A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial.
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SUBMITTER: Martyn-Nemeth P
PROVIDER: S-EPMC6938021 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
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A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial.
Martyn-Nemeth Pamela P Duffecy Jennifer J Quinn Laurie L Park Chang C Mihailescu Dan D Penckofer Sue S
Trials 20191230 1
<h4>Background</h4>In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than o ...[more]
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Project description:ObjectiveTo evaluate the efficacy of a new video-based telehealth intervention to reduce hypoglycemia fear in parents of young children with type 1 diabetes.MethodsWe randomized 42 parents to either immediate treatment (reducing emotional distress for childhood hypoglycemia in parents, REDCHiP; n = 22) or a waitlist control (WAITLIST; n = 21) condition. REDCHiP parents completed a 10-session video-based telehealth intervention, while WAITLIST parents continued in usual care. After 14-weeks, WAITLIST parents completed the telehealth treatment. We examined for between group changes in parental hypoglycemia fear and parenting stress (n = 18 per condition), 3-month maintenance of treatment effects for parents randomized to REDCHiP (n = 15), and pre-post changes for the entire sample (n = 36).ResultsMostly mothers participated (97.6%). They reported a mean age of 35.2 ±?5.0?years at pre-treatment. Children were 4.4 ±?1.4?years old and 59.5% boys. Between group comparisons showed a significant reduction in hypoglycemia fear (P =?.04) and a trend toward reduction in parenting stress-frequency (P =?.092) for REDCHiP parents compared to WAITLIST parents. After the three-month maintenance period, REDCHiP parents reported significant reductions in hypoglycemia fear, parenting stress-frequency, and parenting stress-difficulty (P's <?.01) compared to pre-treatment. When all parents received the telehealth treatment, we also observed significant reductions in hypoglycemia fear, parenting stress-frequency, and parenting stress-difficulty (P's <?.001), and sensitivity analyses revealed a significant reduction in child glycated hemoglobin for children who entered the treatment above target (P <?.05).ConclusionOur new video-based telehealth intervention appears to reduce hypoglycemia fear and parenting stress and may help parents of very young children with T1D to better achieve optimal child glycemic control when children are above target.
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Project description:Background: Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. Materials and Methods: Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; n = 10) about intervention acceptability, facilitators, and challenges. Results: Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. Conclusions: The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.
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Project description:This study evaluated an Internet-delivered, cognitive behavioral skills training program versus a treatment-as-usual (TAU) control condition targeting depression symptoms in young adults aged 18 to 24 years. Potential participants were mailed a recruitment brochure; if interested, they accessed the study website to complete an online consent and baseline assessment. Intervention participants could access the website at their own pace and at any time. Reminder postcards were mailed periodically to encourage return use of the intervention. The pure self-help intervention was delivered without contact with a live therapist. The primary depression outcome measure was the Patient Health Questionnaire, administered at 0, 5, 10, 16, and 32 weeks after enrollment. A small but significant between-group effect was found from Week 0 to Week 32 for the entire sample (N = 160, d = .20, 95% confidence interval [CI] 0.00-0.50), with a moderate effect among women (n = 128, d .42, 95%C1 = 0.09-0.77). Greater depression reduction was associated with two measures of lower website usage, total minutes, and total number of page hits. Although intervention effects were modest, they were observed against a background of substantial TAU depression pharmacotherapy and psychosocial services. Highly disseminable, low-cost, and self-help interventions such as this have the potential to deliver a significant public health benefit.
