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Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). OBJECTIVE:The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. METHODS:A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. RESULTS:Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample size of 99. The MMR+WEB intervention was effective over time (time*group) compared to MMR for the two-item CSQ catastrophizing subscale (P=.003), with an effect size of 0.61 (Cohen d) at 12 months. There were no significant between-group differences over time (time*group) regarding pain intensity, self-efficacy (pain, other symptoms, and general), or regarding six subscales of the two-item CSQ. Improvements over time (time) for the whole study group were found regarding mean (P<.001) and maximum (P=.002) pain intensity. The mean time spent in the Web-based program was 304 minutes (range 0-1142). Participants rated the items of Web-BCPA feasibility between 68/100 and 90/100. Participants in the MMR+WEB group were more satisfied with their MMR at 4 months (P<.001) and at 12 months (P=.003). CONCLUSIONS:Adding a self-guided Web-based intervention with a focus on behavioral change for activity to MMR can reduce catastrophizing and increase satisfaction with MMR. Patients in MMR may need more supportive coaching to increase adherence in the Web-BCPA to find it valuable. CLINICALTRIAL:Clinicaltrials.gov NCT01475591; https://clinicaltrials.gov/ct2/show/NCT01475591 (Archived by WebCite at http://www.webcitation.org/6kUnt7VQh).

SUBMITTER: Nordin CA

PROVIDER: S-EPMC5071618 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial.

Nordin Catharina A CA Michaelson Peter P Gard Gunvor G Eriksson Margareta K MK

Journal of medical Internet research 20161005 10

<h4>Background</h4>Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR).<h4>Objective</h4>The objective of our study was to evaluate the ...[more]

PMID: 27707686

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Project description:BackgroundPatients' participation in their health care is recognized as a key component in high-quality health care. Persons with persistent pain are recommended treatments with a cognitive approach from a biopsychosocial explanation of pain, in which a patient's active participation in their rehabilitation is in focus. Web-based interventions for pain management have the potential to increase patient participation by enabling persons to play a more active role in rehabilitation. However, little is known about patients' experiences of patient participation in Web-based interventions in clinical practice.ObjectiveThe objective of our study was to explore patients' experiences of patient participation in a Web Behavior Change Program for Activity (Web-BCPA) in combination with multimodal rehabilitation (MMR) among patients with persistent pain in primary health care.MethodsQualitative interviews were conducted with 15 women and 4 men, with a mean age of 45 years. Data were analyzed with qualitative content analysis.ResultsOne theme, "It's about me," and 4 categories, "Take part in a flexible framework of own priority," "Acquire knowledge and insights," "Ways toward change," and "Personal and environmental conditions influencing participation," were developed. Patient participation was depicted as being confirmed in an individualized and structured rehabilitation framework of one's own choice. Being confirmed was fundamental to patient participation in the interaction with the Web-BCPA and with the health care professionals in MMR. To acquire knowledge and insights about pain and their life situation, through self-reflection in the solitary work in the Web-BCPA and through feedback from the health care professionals in MMR, was experienced as patient participation by the participants. Patient participation was described as structured ways to reach their goals of behavior change, which included analyzing resources and restrictions, problem solving, and evaluation. The individual's emotional and cognitive resources and restrictions, as well as health care professionals and significant others' attitudes and behavior influenced patient participation in the rehabilitation. To some extent there were experiences of restrained patient participation through the great content of the Web-BCPA.ConclusionsPatient participation was satisfactory in the Web-BCPA in combination with MMR. The combined treatment was experienced to increase patient participation in the rehabilitation. Being confirmed through self-identification and finding the content of the Web-BCPA trustworthy was emphasized. Patient participation was experienced as a learning process leading to new knowledge and insights. Higher user control regarding the timing of the Web-BCPA and therapist guidance of the content may further increase patient participation in the combined treatment.

