A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease.
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ABSTRACT:
SUBMITTER: Peerani F
PROVIDER: S-EPMC9520184 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
Publications
A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease.
Peerani Farhad F Watt Makayla M Ismond Kathleen P KP Whitlock Reid R Ambrosio Lindsy L Hotte Naomi N Mitchell Nicholas N Bailey Robert J RJ Kroeker Karen K Dieleman Levinus A LA Siffledeen Jesse J Lim Allen A Wong Karen K Halloran Brendan P BP Baumgart Daniel C DC Taylor Lorian L Raman Maitreyi M Madsen Karen L KL Tandon Puneeta P
Therapeutic advances in gastroenterology 20220927
<h4>Background</h4>Psychological stress negatively impacts inflammatory bowel disease (IBD) outcomes. Patients have prioritized access to online interventions; yet, the data on these have been limited by mixed in-person/online interventions, low adherence, and non-randomized controlled trial (RCT) design.<h4>Objectives</h4>We assessed the efficacy of and adherence to a 12-week online multicomponent stress reduction intervention in IBD.<h4>Design</h4>This is a RCT.<h4>Methods</h4>Adult participan ...[more]
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Project description:BackgroundOnline stress reduction interventions may be useful adjuncts to standard medical therapies for inflammatory bowel disease (IBD). As part of the evaluation of a 12-week randomized control trial (RCT) of an online multicomponent stress reduction program, our aim for the current study was to use qualitative methods to more deeply explore the patient experience with the online programming.MethodsUpon completion of the 12-week RCT, all intervention participants were invited to participate in semistructured interviews. A qualitative descriptive approach was used. Interviews were analyzed through a theoretical thematic analysis process, whereby transcripts were coded, and codes then grouped into larger categories and themes.ResultsA total of 56 interviews were analyzed with the emergence of 3 main themes: (1) IBD as a source of stress and uncertainty, (2) understanding the positive impacts of the stress reduction program, and (3) suggested strategies to enhance program desirability. IBD was described as causing uncertainty, significant disruptions to daily activities, and stress, which in turn worsened symptoms. The online program was associated with a perceived reduction in IBD symptom burden, an increased ability to manage daily and disease-associated stressors, and a more positive mindset. Variation in program content and fostering connections with others in the IBD community were identified as potential strategies to enhance future programming.ConclusionsThis qualitative companion study highlights the power of the patient voice to deepen our understanding of the impact of IBD, and the potential benefit of an online stress reduction program including suggestions for iterative refinement.
| S-EPMC9802265 | biostudies-literature
Project description:(1) Background: Stress, anxiety, and depression have been identified as factors that influence the development of inflammatory bowel disease (IBD). The main aim of this study was to test the effectiveness of group multicomponent cognitive-behavioral therapy at reducing stress, anxiety, and depression, and improving quality of life and the clinical course of the disease. (2) Methods: A total of 120 patients were evaluated using the General Perceived Stress Scale, Scale of Stress Perceived by the Disease, the anxiety and depression scale, and quality of life questionnaire for patients with IBD. Disease activity was measured using the Mayo Index for ulcerative colitis and CDAI for Crohn's disease, as well as the number of relapses self-reported by patients. Patients were randomized to receive group multicomponent cognitive-behavioral therapy or treatment as usual. (3) Results: The psychological intervention reduced stress (EAE: 45.7 ± 8.8 vs. 40.6 ± 8.4, p = 0.0001; PSS: 28.0 ± 7.3 vs. 25.1 ± 5.9, p = 0.001) and improved quality of life (164.2 ± 34.3 vs. 176.2 ± 28.0, p = 0.001). An improvement was found in the number of relapses self-reported by patients (0.2 relapses/patient vs. control 0.7 relapses/patient; p = 0.027). No differences were found in disease activity indexes. (4) Conclusions: Psychological therapy was associated with improved stress, quality of life and with a decrease in the number of relapses self-reported by patients. Clinical trial registration number: NCT02614014.
| S-EPMC8160847 | biostudies-literature
Project description:Fibromyalgia (FM) is a prevalent, chronic, disabling, pain syndrome that implies high healthcare costs. Economic evaluations of potentially effective treatments for FM are needed. The aim of this study was to analyze the cost-utility of Mindfulness-Based Stress Reduction (MBSR) as an add-on to treatment-as-usual (TAU) for patients with FM compared to an adjuvant multicomponent intervention ("FibroQoL") and to TAU. We performed an economic evaluation alongside a 12 month, randomized, controlled trial; data from 204 (68 per study arm) of the 225 patients (90.1%) were included in the cost-utility analyses, which were conducted both under the government and the public healthcare system perspectives. The main outcome measures were the EuroQol (EQ-5D-5L) for assessing Quality-Adjusted Life Years (QALYs) and improvements in health-related quality of life, and the Client Service Receipt Inventory (CSRI) for estimating direct and indirect costs. Incremental cost-effectiveness ratios (ICERs) were also calculated. Two sensitivity analyses (intention-to-treat, ITT, and per protocol, PPA) were conducted. The results indicated that MBSR achieved a significant reduction in costs compared to the other study arms (p < 0.05 in the completers sample), especially in terms of indirect costs and primary healthcare services. It also produced a significant incremental effect compared to TAU in the ITT sample (ΔQALYs = 0.053, p < 0.05, where QALYs represents quality-adjusted life years). Overall, our findings support the efficiency of MBSR over FibroQoL and TAU specifically within a Spanish public healthcare context.
