A randomized controlled trial of the online OurRelationship program with varying levels of coach support.
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SUBMITTER: Le Y
PROVIDER: S-EPMC10477807 | biostudies-literature | 2023 Dec
REPOSITORIES: biostudies-literature
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A randomized controlled trial of the online OurRelationship program with varying levels of coach support.
Le Yunying Y Roddy McKenzie K MK Rothman Karen K Salivar Emily Georgia EG Guttman Shayna S Doss Brian D BD
Internet interventions 20230828
Online programs that reduce relationship distress fill a critical need; however, their scalability is limited by their reliance on coach calls. To determine the effectiveness of the online OurRelationship program with varying levels of coach support, we conducted a comparative effectiveness trial with 740 low-income couples in the United States. Couples were randomly assigned to full-coach (<i>n</i><sub><i>couples</i></sub> = 226; program as originally designed), automated-coach (<i>n</i><sub><i ...[more]
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Project description:BackgroundVeterans are disproportionately affected by chronic pain, with high rates of pain diagnoses (47%-56%) and a 40% higher rate of prevalence of severe pain than nonveterans. This is often accompanied by negative functional outcomes and higher mortality. Combined with research suggesting medical treatments for chronic pain are often insufficient, there is an urgent need for nonmedical pain self-management programs. An interactive online platform to deliver an efficacious treatment for chronic pain such as acceptance and commitment therapy (ACT) could be a valuable option to assist veterans with pain care at home.ObjectiveThis study aims to evaluate the virtual coach-guided Veteran ACT for Chronic Pain (VACT-CP) online program compared to a waitlist and treatment as usual (WL+TAU) control group through a small pilot feasibility randomized controlled trial. The primary aim was to evaluate the feasibility and acceptability of VACT-CP and study procedures, such as ease of recruitment, treatment receptivity, attrition and retention, sustained participation, system usability, and assessment of trial procedures. Secondary aims explored differences in the VACT-CP and WL+TAU groups on pre- and posttest (week 7) outcome measures for pain, mental health, functioning, and ACT processes.MethodsVeterans with chronic pain were recruited and randomized to either the VACT-CP (n=20) or the WL+TAU (n=22) group in a parallel group trial design. Self-report surveys were administered to participants at baseline (week 0), at the intervention midpoint (week 3), immediately after the intervention (week 7), and at the 1-month follow-up (week 11). We used Wilcoxon signed rank tests with the intention-to-treat sample to describe changes in secondary outcomes from pre- to postintervention within each group.ResultsStudy procedures showed good feasibility related to recruitment, enrollment, randomization, and study completion rates. Participants reported that VACT-CP was easy to use (System Usability Scale: mean 79.6, SD 12.8; median 82.5, IQR 70-87.5); they completed an average of 5 of the 7 total VACT-CP modules with high postintervention satisfaction rates. Qualitative feedback suggested a positive response to program usability, content tailoring, veteran centeredness, and perceived impact on pain management. Although the pilot feasibility trial was not powered to detect differences in clinical outcomes and significant findings should be interpreted with caution, the VACT-CP group experienced significant increases in chronic pain acceptance (P<.001) and decreases in depressive symptoms (P=.03).ConclusionsVACT-CP showed encouraging evidence of feasibility, usability, and acceptance, while also providing promising initial results in improving a key process in ACT for chronic pain-chronic pain acceptance-after online program use. A full-scale efficacy trial is needed to assess changes in clinical outcomes.Trial registrationClinicalTrials.gov NCT03655132; http://clinicaltrials.gov/ct2/show/NCT03655132.International registered report identifier (irrid)RR2-10.2196/45887.
