scholarly journals Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0244717
Author(s):  
Jennifer L. Huberty ◽  
Jeni Green ◽  
Megan E. Puzia ◽  
Linda Larkey ◽  
Breanne Laird ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Sleep Arousal

The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also explored in the intervention group only. Adults with sleep disturbance were recruited (N = 640). Eligible and consenting participants (N = 263) were randomly assigned to the intervention (n = 124) or a wait-list control (n = 139) group. Intervention participants were asked to meditate using the Calm app ≥10 minutes/day for eight weeks. Fatigue, daytime sleepiness, and pre-sleep arousal were assessed at baseline, mid- (4-weeks) and post-intervention (8-weeks) in both groups, whereas sleep quality was evaluated only in the intervention group. Findings from intent-to-treat analyses suggest the use of the Calm app for eight weeks significantly decreased daytime fatigue (p = .018) as well as daytime sleepiness (p = .003) and cognitive (p = .005) and somatic (p < .001) pre-sleep arousal as compared to the wait-list control group. Within the intervention group, use of the Calm app was associated with improvements in sleep quality (p < .001). This randomized controlled trial demonstrates that the Calm app can be used to treat fatigue, daytime sleepiness, and pre-sleep arousal in adults with sleep disturbance. Given that the Calm app is affordable and widely accessible, these data have implications for community level dissemination of a mobile app to improve sleep-related symptoms associated with sleep disturbance. Trial registration: ClinicalTrials.gov NCT04045275.

Meaning and Purpose (MaP) therapy II: Feasibility and acceptability from a pilot study in advanced cancer

2019 ◽  
Vol 17 (1) ◽  
pp. 21-28 ◽  
Author(s):  
David W. Kissane ◽  
Carrie Lethborg ◽  
Joanne Brooker ◽  
Courtney Hempton ◽  
Sue Burney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Posttraumatic Growth ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Wait List ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Meaning And Purpose

AbstractObjectiveMeaning and Purpose (MaP) therapy aims to enhance meaning-based coping through a life review that focuses on the value and worth of the person, key relationships, sources of fulfillment, roles, and future priorities in living life out fully. We sought to test the feasibility and acceptability of a six-session model of MaP therapy against a wait-list control cohort in a pilot study seeking effect sizes on measures of adaptation.MethodWe randomized patients with advanced cancer to MaP therapy or wait-list control, with measures administered at baseline and after 6–8 weeks. Wait-list patients could then crossover to receive therapy, with further measures collected postintervention. Adherence to the manualized model was sustained through weekly supervision and fidelity coding of recorded sessions. We used generalized estimating equations to control for baseline and any correlation of data.ResultFrom 134 eligible participants, 57 (43%) consented, and 40 of 45 (89%) offered therapy completed 6 sessions. Key barriers to consenting patients were poor health (15 refusers and 4 withdrawals) and death intervened in 6 participants. MaP therapy generated adequate effect sizes in posttraumatic growth (new possibilities, appreciation of life, and personal strength) and life attitudes (choices and goal seeking) to permit calculation of power for a formal randomized, controlled trial.Significance of resultsDelivery of this model of existentially oriented therapy is feasible and acceptable to patients. A properly powered randomized controlled trial is justified to examine the efficacy of this intervention.

scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Integrative Health ◽  
Randomized Controlled

BACKGROUND Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13666

scholarly journals A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bettina Wollesen ◽  
Madeleine Fricke ◽  
Carl-Philipp Jansen ◽  
Katharina Gordt ◽  
Michael Schwenk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Spatial Orientation ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Abstract Background In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents. Methods A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated. Discussion This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations. Trial registration The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).

scholarly journals Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Gabriel G Edwards ◽  
Cathy J Reback ◽  
William E Cunningham ◽  
Charles L Hilliard ◽  
Charles McWells ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Substance Use ◽  
Service Utilization ◽  
Controlled Trial ◽  
Intervention Group ◽  
Transgender Women ◽  
Mobile App ◽  
Peer Mentor ◽  
Randomized Controlled ◽  
Sex With Men

BACKGROUND Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one’s social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women. OBJECTIVE The purpose of this study is to test a new intervention—Mobile-Enhanced Prevention Support (MEPS)—that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services. METHODS A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism. RESULTS Enrollment began in November 2019 and study completion is expected in 2023. CONCLUSIONS This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant–peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm. CLINICALTRIAL ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18106

Evaluation of My Stress Control, a web-based stress management program for persons experiencing work-related stress: A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Caroline Eklund ◽  
Anne Söderlund ◽  
Magnus L Elfström
Keyword(s):  
Randomized Controlled Trial ◽  
Stress Management ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Wait List ◽  
Post Intervention ◽  
Web Based ◽  
Stress Control ◽  
Randomized Controlled

BACKGROUND Stress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown effective at addressing several health-related problems. To handle stress on an individual level is about behavior change. To support behavior change in stress management My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models but central in the development was Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user's specific need for stress management and behavior change. OBJECTIVE The aim of this study was to conduct a randomized controlled trial to evaluate the extent to which MSC affected perceived stress in persons experiencing work-related stress. METHODS This study was conducted as a randomized controlled trial with two arms. Study participants were recruited by visiting worksites and workplace meetings. Participants were assigned to intervention or wait list group. Web-based questionnaires were used pre- and post-intervention to collect data. Perceived stress measured with the Perceived Stress Scale (PSS-14) was the primary outcome measurement. Analyses were conducted for both between- and within-group changes. RESULTS A total of 92 participants were included in this study, 48 in intervention group and 44 in waitlist group. Twelve participants in the intervention group and 19 participants in the waitlist group completed the post intervention assessment. There were no significant effects on perceived stress between the intervention and wait list groups or within the groups. A small effect size (dCohen=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait list groups. Additionally, a small effect size was found between pre- and post-intervention assessment within the intervention group (dCohen=0.38) as well as within the wait list group (dCohen=0.25). CONCLUSIONS It is still uncertain what effect My Stress Control (MSC) may have on perceived stress. Because adherence was low in the intervention group, elements or features that facilitate adherence must be further developed before firmer conclusions of the effect of MSC can be studied. CLINICALTRIAL This RCT was registered at clinicaltrials.gov, protocol record 2015/0646.

scholarly journals Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Young Ho Yun ◽  
EunKyo Kang ◽  
Young Min Cho ◽  
Sang Min Park ◽  
Yong-Jin Kim ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Disease Control ◽  
Behavior Management ◽  
Management Strategy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile App ◽  
Control Group ◽  
Cardiovascular Risks ◽  
Randomized Controlled

BACKGROUND In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. OBJECTIVE This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health–based electronic program (Smart Healthing). METHODS A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA<sub>1c</sub>) &lt;7.0%, systolic blood pressure (SBP) &lt;140 mmHg, or low-density lipoprotein cholesterol &lt;130 mg/dL. RESULTS The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (<italic>P</italic>&lt;.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; <italic>P</italic>&lt;.05). There was a significant reduction in HbA<sub>1c</sub> in the intervention group compared with the control group (difference=0.54%; <italic>P</italic>≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA<sub>1c</sub> (vs 0% among controls; <italic>P</italic>≤.05). CONCLUSIONS A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. CLINICALTRIAL ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044

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