Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230).
Ontology highlight
ABSTRACT:
SUBMITTER: Griggs S
PROVIDER: S-EPMC10249334 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
Publications
Cognitive Behavioral Sleep Self-Management Intervention for Young Adults With Type 1 Diabetes (NCT04975230).
Griggs Stephanie S Hernandez Estefania E Bolton Pamela J PJ Strohl Kingman P KP Grey Margaret M Kashyap Sangeeta R SR Li Chiang-Shan R CR Hickman Ronald L RL
Clinical nursing research 20230214 3
The purpose of this study was to explore perceptions of the first dose of a cognitive behavioral sleep self-management intervention (CB-sleep) among young adults aged 18 to 25 years with type 1 diabetes (T1D). We used a qualitative descriptive approach to conduct in-depth semi-structured focused interviews with a purposive sample of 16 young adults with T1D, transitioning from adolescence to early adulthood. Interviews were audio-recorded, transcribed verbatim, and analyzed using qualitative con ...[more]
Similar Datasets
Project description:BackgroundSelf-management of type 1 diabetes (T1D) is complex and can be particularly challenging for young adults. This is reflected in the high blood glucose values and rates of clinic non-attendance in this group. There is a gap for a theory-based intervention informed by key stakeholder opinions to support and improve self-management in young adults with T1D.PurposeThe aim of the work was to systematically co-develop an evidence-based and stakeholder-led intervention to support self-management and clinic engagement in young adults living with T1D in Ireland. Co-development was led by the Young Adult Panel.MethodsThe Behaviour Change Wheel was used to guide the development. Five evidence sources were used to inform the process. An iterative co-design process was used with the Young Adult Panel. Initial intervention components were refined and feasibility tested using qualitative methods.ResultsEnvironmental restructuring, education and training were selected as appropriate intervention functions. The co-design process, along with qualitative refinement and feasibility work, led to the final intervention content which consisted of 17 behaviour change techniques. The final D1 Now intervention consists of three components: a support worker, an agenda setting tool and an interactive messaging service.ConclusionsThe D1 Now intervention is now at pilot evaluation stage. Its transparent and systematic development will facilitate evaluation and future replications.
| S-EPMC8513171 | biostudies-literature
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.
| S-EPMC2829099 | biostudies-literature
Project description:AimsElevated depressive symptoms are common among adults with type 2 diabetes (T2D). In a secondary analysis from an RCT of a diabetes self-management support intervention that did not target depressive symptoms, we sought to determine if depressive symptoms were reduced by the intervention (i.e., depressive symptoms an outcome) or, alternatively, if intervention effects on hemoglobin A1c were lesser among persons with clinically elevated depressive symptoms (i.e., depressive symptoms an effect modifier).MethodsWe evaluated a text messaging intervention, REACH, in a diverse (half non-white, half underinsured) sample of N = 506 adults with T2D. Participants completed the Patient Health Questionnaire-8 (PHQ) and A1c tests at baseline and 6 months. We conducted a factor analysis to identify somatic- and cognitive-affective symptoms on the PHQ. We tested our hypotheses with regression models, using interaction terms and subgroup analyses.ResultsREACH improved depressive symptoms among participants with lower baseline A1c (<8.5%; β = -0.133, p = .007; cognitive β = -0.107, p = .038; somatic β = -0.131, p = .014) but not among participants with higher baseline A1c (≥8.5%; β = 0.040, p = .468). Baseline depressive symptoms did not modify the effect on A1c.ConclusionsWe found support for the hypothesis that depressive symptoms - both somatic- and cognitive-affective - may be an outcome, rather than an effect modifier, of effective diabetes self-management support interventions.