| S-EPMC6678679 | biostudies-literature
Project description:BackgroundPhysical exercise is an effective strategy for preserving functional capacity and improving the symptoms of frailty in older adults. In addition to functional gains, exercise is considered to be a cornerstone for enhancing cognitive function in frail older adults with cognitive impairment and dementia. We assessed the effects of the Vivifrail exercise intervention for functional capacity, cognition, and well-being status in community-dwelling older adults.MethodsIn a multicentre randomized controlled trial conducted in three tertiary hospitals in Spain, a total of 188 older patients with mild cognitive impairment or mild dementia (aged >75 years) were randomly assigned to an exercise intervention (n = 88) or a usual-care, control (n = 100) group. The intervention was based on the Vivifrail tailored multicomponent exercise programme, which included resistance, balance, flexibility (3 days/week), and gait-retraining exercises (5 days/week) and was performed for three consecutive months (http://vivifrail.com). The usual-care group received habitual outpatient care. The main endpoint was change in functional capacity from baseline to 1 and 3 months, assessed with the Short Physical Performance Battery (SPPB). Secondary endpoints were changes in cognitive function and handgrip strength after 1 and 3 months, and well-being status, falls, hospital admission rate, visits to the emergency department, and mortality after 3 months.ResultsThe Vivifrail exercise programme provided significant benefits in functional capacity over usual-care. The mean adherence to the exercise sessions was 79% in the first month and 68% in the following 2 months. The intervention group showed a mean increase (over the control group) of 0.86 points on the SPPB scale (95% confidence interval [CI] 0.32, 1.41 points; P < 0.01) after 1 month of intervention and 1.40 points (95% CI 0.82, 1.98 points; P < 0.001) after 3 months. Participants in the usual-care group showed no significant benefit in functional capacity (mean change of -0.17 points [95% CI -0.54, 0.19 points] after 1 month and -0.33 points [95% CI -0.70, 0.04 points] after 3 months), whereas the exercise intervention reversed this trend (0.69 points [95% CI 0.29, 1.09 points] after 1 month and 1.07 points [95% CI 0.63, 1.51 points] after 3 months). Exercise group also obtained significant benefits in cognitive function, muscle function, and depression after 3 months over control group (P < 0.05). No between-group differences were obtained in other secondary endpoints (P > 0.05).ConclusionsThe Vivifrail exercise training programme is an effective and safe therapy for improving functional capacity in community-dwelling frail/prefrail older patients with mild cognitive impairment or mild dementia and also seems to have beneficial effect on cognition, muscle function, and mood status.
| S-EPMC8977963 | biostudies-literature
Project description:BackgroundVideoconferencing-based treatments have shown great potential in increasing engagement and compliance by decreasing the barriers of time and distance. In general, employees tend to experience a lot of stress, but find it difficult to visit a clinic during office hours.ObjectiveThe purpose of this study was to investigate the effectiveness of a mobile videoconference-based intervention for stress reduction and resilience enhancement in employees.MethodsIn total, 81 participants were randomly allocated to one of the three conditions: mobile videoconferencing, in-person, and self-care; of these, 72 completed the study. All participants underwent assessment via self-reported questionnaires before, immediately after, and 1 month after the intervention. Intervention lasted for 4 weeks and consisted of elements of cognitive behavioral therapy, positive psychology, and meditation. Changes in clinical variables regarding stress and resilience across time were compared between treatment conditions.ResultsThere were significant condition × time effects on variables measuring perceived stress, resilience, emotional labor, and sleep, demonstrating significantly differential effects across time according to treatment condition. Moreover, there were significant effects of condition on perceived stress and occupational stress. There were no significant differences in any variable between the mobile videoconferencing and in-person conditions at 1 month after the intervention.ConclusionsResults indicate that both mobile videoconferencing and in-person interventions were comparably effective in decreasing stress and enhancing resilience. Further studies with a larger sample size and a longer follow-up period are warranted to investigate the long-term effect of mobile videoconferencing interventions.Trial registrationClinicalTrials.gov identifier NCT03256682; https://clinicaltrials.gov/ct2/show/NCT03256682 (Archived by WebCite at http://www.webcitation.org/71W77bwnR).