Project description:Internet-delivered interventions hold the possibility to make pain rehabilitation more accessible and adaptable by providing qualified individualized psychological care to chronic pain patients in their homes. Acceptance and commitment therapy (ACT) has shown promising results on psychological functioning and pain acceptance. Internet-delivered ACT (IACT) added to multimodal pain rehabilitation program (MMRP) in primary care has, so far, not shown better results than MMRP alone. The aim of this cluster randomized controlled study was to investigate the effects of adding IACT during and after MMRP in specialist care on psychological outcomes. In total, 122 patients who enrolled in a specialist pain clinic were cluster randomized groupwise to either MMRP (n = 12 groups) or to MMRP with added IACT (n = 12 groups). The IACT addition included 6 weeks of treatment during MMRP and 11 weeks of aftercare following MMRP. Online and paper-and-pencil self-report measures of pain acceptance, psychological inflexibility, self-efficacy, and psychosocial consequences of pain, were collected at four occasions: prior to and post MMRP, post aftercare intervention and at 1 year follow-up. Dropout was extensive with 25% dropping out at post treatment, an additional 35% at post aftercare, and 29% at 1 year follow-up. Medium treatment between-group effects were found on pain acceptance in favor of the group who received IACT added to MMRP, at post treatment and at post aftercare. Large effects were seen on psychological inflexibility and self-efficacy at post aftercare. A medium effect size was seen on affective distress at post aftercare. Moreover, a medium effect on self-efficacy was found at 1 year follow-up. The results indicate that IACT added during MMRP may enhance the treatment effects on pain-related psychological outcomes. Results also suggest that IACT as aftercare may strengthen the long-term effect of MMRP. However, adding a second pain treatment, IACT, to an already extensive pain treatment, MMRP, could be perceived as too comprehensive and might hence influence completion negatively. Further research on adverse events and negative effects could be helpful to improve adherence. Next step of implementation trials could focus on adding IACT before MMRP to improve psychological functioning and after MMRP to prolong its effect.

Project description:BackgroundChronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual.Methods/designPragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, β = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations.DiscussionA pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice.Trial registrationClinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante.

Project description:BackgroundThe effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear.ObjectiveWe aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity.MethodsThis pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes.ResultsAmong the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).ConclusionsThe web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss.Trial registrationClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445.International registered report identifier (irrid)RR2-10.2196/10.1186/s12889-018-5882-y.

Project description:BackgroundChronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities.ObjectiveThe aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial.MethodsAn unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting.ResultsOnly 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up-characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=-2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=-3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001).ConclusionsThis study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible.Trial registrationClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762.

Project description:Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors.The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors.Participants (n=352) were recruited from oncology clinics, a tumor registry, as well as through online mechanisms, such as Facebook and the Association of Cancer Online Resources (ACOR). Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment. Participants were randomly assigned to the Web-based program or a delayed-treatment control condition.In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls. There were no significant changes in fruit and vegetable consumption or other outcomes.The Web-based intervention impacted insomnia and exercise; however, a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Thus, the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited. Future work is discussed, with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit, such as in regard to social networking.Clinicaltrials.gov NCT00962494; http://www.clinicaltrials.gov/ct2/show/NCT00962494 (Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q).

Project description:BackgroundFamily carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE) designed to facilitate positive carepartner involvement during a home-based application of constraint-induced movement therapy (CIMT) for the upper extremity.MethodsThe primary aim of the study is to determine feasibility of CARE-CITE for both stroke survivors and their carepartners. Carepartner mental health, family conflict surrounding stroke recovery, and stroke survivor upper extremity function will be evaluated using an evaluator blinded, two-group experimental design (blocked randomization protocol according to a 2:1 randomization schema) with 32 intervention dyads and 16 control dyads (who will receive CIMT without structured carepartner involvement). CARE-CITE consists of online education modules for the carepartner to review in parallel to the 30-h CIMT that the stroke survivor receives. The intent of CARE-CITE is to enhance the home-based intervention of CIMT, by helping the carepartner support the therapy and create a therapeutic home environment encouraging practice of the weaker arm in functional tasks.DiscussionThe CARE-CITE study is testing the feasibility of a family-integrated rehabilitation approach applied in the home environment, and results will provide the foundation for larger clinical studies. The overall significance of this research plan is to increase the understanding and further development of interventions that may serve as models to promote family involvement in the rehabilitation process.Trial registrationClinicalTrials.gov, NCT02703532. Registered 9 March 2016.

Project description:BackgroundActive transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking.ObjectiveThe goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA).MethodsFor this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months.ResultsNo effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day.ConclusionsNo effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA.Trial registrationClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837.International registered report identifier (irrid)RR2-10.1186/s12889-018-5658-4.

Dataset Information

Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial.

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Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial.

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