| S-EPMC8511161 | biostudies-literature
Project description:BackgroundMultiple randomized controlled trials (RCTs) show that behavioral lifestyle interventions are effective in improving diabetes management and that comprehensive risk factor management improves cardiovascular disease (CVD) outcomes. The role of technology has been gaining strong support as evidence builds of its potential to improve diabetes management; however, evaluation of its impact in minority populations is limited. This study intends to provide early evidence of a theory-driven intervention, Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS), using real-time videoconferencing for education and skills training. We examine the potential for TABLETS to improve health risk behaviors and reduce CVD risk outcomes among a low-income African American (AA) population with poorly controlled type 2 diabetes.MethodsThe study is a two-arm, pilot controlled trial that randomizes 30 participants to the TABLETS intervention and 30 participants to a usual care group. Blinded outcome assessments will be completed at baseline, 2.5 months (immediate post-intervention), and 6.5 months (follow-up). The TABLETS intervention consists of culturally tailored telephone-delivered diabetes education and skills training delivered via videoconferencing on tablet devices, with two booster sessions delivered via tablet-based videoconferencing at 3 months and 5 months to stimulate ongoing use of the tablet device with access to intervention materials via videoconferencing slides and a manual of supplementary materials. The primary outcomes are physical activity, diet, medication adherence, and self-monitoring behavior, whereas the secondary outcomes are HbA1c, low-density lipoprotein cholesterol (LDL-C), BP, CVD risk, and quality of life.DiscussionThis study provides a unique opportunity to assess the feasibility and efficacy of a theory-driven, tablet-aided behavioral intervention that utilizes real-time videoconferencing technology for education and skills training on self-management behaviors and quality of life among a high-risk, low-income AA population with an uncontrolled dyad or triad of CVD risk factors (diabetes with or without hypertension or hyperlipidemia). The intervention leverages the use of novel technology for education and skill-building to foster improved diabetes self-management. The findings of this study will inform the process of disseminating the intervention to a broader and larger sample of people and can potentially be refined to align with clinical workflows that target a subsample of patients with poor diabetes self-management.Trial registrationThe trial was registered in April 2014 with the United States National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier NCT02128854), available online at: http://clinicaltrials.gov/ct2/show/NCT02128854 .
| S-EPMC4804482 | biostudies-literature
Project description:BACKGROUND: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 other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). METHODS/DESIGN:A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. DISCUSSION:Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. TRIAL REGISTRATION:ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.
| S-EPMC6938021 | biostudies-literature
Project description:BackgroundAlthough supported self-management is a well-recognised part of chronic disease management, it has not been routinely used as part of healthcare for adults with a learning disability. We developed an intervention for adults with a mild or moderate learning disability and type 2 diabetes, building on the principles of supported self-management with reasonable adjustments made for the target population.MethodsIn five steps, we:Clarified the principles of supported self-management as reported in the published literatureIdentified the barriers to effective self-management of type 2 diabetes in adults with a learning disabilityReviewed existing materials that aim to support self-management of diabetes for people with a learning disabilitySynthesised the outputs from the first three phases and identified elements of supported self-management that were (a) most relevant to the needs of our target population and (b) most likely to be acceptable and useful to themImplemented and field tested the intervention.ResultsThe final intervention had four standardised components: (1) establishing the participant's daily routines and lifestyle, (2) identifying supporters and their roles, (3) using this information to inform setting realistic goals and providing materials to the patient and supporter to help them be achieved and (4) monitoring progress against goals.Of 41 people randomised in a feasibility RCT, thirty five (85%) completed the intervention sessions, with over three quarters of all participants (78%) attending at least three sessions.Twenty-three out of 40 (58%) participants were deemed to be very engaged with the sessions and 12/40 (30%) with the materials; 30 (73%) participants had another person present with them during at least one of their sessions; 15/41 (37%) were reported to have a very engaged main supporter, and 18/41 (44%) had a different person who was not their main supporter but who was engaged in the intervention implementation.ConclusionsThe intervention was feasible to deliver and, as judged by participation and engagement, acceptable to participants and those who supported them.Trial registrationCurrent Controlled Trials ISRCTN41897033 (registered 21/01/2013).