| S-EPMC11584538 | biostudies-literature
Project description:BackgroundDisadvantaged populations face many barriers to cancer care, including limited support in navigating through the complexities of the healthcare system. Family members play an integral role in caring for patients and provide valuable care coordination; however, the effect of family navigators on adherence to cancer screening has not previously been evaluated. Training and evaluating trusted family members and other support persons may improve cancer outcomes for vulnerable patients.MethodsGuided by principles of community based participatory research (CBPR), "Evaluating Coaches of Older Adults for Cancer Care and Healthy Behaviors (COACH)" is a community-based randomized controlled trial to assess the effectiveness of a trained participant-designated coach (support person or care giver) in navigating cancer-screening for older African American adults, 50-74 years old. Participants are randomly assigned as dyads (participant+coach pair) to receiving either printed educational materials only (PEM--control group) or educational materials plus coach training (COACH--intervention group). We defined a coach as family member, friend, or other lay support person designated by the older adult. The coach training is designed as a one-time, 35- to 40-minute training consisting of: 1) a didactic session that covers the role of the coach, basic facts about colorectal, breast and cervical cancers (including risk factors, signs and symptoms and screening modalities), engaging the healthcare provider in cancer screening, insurance coverage for screening, and related healthcare issues, 2) three video skits addressing misconceptions about and planning for cancer screening, and 3) an interactive role-play session with the trainer to reinforce and practice strategies for encouraging the participant to get screened. The primary study outcome is the difference in the proportion of participants completing at least one of the recommended screenings (for breast, cervix or colorectal cancer) between the control and intervention groups.DiscussionBuilding on trusted patient contacts to encourage cancer screening, COACH is a highly sustainable intervention in a high-risk population. It has the potential to minimize the effect of mistrust of the medical establishment on screening behaviors by mobilizing participants' existing support networks. If effective, the intervention could have a high impact on health care disparities research across multiple diseases.Trial registrationClinicalTrials.gov ( NCT01613430 ). Registered June 5, 2012.
| S-EPMC4647280 | biostudies-literature
Project description:ObjectiveCommunication difficulties negatively impact relationship quality and are associated with social isolation and loneliness in later life. There is a need for accessible communication interventions offered outside specialty mental health settings.DesignPilot randomized controlled trial.SettingAssessments in the laboratory and intervention completed in-home.ParticipantsTwenty adults age 60 and older from the community and a geriatric psychiatry clinic.InterventionA web-based communication coach that provides automated feedback on eye contact, facial expressivity, speaking volume, and negative content (Aging and Engaging Program, AEP), delivered with minimal assistance in the home (eight brief sessions over 4-6 weeks) or control (education and videos on communication).MeasurementsSystem Usability Scale and Social Skills Performance Assessment, an observer-rated assessment of social communication elicited through standardized role-plays.ResultsNinety percent of participants completed all AEP sessions and the System Usability Scale score of 68 was above the cut-off for acceptable usability. Participants randomized to AEP demonstrated statistically and clinically significant improvement in eye contact and facial expressivity.ConclusionThe AEP is acceptable and feasible for older adults with communication difficulties to complete at home and may improve eye contact and facial expressivity, warranting a larger RCT to confirm efficacy and explore potential applications to other populations, including individuals with autism and social anxiety.
| S-EPMC8140061 | biostudies-literature
Project description:Objectives: To evaluate the process of implementing a web-based support program (SUPR) for hearing aid users in the Dutch dispensing setting in order to allow interpretation of the randomized controlled trial's results (positive effects on hearing-aid related outcomes; no effects on psychosocial outcomes). Design: Measures: context of implementation, recruitment, SUPR's: reach, implementation fidelity, dose delivered, dose received, satisfaction, and benefit. Data collection: quantitative and qualitative. Study Sample: One hundred thirty-eight clients (mean age 68.1 years; 60% male) and 44 dispensers completed questionnaires. Five clients and 6 dispensers participated in interviews and focus groups. Results: Clients and dispensers were generally satisfied with SUPR's usefulness. SUPR-videos were watched by 7-37% of the clients. Around half of the dispensers encouraged clients to watch them or informed them about SUPR. Some clients found the SUPR-materials suboptimal, and changes in personnel and limited dispenser-training were barriers acting on a contextual level. Conclusions: This study identified several factors that contributed to the success of SUPR. Others factors, acting on various levels (e.g., intervention material, dispensers, and implementation context), were suboptimal and may explain the absent psychosocial effects. The identified factors are important to consider in further development of SUPR, and in other web-based support programs.