| S-EPMC6234345 | biostudies-literature
Project description:The rise in mental health concerns of university students is causing a serious hinderance to their wellbeing, impeding their functioning. The socio-economic and political friction in low- and middle-income countries adds to their vulnerability and calls for a cost-effective indigenous intervention. Consequently, this study aimed to inform a large definitive trial by assessing the feasibility and acceptability of a randomized controlled trial (RCT) design evaluating a culturally adapted online Mindfulness Training Course (MTC) used to improve stress and wellbeing among Pakistani university students. A two-arm pilot randomized controlled trial was conducted. University students (n = 156) were randomly assigned to either the MTC group (n = 80) or Wait-list (WL) control group (n = 76) and completed baseline and post-intervention self-report measures for mindfulness, stress and psychological wellbeing. Additionally, semi-structured interviews were conducted with consenting MTC group participants (n = 18) to explore their views about MTC, employing reflexive thematic analysis. Of 80 participants randomized to the MTC group, 32 completed the course, whereas, from the 156 randomized participants, 102 completed assessment surveys. Feasibility and acceptability indicators showed high recruitment, compliance, and adherence to MTC, with practical steps for randomization and online data collection. Further results showed higher levels of mindfulness and psychological wellbeing and lowered stress levels in the MTC group compared to the control group. The attrition and dropout rates were high; however, the feedback from participants who completed the MTC was highly positive and encouraging. In conclusion, if the trial proceeds with increased outreach in a large-scale RCT, the recruitment might be revised to reduce attrition rates. Further recommendations are discussed.
| S-EPMC10139103 | biostudies-literature
Project description:BACKGROUND:Many cancers are preventable through lifestyle modification; however, few adults engage in behaviors that are in line with cancer prevention guidelines. This may be partly due to the mixed messages on effective cancer prevention strategies in popular media. The goal of the McMaster Optimal Aging Portal (the Portal) is to increase access to trustworthy health information. The purpose of this study was to explore if and how knowledge translation strategies to disseminate cancer prevention evidence using the Portal influence participants' knowledge, intentions and health behaviors related to cancer risk. METHODS:Adults ≥40 years old, with no cancer history were randomized to a 12-week intervention (weekly emails and social media posts) or control group. Quantitative data on knowledge, intentions and behaviors (physical activity, diet, alcohol consumption and use of tobacco products) were collected at baseline, end of study and 3 months later. Participant engagement was assessed using Google Analytics, and participant satisfaction through open-ended survey questions and semi-structured interviews. RESULTS:Participants (n = 557, mean age 64.9) were predominantly retired (72%) females (81%). Knowledge of cancer prevention guidelines was higher in the intervention group at end of study only (+ 0.3, p = 0.01). Intentions to follow cancer prevention guidelines increased in both groups, with no between-group differences. Intervention participants reported greater light-intensity physical activity at end of study (+ 0.7 vs. 0.1, p = 0.03), and reduced alcohol intake at follow u (- 0.2 vs. + 0.3, p < 0.05), but no other between-group differences were found. Overall satisfaction with the Portal and intervention materials was high. CONCLUSIONS:Dissemination of evidence-based cancer prevention information through the Portal results in small increases in knowledge of risk-reduction strategies and with little to no impact on self-reported health behaviours, except in particular groups. Further tailoring of knowledge translation strategies may be needed to see more meaningful change in knowledge and health behaviours. TRIAL REGISTRATION:ClinicalTrials.gov NCT03186703, June 14, 2017.
| S-EPMC6873728 | biostudies-literature
Project description:BackgroundDespite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse.ObjectiveThe primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention.MethodsWe are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation.ResultsThis project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025.ConclusionsThis pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities.Trial registrationClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542.International registered report identifier (irrid)PRR1-10.2196/46307.
| S-EPMC10285620 | biostudies-literature
Project description:BackgroundPatients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support.ObjectiveThis study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support.MethodsA total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress.ResultsThe intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions.ConclusionsOur results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication.Trial registrationClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725.International registered report identifier (irrid)RR2-10.2196/38536.
| S-EPMC11751654 | biostudies-literature
Project description:IntroductionThis pilot randomized controlled trial sought to evaluate whether an online intervention for problem gambling could lead to improved gambling outcomes compared to a no intervention control. Participants were recruited through a crowdsourcing platform.MethodsParticipants were recruited to complete an online survey about their gambling through the Mechanical Turk platform. Those who scored 5 or more on the Problem Gambling Severity Index and were thinking about quitting or reducing their gambling were invited to complete 6-week and 6-month follow-ups. Each potential participant who agreed was sent a unique password. Participants who used their password to log onto the study portal were randomized to either access an online intervention for gambling or to a no intervention control.ResultsA total of 321 participants were recruited, of which 87% and 88% were followed-up at 6 weeks and 6 months, respectively. Outcome analyses revealed that, while there were reductions in gambling from baseline to follow-ups, there was no significant observable impact of the online gambling intervention, as compared to a no intervention control condition.ConclusionsWhile the current trial observed no impact of the intervention, replication is merited with a larger sample size, and with participants who are not recruited through a crowdsourcing platform.Trial registration: ClinicalTrials.govNCT03124589.
| S-EPMC6542746 | biostudies-literature