| S-EPMC5975532 | biostudies-literature
Project description:Diabetes self-management education (DSME) is a fundamental element of type 2 diabetes care. Although 75% of adults with diabetes worldwide live in low-income and middle-income countries (LMICs), limited DSME research has been conducted in LMICs. The objective of this study was to evaluate a home-based DSME intervention in rural Guatemala.We conducted a prospective study of a DSME intervention using a quasi-experimental, single-group pretest-posttest design. We enrolled 90 participants in the intervention, which consisted of 6 home visits (May 2014-July 2016) conducted by a diabetes educator using a curriculum culturally and linguistically tailored to rural Mayan populations. Primary outcomes were changes in mean hemoglobin A1c (HbA1c) and mean systolic and diastolic blood pressure at baseline and at 12 months. Secondary outcomes were diabetes knowledge and self-care activities at baseline and intervention completion.HbA1c decreased significantly from baseline to 12 months (absolute mean change, -1.5%; 95% confidence interval [CI], -1.9% to -1.0%; P < .001). Systolic blood pressure also improved significantly at 12 months (-6.2 mm Hg; 95% CI, -10.1 to -2.2 mm Hg; P = .002); changes in diastolic blood pressure were not significant (-1.6 mm Hg; 95% CI, -3.9 to -0.7 mm Hg; P = .17). We also found significant improvements in diabetes knowledge and self-care activities from baseline to intervention completion.DSME interventions can be successfully delivered in a setting with an underresourced health system, high poverty rate, and unique cultural characteristics like Mayan Guatemala. Our findings point to the need for more DSME research in resource-limited settings globally.
| S-EPMC5553353 | biostudies-other
Project description:BACKGROUND:Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE:The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS:This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS:The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS:This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION:ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).
| S-EPMC5010649 | biostudies-literature
Project description:AimYoung-onset type 2 diabetes (YOD) is associated with poorer clinical outcomes. To support the development of more effective diabetes self-management education (DSME) programmes, this study aimed to understand the preferences of young adults with YOD in relation to the modality, content and qualities of DSME.MethodsMaximal variation sampling was employed to recruit participants of varied age, ethnicity and marital status. In-depth interviews using a semistructured questionnaire were conducted. Subsequently, thematic analysis with coding and conceptualisation of data was applied to identify the main themes regarding DSME.Results21 young adult participants aged 22-39 years were interviewed from three polyclinics in Singapore. The most used modalities for DSME included education from healthcare providers, information and support from family and friends and information from internet sources. Participants were most interested in information regarding diet, age-specific diabetes-related conditions and medication effects. Additionally, participants valued DSME that was credible, accessible, individualised and empathetic. Conversely, absence of the above qualities and stigma hindered participants from receiving DSME.ConclusionOur study explored the preferences of young adults with YOD with regard to DSME, identifying the most used modalities, preferred content and qualities that were valued by young adults. Our findings will help inform the development of DSME programmes that can better meet the needs and preferences of young adults with YOD.
| S-EPMC11227779 | biostudies-literature
Project description:BackgroundInsomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and adverse effects from pharmaceutical insomnia treatment. To address current limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, we are conducting a randomized pilot study to test a brief (4- week), tablet-based, personalized, multicomponent behavioral sleep intervention (MBSI) for insomnia, compared to a sleep education control, in a sample of older adults with mild cognitive impairment.MethodsParticipants will be randomized in a 1:1 ratio to intervention or control group. Both groups will complete three virtual study data collection visits: baseline, 4-week post-intervention, and 12-week post-intervention follow-up. Key components of the 4-week intervention include sleep hygiene education, stimulating meaningful activity during the day and promoting relaxation therapy at night. We will determine preliminary immediate (4-week) and sustained efficacy (12-week) of MBSI compared to sleep education on sleep related outcomes and health related quality of life. Additionally, we will explore mechanisms by which the intervention affects sleep and health related quality of life using standardized questionnaires and inflammatory biomarkers.Results(N/A).DiscussionThe findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.
| S-EPMC10068807 | biostudies-literature