| S-EPMC8569232 | biostudies-literature
Project description:BackgroundiSupport is an online program developed by the World Health Organization to provide education, skills training, and social support to informal carers of persons with dementia. This pilot study examines the feasibility of the protocol for a main effectiveness trial of iSupport-Portugal and explores how the intervention and control arms compare over time on well-being outcomes.MethodsA mixed-methods experimental parallel between-group design with two arms is followed. Participants were recruited nationwide, by referral or advertising, through the National Alzheimer's Association. Inclusion criteria are being Portuguese adults, providing e-consent, providing unpaid care to someone with dementia for at least 6 months, experiencing relevant scores on burden (≥ 21 on ZBI) or depression or anxiety (≥ 8 on HADS), and using webpages autonomously. Participants were consecutively randomized to receive iSupport-Portugal or an education-only e-book and were not blinded to group assignment. Data were collected online with self-administered instruments, at baseline, 3 and 6 months after. Outcomes comprise caregiver burden, depression, anxiety, QoL, positive aspects of caregiving, and self-efficacy. Generalized estimating equations were used to estimate group, time, and group-by-time effects. Intervention engagement data were extracted from iSupport's platform. Semi-structured interviews were conducted.ResultsForty-two participants were allocated to the intervention (N = 21) and control (N = 21) arms. Participation (78.1%) and retention rates (73.8%) were fair. More carers in the control arm completed the study (N = 20, 95.2%) than in the intervention arm (N = 11; 52.4%) (χ2 = 9.98, p = .002). Non-completers were younger, spent less time caring, and scored higher on anxiety. Among carers in the intervention arm, the average attendance rate was of 53.7%. At post-test 38.9% of participants still used iSupport; the remainder participants interrupted use within 2 weeks (Mdn). For per-protocol analyses, significant group-by-time interaction effects favouring the intervention were found for anxiety (Wald χ2 = 6.17, p = .046) and for environmental QoL (Wald χ2 = 7.06, p = .029). Those effects were not observed in intention-to-treat analyses adjusted for age. Interviewees from the intervention arm (N = 12) reported positive results of iSupport on knowledge and on experiencing positive feelings. No adverse effects were reported.ConclusionsThis study provides information for a forthcoming full-scale effectiveness trial, as on the acceptability and potential results of iSupport-Portugal. iSupport is suggested as a relevant resource for Portuguese carers.Trial registrationClinicalTrials.gov, NCT04104568 . 26/09/2019.
| S-EPMC8887647 | biostudies-literature
Project description:BackgroundHome-visiting programs are a common and effective public health approach to promoting parent and child well-being, including in low- and middle-income countries. The World Health Organization and UNICEF have identified responsive caregiving as one key component of the nurturing care children need to survive and thrive. Nonetheless, the importance of responsive caregiving and how to coach it is often overlooked in trainings for staff in home-visiting programs.MethodsTo determine whether it is possible to enhance home-visitors' understanding of responsive caregiving and how to coach it, we conducted a cluster randomized controlled trial with 181 staff working in Brazil's national home-visiting program. We used a computerized random number generator to randomly assign half of participants to take an online professional development course about responsive caregiving immediately and the other half to a waitlist. Individuals assessing outcome data were blind to group assignment.ResultsCompared to those in the control group (N = 90, both randomized and analyzed), participants assigned to take the course (N = 91, both randomized and analyzed) were more knowledgeable about responsivity (Cohen's d = 0.64, 95% Confidence Interval (CI) = 0.34, 0.94) and its importance for children's socioemotional (odds ratio (OR) = 1.88, 95% CI = 1.00, 3.50) and cognitive (OR = 2.57, 95% CI = 1.15, 5.71) development, better able to identify responsive parental behaviors in videotaped interactions (d = 1.86, 95% CI = 1.51, 2.21), and suggested more effective strategies for coaching parents on responsivity (d = 0.51, 95% CI = 0.21, 0.80) and tracking goal implementation (OR = 3.20, 95% CI = 1.28, 7.99). There were no significant changes in participants' tendency to encourage goal setting and reflection, or their perspective-taking skills. Participants were very satisfied with the course content and mode of delivery and there was no drop-out from the program.ConclusionsA short, online professional development program created moderate to large improvements in home-visitors' knowledge and intended coaching practices. This suggests that such programs are feasible, even in low-income and rural areas, and provide a low-cost, scalable option for possibly maximizing the impact of home-visiting programs - particularly with regard to parental responsivity, and in turn, child outcomes.
