Major depressive disorder (MDD) is prevalent, yet sub-optimally treated among persons with multiple sclerosis (MS). We propose that exercise training may be a promising approach for treating ...depression in persons with MS who have MDD. Our primary hypothesis predicts a reduction in depression severity immediately after an exercise training intervention compared with minimal change in an attention control condition, and the reduction will be maintained during a follow-up period.
This study involves a parallel-group, assessor-blinded RCT that examines the effect of a 4-month home-based exercise training intervention on depression severity in a sample of persons with MS who have MDD based on the MINI International Neuropsychiatric Interview. The primary outcomes of depression severity are the Patient Health Questionnaire-9 and Hamilton Depression Rating Scale. Participants (N = 146) will be recruited from within 200 miles of the University of Illinois at Chicago and randomized (1:1) into either a home-based exercise training condition or control condition with concealed allocation. The exercise training and social-contact, attention control (i.e., stretching) conditions will be delivered remotely over a 4-month period and supported through eight, 1:1 Zoom-based behavioral coaching sessions guided by social-cognitive theory and conducted by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcome data at 0, 4 and 8 months using treatment-blinded assessors, and data analyses will involve intent-to-treat principles.
If successful, the proposed study will provide the first Class I evidence supporting a home-based exercise training program for treating MDD in persons with MS. This is critical as exercise training would likely have positive secondary effects on symptoms, cognition, and quality of life, and provide a powerful, behavioral approach for managing the many negative outcomes of MDD in MS. The program in the proposed research is accessible and scalable for broad treatment of depression in MS, and provides the potential for integration in the clinical management of MS.
The trial was registered on September 10, 2021 at clinicaltrials.gov with the identifier NCT05051618. The registration occurred before we initiated recruitment on June 2, 2023.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Medical students experience high rates of depression, and often face barriers to receiving traditional mental health services. Internet-based cognitive behavioral therapy (iCBT) programs offer a more ...accessible method of receiving care. Here, we conducted an open trial of an iCBT program for medical students and characterize program usage, program users, and self-reported psychosocial symptoms and coping skills.
All incoming first year medical students at a large state-run university were invited to use an iCBT program which focused on mood management and mood symptom prevention. Participants received access to the 16-week program and completed measures of perceived stress, quality of life, and the development of cognitive and behavioral coping skills at baseline and end of program.
Of the 194 students in the class, 53 (27.32%) signed up to use the program. While the program attracted a representative portion of underrepresented minority students, program engagement among males was particularly low. Repeated use of the program was low. Self-reported symptoms of depression and anxiety were low at baseline, and continued to be low at end of program. Slight increases were observed from baseline to end of program in the self-reported use of cognitive coping skills.
Digital mental health tools appear to be of interest to first year medical students, but need to be better designed to support continued program use and to attract specific subgroups of students who may face additional barriers to seeking mental health services.
•In a first-year medical school class of 194 students, 53 (27.32%) signed up to use an internet-based cognitive behavioral therapy (iCBT) program focused on mood management and mood symptom prevention.•The program attracted a reasonable portion of underrepresented minority students, program engagement among males was particularly low.•Repeated use of the program was low overall.•First year medical students appear to be interested in digital mental health tools, but these programs need to be better designed to support continued program use
Short sleep duration, defined as < 7 h sleep on weeknights, affects 40% of the US adult population, contributing to the increased risk for cardiometabolic diseases, decreased safety, and poorer ...mental health. Despite the prevalence of short sleep duration, few studies have tested interventions to extend sleep duration. The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of cardiometabolic health among adults with elevated blood pressure or hypertension.
This is a single-blind, randomized controlled trial to determine the impact of a behavioral sleep extension intervention on sleep duration and cardiometabolic health among individuals with short sleep duration (< 7 h per night) and elevated blood pressure or hypertension (SBP 120-150 mmHg or DBP 80-90 mmHg). After completing the screening, participants will be randomly assigned to either a sleep coaching (intervention) or health education (control) group. The participants will have weekly contact for either coaching or education for 8 weeks (intervention period) followed by monthly coaching or education for the next 2 months (maintenance period). Participants will complete assessment visits, actigraphy, and 24-h ambulatory blood pressure recording at baseline/screening, 8 weeks, and 6 and 12 months. The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks.
