediate health consequences in case of nonadherence. Lung function decline is particularly pronounced in the transition phase between 12 and 24 years of age. The improvement of self-management and self-responsibility and independence from parents and desire for normalcy are conflicting aspects for many adolescents with CF, which influence adherence to the time-consuming pulmonary therapy. Mobile health (mHealth) care apps could help to support self-management and independence and thereby reconcile seemingly conflicting goals to improve adherence, quality of life, and ultimately CF life expectancy. OBJECTIVE:This study aimed to (1) assess user behavior and satisfaction among adolescents and young adults with CF over an observation period of three months using an mHealth app; (2) identify areas of improvement for this mHealth app; and (3) compare overall and disease-specific satisfaction, lung function, and anthropometry before and after using the mHealth app. METHODS:A total of 27 adolescents and young adults with CF (age range 12-24 years, mean age 16 years, SD 3 years; 14 females, 11 males) used a free mHealth app for three months of whom 25 provided questionnaire data for analysis at the end of the study. Data collection was carried out using questionnaires on usage characteristics and life satisfaction, and standardized assessment of lung function and anthropometry. RESULTS:The use of the reminder function for medication declined from 70% (15/21) of the participants at week 4 to 65% (13/20) at week 8 of the observation period. At the end of the study, only 17% (4/23) of the participants wanted to continue using the app. Nevertheless, 56% (14/25) of participants saw the mobile app as a support for everyday life. Potential improvements targeting hedonistic qualities were identified to improve mHealth app adherence. Comparisons of satisfaction with different life aspects hinted at improvements or stabilization for the subitem respiration and the subitem lack of handicap by CF, suggesting that app use might stabilize certain CF-specific aspects of the weighted satisfaction with life. Lung function and anthropometry were not affected consistently. CONCLUSIONS:Most of the patients did not want to continue using the app after the study period. Only a few CF-specific aspects of weighted life satisfaction were possibly stabilized by the mHealth app; clinical parameters were not affected. Adaptation of the functions to adolescent-specific needs could improve the long-term use and thus positively affect the disease course.

Project description:BackgroundChronic low back pain is challenging to manage due to multidisciplinary considerations. It has substantial socioeconomic impacts and cannot be simply treated with pharmacotherapy, nonsurgical intervention, or spine surgery. Medical consensus recommends optimizing conservative self-management therapies (eg, home exercise, wellness strategies, yoga, etc) as first-line treatment options for chronic low back pain. However, access to these modalities is often limited and secondary to cost, convenience, and ease of use. Mobile health apps have emerged as a cost-effective and accessible option for chronic low back pain self-management. Established in-person pain programs can provide the structure for an optimal mobile app adaptation. PainNavigator (PainNavigator, Inc) is an example of a mobile app that is based on an Ascension-Illinois group-based pain program-Pain Rehabilitation Outpatient-Camp.ObjectiveThis was a prospective pilot clinical trial that evaluated the PainNavigator platform's utility in low back pain management to inform future trial development.MethodsA total of 75 participants who used PainNavigator were studied. Pain, Enjoyment, and General Activity (PEG-3) scale scores and scores from a brief anxiety and depression scale based on the Patient Health Questionnaire-4 (PHQ-4) were obtained at baseline and following program completion. The PEG-3 total score was used, in addition to individual items-Average Pain, Pain Effect on Enjoyment, and Pain Effect on Activity. The PHQ-4 total score was also used, in addition to other individual items, including Felt Depressed, Loss of Interest, Felt Anxious, and Difficult to Control Worry. Paired sample t tests (2-tailed) compared mean differences in scores from before and after participants received the intervention.ResultsThe analysis found that PEG-3 (n=27) and PHQ-4 (n=27) total scores were significantly lower upon the completion of PainNavigator (P<.001 and P=.001, respectively). The findings showed a 36% reduction in PEG-3 total scores, a 40% reduction in pain intensity, and a 40% reduction in PHQ-4 total scores. Scores for individual PEG-3 scale and PHQ-4 items also significantly decreased. All PEG-3 measures had large effect sizes. The PHQ-4 total score and Difficult to Control Worry item had large effect sizes, while the other three measures had medium effect sizes.ConclusionsThese findings show that PainNavigator has clinical significance in managing chronic low back pain and can be easily utilized to improve patient care. All PEG-3 scale and PHQ-4 measures significantly improved following the use of the platform, supporting the multidimensional, biopsychosocial approach to low back pain management. Differences in effect sizes may inform quality improvement investigations, such as optimizing features that impact measures with only medium effect sizes. This feasibility study demonstrates an effective protocol, and it will inform future, more extensive randomized controlled trials.

Project description:BackgroundAlthough the American Heart Association and other professional societies have recommended shared decision-making as a way for patients with atrial fibrillation (AF) or atrial flutter to make informed decisions about using anticoagulation (AC), the best method for facilitating shared decision-making remains uncertain.ObjectiveThe aim of this study is to assess the AFib 2gether mobile app for usability, perceived usefulness, and the extent and nature of shared decision-making that occurred for clinical encounters between patients with AF and their cardiology providers in which the app was used.MethodsWe identified patients visiting a cardiology provider between October 2019 and May 2020. We measured usability from patients and providers using the Mobile App Rating Scale. From the 8 items of the Mobile App Rating Scale, we reported the average score (out of 5) for domains of functionality, esthetics, and overall quality. We administered a 3-item questionnaire to patients relating to their perceived usefulness of the app and a separate 3-item questionnaire to providers to measure their perceived usefulness of the app. We performed a chart review to track the occurrence of AC within 6 months of the index visit. We also audio recorded a subset of the encounters to identify evidence of shared decision-making.ResultsWe facilitated shared decision-making visits for 37 patients visiting 13 providers. In terms of usability, patients' average ratings of functionality, esthetics, and overall quality were 4.51 (SD 0.61), 4.26 (SD 0.51), and 4.24 (SD 0.89), respectively. In terms of usefulness, 41% (15/37) of patients agreed that the app improved their knowledge regarding AC, and 62% (23/37) agreed that the app helped clarify to their provider their preferences regarding AC. Among providers, 79% (27/34) agreed that the app helped clarify their patients' preferences, 82% (28/34) agreed that the app saved them time, and 59% (20/34) agreed that the app helped their patients make decisions about AC. In addition, 32% (12/37) of patients started AC after their shared decision-making visits. We audio recorded 25 encounters. Of these, 84% (21/25) included the mention of AC for AF, 44% (11/25) included the discussion of multiple options for AC, 72% (18/25) included a provider recommendation for AC, and 48% (12/25) included the evidence of patient involvement in the discussion.ConclusionsPatients and providers rated the app with high usability and perceived usefulness. Moreover, one-third of the patients began AC, and approximately 50% (12/25) of the encounters showed evidence of patient involvement in decision-making. In the future, we plan to study the effect of the app on a larger sample and with a controlled study design.Trial registrationClinicalTrials.gov NCT04118270; https://clinicaltrials.gov/ct2/show/NCT04118270.International registered report identifier (irrid)RR2-21986.

Dataset Information

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial.

Publications

A Behavioral Activation Mobile Health App for Smokers With Depression: Development and Pilot Evaluation in a Single-Arm Trial.

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