| S-EPMC8818297 | biostudies-literature
Project description:BackgroundInternet-based treatment programs present a solution for providing access to pain management for those unable to access clinic-based multidisciplinary pain programs. Attrition from internet interventions is a common issue. Clinician-supported guidance can be an important feature in web-based interventions; however, the optimal level of therapist guidance and expertise required to improve adherence remains unclear.ObjectiveThe aim of this study is to evaluate whether augmenting the existing Reboot Online program with telephone support by a clinician improves program adherence and effectiveness compared with the web-based program alone.MethodsA 2-armed, CONSORT (Consolidated Standards of Reporting Trials)-compliant, registered randomized controlled trial with one-to-one group allocation was conducted. It compared a web-based multidisciplinary pain management program, Reboot Online, combined with telephone support (n=44) with Reboot Online alone (n=45) as the control group. Participants were recruited through web-based social media and the This Way Up service provider network. The primary outcome for this study was adherence to the Reboot Online program. Adherence was quantified through three metrics: completion of the program, the number of participants who enrolled into the program, and the number of participants who commenced the program. Data on adherence were collected automatically through the This Way Up platform. Secondary measures of clinical effectiveness were also collected.ResultsReboot Online combined with telephone support had a positive effect on enrollment and commencement of the program compared with Reboot Online without telephone support. Significantly more participants from the Reboot Online plus telephone support group enrolled (41/44, 93%) into the course than those from the control group (35/45, 78%; χ21=4.2; P=.04). Furthermore, more participants from the intervention group commenced the course than those from the control group (40/44, 91% vs 27/45, 60%, respectively; χ21=11.4; P=.001). Of the participants enrolled in the intervention group, 43% (19/44) completed the course, and of those in the control group, 31% (14/45) completed the course. When considering the subgroup of those who commenced the program, there was no significant difference between the proportions of people who completed all 8 lessons in the intervention (19/40, 48%) and control groups (14/27, 52%; χ21=1.3; P=.24). The treatment efficacy on clinical outcome measures did not differ between the intervention and control groups.ConclusionsTelephone support improves participants' registration, program commencement, and engagement in the early phase of the internet intervention; however, it did not seem to have an impact on overall course completion or efficacy.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12619001076167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001076167.