The results of this study will determine the effects of behavioral sleep extension on sleep and cardiometabolic health among adults with short sleep duration and elevated BP/hypertension. The results will inform the feasibility and efficacy of behavioral sleep extension and provide information needed for future multi-site effectiveness studies.
ClinicalTrials.gov NCT04766424. Registered on 21 February 2021.
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).
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.
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.
ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.
Abstract
Background
Despite extensive benefits and high intentions, few mothers breastfeed exclusively for the recommended duration. Maternal mental health is an important underlying factor ...associated with barriers and reduced rates of breastfeeding intent, initiation, and continuation. Given evidence of a bidirectional association between maternal mental health and breastfeeding, it is important to consider both factors when examining the efficacy of interventions to improve these outcomes. The purpose of this manuscript is to review the literature on the efficacy of behavioral interventions focused on both maternal mental health and breastfeeding outcomes, examining the intersection of the two.
Methods
This systematic review was completed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. Studies were selected if they were available in English, used primary experimental design, and used a behavioral intervention type to examine maternal mental health and breastfeeding outcomes. Articles were identified from PubMed, CINAHL, Embase, and PsycINFO from database inception to 3 March 2022. Study quality was assessed using the Cochrane Risk of Bias tool. Results were synthesized by intervention success for 1. Mental health and breastfeeding, 2. Breastfeeding only, 3. Mental health only, and 4. No intervention effect. PROSPERO CRD42021224228.
Results
Thirty interventions reported in 33 articles were identified, representing 15 countries. Twelve studies reported statistically significant positive effect of the intervention on both maternal mental health and breastfeeding; most showing a decrease in self-report depressive and/or anxiety symptoms in parallel to an increase in breastfeeding duration and/or exclusivity. Common characteristics of successful interventions were a) occurring across pregnancy and postpartum, b) delivered by hospital staff or multidisciplinary teams, c) offered individually, and d) designed to focus on breastfeeding and maternal mental health or on breastfeeding only. Our results are not representative of all countries, persons, experiences, circumstances, or physiological characteristics.
Conclusions
Interventions that extend the perinatal period and offer individualized support from both professionals and peers who collaborate through a continuum of settings (e.g., health system, home, and community) are most successful in improving both mental health and breastfeeding outcomes. The benefits of improving these outcomes warrant continued development and implementation of such interventions.
Systematic review registration
PROSPERO CRD42021224228.
Objective
Medical school presents a time of psychological distress for many students, who are less likely than the general population to seek mental health treatment due to multiple treatment ...barriers. Internet-based cognitive behavioral therapy (iCBT) programs may be an acceptable option for medical students. This study aims to assess acceptability and usability of ThinkFeelDo, an iCBT program, and to examine the impact of the program on perceived stress, quality of life, and the development of cognitive and behavioral coping skills.
Method
Fourteen medical students (M age = 25.4 years, 50% female) participated in the 6-week ThinkFeelDo program and completed baseline and end of treatment assessments.
Results
ThinkFeelDo was used (login M = 11.9, SD = 9.8) and was rated as somewhat useful. Participants requested further refinement of lessons to better fit the typical narrative of a medical student and endorsed interest in the program being offered at the beginning of medical school. At end of program, participants increased the frequency with which they used cognitive and behavioral coping skills,
t
(10) = −3.400,
p
= .007.
Conclusions
Results of this study indicate that medical students are willing to utilize online mental health programs and may receive benefit. However, the sample was small, self-selected, and without a comparison group. Feedback collected through this study provides insight on how to effectively integrate iCBT programs into the medical school experience.
The goal of this study was to examine the contribution of sleep extension intervention components (wearable sleep tracker and coaching) on sleep extension outcomes.
This study collected open ended ...qualitative responses of treatment preference, acceptability, and feasibility as a key outcome.