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Project description:BACKGROUND:Heavy episodic (binge) drinking is common among young adults and can lead to injury and illness. Young adults who seek care in the Emergency Department (ED) may be disproportionately affected with binge drinking behavior, therefore provide an opportunity to reduce future risk through screening, brief intervention and referral to treatment (SBIRT). Mobile phone text messaging (SMS) is a common form of communication among young adults and has been shown to be effective at providing behavioral support to young adult drinkers after ED discharge. Efficacy of SMS programs to reduce binge drinking remains unknown. METHODS/DESIGN:We will conduct a three parallel arm, randomized trial. A convenience sample of adults aged 18 to 25 years attending three EDs in Pittsburgh, PA and willing to participate in the study will be screened for hazardous alcohol consumption. Participants identified as hazardous drinkers will then be allocated to either 12 weeks of weekly SMS drinking assessments with feedback (SA+F), SMS drinking assessments without feedback (SA), or a control group. Randomization will be via an independent and remote computerized randomization and will be stratified by study site. The SA+F group will be asked to provide pre-weekend drinking intention as well as post-weekend consumption via SMS and will receive feedback messages focused on health consequences of alcohol consumption, personalized normative feedback, protective drinking strategies and goal setting. Follow-up data on alcohol use and injury related to alcohol will be collected through a password-protected website three, six and nine months later. The primary outcome for the study is binge drinking days (?4 drinks for women; ?5 drinks for men) during the previous month, and the main secondary outcome is the proportion of participants who report any injury related to alcohol in the prior three months. DISCUSSION:This study will test the hypothesis that a mobile phone text-messaging program will result in immediate and durable reductions in binge drinking among at-risk young adults. By testing an intervention group to an assessment-only and control group, we will be able to separate the effect of assessment reactivity. By collecting pre-weekend drinking intentions and post-weekend consumption data in the SA+F group, we will be able to better understand mechanism of change. TRIAL REGISTRATION:Clinicaltrials.gov NCT01688245.
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Project description:BackgroundIncreasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults.ObjectiveIn this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial.MethodsIn the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463).ResultsResults will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021.ConclusionsThe findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial.Trial registrationInternational Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980.International registered report identifier (irrid)DERR1-10.2196/18929.
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Project description:BackgroundMore than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visual impairment, we developed E-nergEYEze, an eHealth intervention based on cognitive behavioral therapy and self-management tailored to the needs of visually impaired adults. The aim is to describe the study protocol of a randomized controlled trial testing E-nergEYEze.MethodsA randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of E-nergEYEze to reduce fatigue severity compared to care as usual from a healthcare and societal perspective. A total of 172 severely fatigued adults with visual impairment will be recruited and randomized to either the E-nergEYEze intervention plus care as usual or to care as usual only (ratio 1:1). Inclusion criteria are having a visual impairment, experiencing severe fatigue (Checklist Individual Strength - subscale Fatigue Severity: CIS-FS > 35), being 18 years or older, understanding the Dutch language, and having access to the internet. The intervention consists of one face-to-face session and a computer training followed by internet-based modules with information and assignments on coping with fatigue. During this 5-month intervention, participants will be digitally supported by a social worker. All measurements will be administered at baseline, after 6 and 12 months, and additionally, those related to cost-effectiveness at 3 and 9 months. The primary outcome is fatigue severity (CIS-FS).DiscussionSevere fatigue on top of visual impairment compromises quality of life and is associated with incremental societal costs that largely determine the economic burden of low vision or blindness. E-nergEYEze contributes to the evidence base of potentially feasible interventions to reduce the important health-related consequences of vision loss and could fulfill the gap in knowledge, skills and treatment options for low vision services.Trial registrationDutch Trial Register NTR7764 . Registered on 28 May 2019.
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Project description:BackgroundThis study describes the process evaluation of an intervention developed to reduce fear of falling (FoF) after hip fracture, within an inpatient geriatric rehabilitation setting. This 'FIT-HIP intervention' is a multicomponent cognitive behavioral intervention, conducted by physiotherapists and embedded in usual care in geriatric rehabilitation in the Netherlands. A previous study (cluster randomized controlled trial) showed no beneficial effects of this intervention when compared to usual care. The aim of this study was to gain insight into factors related to the intervention process that may have influenced the effectiveness of the intervention.MethodsThis process evaluation was conducted using an observational prospective study design. Based on quantitative and qualitative data derived from session logs, evaluation questionnaires and interviews, we addressed: 1] recruitment and reach; 2] performance according to protocol; 3] patients' adherence; and 4] opinions of patients and facilitators on the intervention. Participants in this study were: a) patients from 6 geriatric rehabilitation units, who were invited to participate in the intervention (39 adults aged ≥65 years with hip fracture and FoF) and; b) intervention facilitators (14 physiotherapists and 8 psychologists who provide coaching to the physiotherapists).ResultsThirty-six patients completed the intervention during inpatient geriatric rehabilitation. Apart from cognitive restructuring and telephonic booster (which was not provided to all patients), the intervention was performed to a fair degree in accordance with protocol. Patients' adherence to the intervention was very good, and patients rated the intervention positively (average 8.1 on a scale 0-10). Although most facilitators considered the intervention feasible, a limited level of FoF (possibly related to timing of intervention), and physiotherapists' limited experience with cognitive restructuring were identified as important barriers to performing the intervention according to protocol.ConclusionsThe FIT-HIP intervention was only partly feasible, which may explain the lack of effectiveness in reducing FoF. To improve the intervention's feasibility, we recommend selecting patients with maladaptive FoF (i.e. leading to activity restriction), being more flexible in the timing of the intervention, and providing more support to the physiotherapists in conducting cognitive restructuring.Trial registrationNetherlands Trial Register: NTR5695 (7 March 2016).