| S-EPMC8855305 | biostudies-literature
Project description:BACKGROUND:Pain is a common public health concern, and the pain situation among the general population is serious in mainland China. Working adults commonly experience pain because of long sitting times, a lack of free time, and exercise. A lack of pain-related knowledge is also a significant factor. Educational and therapeutic programs delivered online were used more often in Western countries, and accessible programs in China are limited, especially for pain management. Therefore, we carried out an online pain education program for working adults to self-manage pain. The program was delivered through WeChat, a popular and secure social media with a large population base in China. OBJECTIVE:This study aimed to (1) provide pain-related knowledge and self-relief strategies, (2) help participants reduce pain and improve pain-related emotional well-being, and (3) explore participants' learning performance and the acceptability of the online pain education program. METHODS:This was a randomized controlled trial. Chinese adults aged between 16 and 60 years with full-time employment, with pain in the past 6 months, and without any mental illness were recruited using snowball sampling through the internet and were randomly allocated to an experimental group and a control group in 1:1 ratio after the baseline assessment. The 4-week educational program that included basic knowledge of pain, pharmacological and nonpharmacological treatments, and related resources was provided only to the experimental group. Outcomes of pain, depression, anxiety, stress, and pain self-efficacy were measured at baseline (T0), posttreatment (T1), and 1-month follow-up (T2). Participants' acceptability and satisfaction were explored after completing the educational program. RESULTS:In total, 95 eligible participants joined in the program: 47 in the experimental group and 48 in the control group. Neck and shoulder, head, and back were most commonly reported pain sites with high pain scores. Pain intensity and interference of the experimental group were significantly reduced after the educational program. Depression, anxiety, and stress clinically improved and pain self-efficacy improved after the educational program. The difference in depression, anxiety, stress, and pain self-efficacy within a group or between groups was not statistically significant; however, clinical improvements were demonstrated. A significant correlation between dosage of the intervention and pain intensity and depression was demonstrated. After completing the educational program, more than half of the participants showed acceptance of and satisfaction with the program, and they were willing to recommend the program to others. CONCLUSIONS:Our findings highlight the significant potential of this online education program in the treatment of pain. TRIAL REGISTRATION:ClinicalTrials.gov NCT03952910; https://clinicaltrials.gov/ct2/show/NCT03952910.
| S-EPMC6996734 | biostudies-literature
Project description:BackgroundDue to budget restrictions in mental health care, non-professional caregivers are increasingly burdened with the emotional and practical care for their depressed relatives. However, informal family caregiving is mostly a stressful role with negative consequences on the physical and mental health of the caretakers to the extent that they have an elevated risk of experiencing psychiatric disorders themselves. While psychoeducation for relatives of depressed individuals showed positive results both in terms of the caretakers' strain and the depressive symptoms of the affected person, there are major barriers to participate in presence in those programs. Digital programs might be a viable alternative. We found no empirically evaluated digital program available for informal caregivers of depressed patients.MethodsAn online program for relatives of depressed individuals has been developed including four interactive modules on 1) psychoeducation, 2) how to strengthen the relationship with the depressed person, 3) how to deal with the depressive symptoms of the patient, and 4) find the right balance between caring for the depressed person and self-care. We investigate if this self-help program is more effective when used with individualized versus automated e-mail support, and if both supported conditions are more effective than treatment-as-usual (TAU in form of written information material) in terms of the risk of mental diseases in caregivers. The primary outcome is the reduction of the caregiver's nonspecific mental distress as measured by the change of the Kessler Psychological Distress Scale score from baseline to four weeks after randomization. Caregivers (n = 500:500:250) will be randomized to one of the three conditions.DiscussionPsychological support for caregivers of individuals with mental disorders such as depression should be offered as part of integrated services. There is a huge potential to develop and implement interactive online approaches to support informal caregivers of patients with depression to function in their multiple roles and to help them to remain healthy.Trial registrationDRKS, DRKS00025241 . Registered 5 Mai 2021.
| S-EPMC9331487 | biostudies-literature
Project description:Chronic stress affects many Americans. Stress management programs may be prohibitively expensive or have limited access.This study aims to determine feasibility of an 8-week Internet-based stress management program (ISM) based on mindfulness principles in reducing stress in a 12-week, parallel, randomized, controlled trial.Participants were randomly allocated to ISM, ISM plus online message board (ISM+), or control groups. Perceived stress, mindfulness, self-transcendence, psychological well-being, vitality, and quality of life were measured at baseline, week 8, and week 12 using standard validated questionnaires.ISM and ISM+ groups demonstrated statistically significant improvements compared with control on all measures except vitality and physical health.The ISM program effectively and sustainably reduced measures of stress. The magnitude of improvement is comparable to traditional mindfulness programs, although fewer participants were engaged. This feasibility study provides strong support for online stress management programs, which increase access at a fraction of cost of traditional programs.
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