Adults aged 25 to 65 years with sleep duration <7 h and BMI ≥ 25 were randomized into one of four groups: Self-Management (control), Fitbit, Telephone Coaching, or Fitbit + Coaching. Self-report questionnaires and actigraphy were completed at baseline, post-intervention (6 weeks), and 12-weeks. Analyses used mixed models.
Among the 38 adults randomized, the Fitbit + Coaching group had larger but non-significant improvements in sleep duration compared with the self-management group. The coaching group demonstrated significant improvements in sleep-related impairment. All groups demonstrated feasibility and acceptability but the Fitbit + Coaching group reported themes of accountability.
Results suggest that sleep extension interventions are feasible and acceptable but components affect the pattern of sleep and other outcomes.
Sleep extension is feasible and acceptable; the combination of coaching and the wearable device may lead to larger changes in sleep due to enhanced accountability.
•We tested the components of sleep extension interventions, including wearable technology and brief telephone coaching.•All interventions were rated as easy to use and well-liked by participants.•Qualitative feedback demonstrated sentiment of accountability reported by the group that received a fitbit+coaching.•Results demonstrated that all interventions extended sleep, but the largest improvement was seen in the fitbit+coaching group.
Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable ...target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life have also been linked to sleep variability and insufficient sleep duration. A significant gap of knowledge exists regarding interventions to improve sleep and the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration, and glycemic control (A1C); other glycemic parameters (glycemic variability, time-in-range TIR); diabetes distress; self-management behaviors; quality of life; and other patient-reported outcomes in adults with T1D and habitual increased sleep variability or short sleep duration.
A randomized controlled parallel-arm study will be employed in 120 adults (aged 18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (> 1 h/week) or insufficient sleep duration (< 6.5 h per night). Eligible subjects will be randomized to the Sleep-Opt intervention group or healthy living attention control group for 12 weeks. A 1-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and TIR using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life, and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that we recently developed that leverages the rapidly increasing public interest in sleep tracking. Our behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. Baseline measures will be repeated at midpoint, program completion, and post-program (weeks 6, 12, and 24, respectively) to determine differences between the two groups and sustainability of the intervention.
A better understanding of strategies to improve sleep in persons with T1D has the potential to be an important component of diabetes.
Clinical Trial Registration: NCT04506151 .
Women with a history of gestational diabetes (GDM) are at 7-fold increase in the risk of developing diabetes. Insufficient sleep has also been shown to increase diabetes risk. This study aimed to ...explore the feasibility of a sleep extension in women with a history of GDM and short sleep, and effects on glucose metabolism.
Women age 18-45 years with a history of GDM and actigraphy confirmed short sleep duration (<7 h/night) on weekdays were randomized at a ratio of 1 control (heathy living information) to 2 cases (6 weeks of "Sleep-Extend" intervention: use of a Fitbit, weekly digital content, and weekly coaching to increase sleep duration). An oral glucose tolerance test (OGTT), 7-day actigraphy recording, and questionnaires were obtained at baseline and 6 weeks. Mean differences between baseline and end-of-intervention parameters were compared using independent samples t-tests.
Mean (SD) sleep duration increased within the Sleep-Extend group (n=9, +26.9 (42.5) min) but decreased within the controls (n=5, - 9.1 (20.4) min), a mean difference (MD) of 35.9 min (95% confidence interval (CI) - 8.6, 80.5). Fasting glucose increased, but less in Sleep-Extend vs. control groups (1.6 (9.4) vs 10.4 (8.2) mg/dL, MD - 8.8 mg/dL (95% CI - 19.8, 2.1), while 2-h glucose levels after an OGTT did not differ. Compared to controls, Sleep-Extend had decreased fatigue score (MD - 10.6, 95%CI - 20.7, - 0.6), and increased self-report physical activity (MD 5036 MET- minutes/week, 95%CI 343, 9729. Fitbit compliance and satisfaction in Sleep-Extend group was high.
Sleep extension is feasible in women with a history of GDM, with benefits in fatigue and physical activity, and possibly glucose metabolism. These data support a larger study exploring benefits of sleep extension on glucose metabolism in these high-risk women.
ClinicalTrials.gov , NCT03638102 (8/20/2018).
In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the ...potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies.
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