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Project description:BACKGROUND:Young people experiencing homelessness have alarmingly high rates of alcohol and other drug (AOD) use, which is associated with sexual risk behaviors such as unprotected sex, trading sex, and sex with multiple casual partners. Few risk reduction programs for this population have been developed and rigorously evaluated, particularly those that address both of these interrelated behaviors, use a collaborative and non-judgmental approach, and are feasible to deliver in settings where homeless young people seek services. This paper describes the protocol of a study evaluating a four-session Motivational Interviewing (MI)-based group risk reduction intervention for this population. The protocol has been shown to be efficacious in pilot work over 3 months with 200 homeless young adults [1]. The current study seeks to refine the intervention protocol and evaluate the program on a larger scale. METHODS/DESIGN:In a cluster-cross-over randomized controlled trial, 18-25 year olds will receive the AWARE risk reduction program (n?=?200) or standard care (n?=?200) at one of three drop-in centers serving homeless youth in the Los Angeles area. We will evaluate intervention effects on primary outcomes of AOD use and sexual risk behavior, as well as secondary outcomes of health-related quality of life and social stability, over a 12-month period. DISCUSSION:This project has the potential to fill a significant gap in prevention services by demonstrating that a brief intervention, feasible to deliver within settings where young people experiencing homelessness typically seeks services, can significantly reduce the interrelated problems of AOD use and sexual risk behavior. Trial registration ClinicalTrials.gov Identifier: NCT03735784. Registered November 18, 2018, https://clinicaltrials.gov/ct2/show/record/NCT03735784 (retrospectively registered).
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Project description:BackgroundDepression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT).MethodsA minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and within- and between-group effect sizes will be calculated.DiscussionInternet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors.Trial registrationClinicalTrials.gov NCT04728204. Registered on 15 January 2021. https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1.
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Project description:BackgroundAlthough largely preventable through diet management and topical fluoride use, early childhood caries (ECC) often progresses to severity that necessitates surgical repair. Yet repair often fails to mitigate caries progression. Needed is an effective behavioral intervention to address underlying behavioral causes.MethodsThis randomized controlled trial will evaluate the efficacy of a behaviorally focused, family-centered intervention, the MySmileBuddy Program (MSB Program), to reduce ECC progression in high-risk preschoolers in New York City. Recruitment will target 858 children ages 24-71 months with ECC and their parents from primary care medical and dental clinics. The study aims to assess the MSB Program's efficacy to: (1) decrease ECC progression measured 12-months post-randomization; and (2) enhance adoption of a low cariogenic diet and twice-daily fluoridated toothpaste use compared to control group. Potential causal pathways (mediators and moderators) will be explored. The MSB Program equips community health workers (CHWs) with an app that facilitates multilevel risk assessment and provides motivational interviewing-based counseling to inform parents about the caries process, develop personalized goals, and create family-level action plans to achieve targeted behaviors. Social support from CHWs (4 interactions during the 6-month intervention, supplemented by up to 4 in-person/remote contacts throughout the 12-month study period, based on need) is bolstered by automated text messages. Participants will be randomized to a Control Group (paper-based educational handout plus toothbrushes and fluoridated toothpaste for the child) or Intervention Group (MSB Program, two tooth-brushing observations with feedback and instruction, and toothbrushes and toothpaste for the entire family). All children will receive visual ICDAS dental examinations and parents will complete study measures at baseline and 12-months. An incentive up to $150 plus round-trip transit cards ($5.50 value) will be provided.DiscussionThis study hypothesizes that the MSB Program can reduce ECC progression in a high-risk population. Sufficient incentives and a focus on establishing rapport between participants and CHWs are anticipated to mitigate recruitment and retention challenges. If successful, this study will advance the long-term goal of reducing pediatric oral health disparities by demonstrating the efficacy of an acceptable and feasible intervention that shifts attention from dental repair to behavioral risk mitigation.Trial registrationTrial registration was completed on 4/13/2021 through the U.S. National Library of Medicine ClinicalTrials.gov website (Identifier: NCT04845594).
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