Dataset Information

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

ABSTRACT: INTRODUCTION:Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Commitment Therapy (ACT) might be a promising alternative for this population and may enable effective treatment of chronic pain. The present study aims to evaluate the clinical and cost-effectiveness of an ACT-based IMI for chronic pain in green professions in comparison with enhanced treatment as usual (TAU+). METHODS AND ANALYSIS:A two-armed pragmatic randomised controlled trial will be conducted. Two hundred eighty-six participants will be randomised and allocated to either an intervention or TAU+ group. Entrepreneurs in green professions, collaborating spouses, family members and pensioners with chronic pain are eligible for inclusion. The intervention group receives an internet-based intervention based on ACT (7 modules, over 7 weeks) guided by a trained e-coach to support adherence (eg, by positive reinforcement). Primary outcome is pain interference (Multidimensional Pain Interference scale; MPI) at 9?weeks post-randomisation. Secondary outcomes are depression severity (Quick Inventory Depressive Symptomology; QIDS-SR16), incidence of major depressive disorder, quality of life (Assessment of Quality of Life; AQoL-8D) and possible side effects associated with the treatment (Inventory for the Assessment of Negative Effects of Psychotherapy; INEP). Psychological flexibility (Chronic Pain Acceptance Questionnaire, Committed Action Questionnaire, Cognitive Fusion Questionnaire) will be evaluated as a potential mediator of the treatment effect. Furthermore, mediation, moderation and health-economic analyses from a societal perspective will be performed. Outcomes will be measured using online self-report questionnaires at baseline, 9-week, 6-month, 12-month, 24-month and 36-month follow-ups. ETHICS AND DISSEMINATION:This study was approved by the Ethics Committee of the University of Ulm, Germany (file no. 453/17-FSt/Sta; 22 February 2018). Results will be submitted for publication in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER:German Clinical Trial Registration: DRKS00014619. Registered on 16 April 2018.

SUBMITTER: Terhorst Y

PROVIDER: S-EPMC7473633 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

Terhorst Yannik Y Braun Lina L Titzler Ingrid I Buntrock Claudia C Freund Johanna J Thielecke Janika J Ebert David D Baumeister Harald H

BMJ open 20200903 9

<h4>Introduction</h4>Chronic pain is highly prevalent, associated with substantial personal and economic burdens, and increased risk for mental disorders. Individuals in green professions (agriculturists, horticulturists, foresters) show increased prevalence of chronic pain and other risk factors for mental disorders. Available healthcare services in rural areas are limited. Acceptance towards face-to-face therapy is low. Internet and mobile-based interventions (IMIs) based on Acceptance and Com ...[more]

PMID: 32883721

Similar Datasets

Project description:BackgroundInternet-based interventions (IBIs) are effective for the prevention and treatment of mental disorders and are valuable additions for improving routine care. However, the uptake of and adherence to IBIs are often limited. To increase the actual use of IBIs, it is important to identify factors for engaging with and adhering to IBIs.ObjectiveWe qualitatively evaluated barriers and facilitators regarding a portfolio of guided IBIs in green professions (farmers, gardeners, and foresters).MethodsInterview participants were selected from 2 randomized controlled trials for either the prevention of depression (Prevention of Depression in Agriculturists [PROD-A]) or the reduction of pain interference (Preventive Acceptance and Commitment Therapy for Chronic Pain in Agriculturists [PACT-A]) in green professions. The intervention group in PROD-A (N=180) participated in an IBI program, receiving access to 1 of 6 symptom-tailored IBIs. The intervention group in PACT-A (N=44) received access to an IBI for chronic pain. Overall, 41 semistructured qualitative interviews were conducted and transcribed verbatim. Barriers and facilitators were identified via inductive qualitative content analysis, with 2 independent coders reaching almost perfect intercoder reliability (Cohen κ=0.92). A quantitative follow-up survey (30/41, 73%) was conducted to validate the results. Subgroup analyses were performed based on intervention characteristics.ResultsWe identified 42 barriers and 26 facilitators, which we assigned to 4 superordinate categories related to the intervention (20 barriers; 17 facilitators), work (4 barriers; 1 facilitator), individual (13 barriers; 8 facilitators), and technical (5 barriers; 0 facilitators) aspects. Key barriers (identified by at least 50% of the interviewees) were time-consuming work life (29/40, 73%) and time-consuming private life (23/40, 58%). Similarly, the most frequently identified facilitators included presence of motivation, curiosity, interest and perseverance (30/40, 75%), flexible time management at work (25/40, 63%), and support from family and friends (20/40, 50%). Although agreement with barriers in the quantitative follow-up survey was rather low (mean 24%, SD 11%), agreement with facilitators was substantially higher (mean 80%, SD 13%). Differences in agreement rates were found particularly between intervention completers and noncompleters. Completers agreed significantly more often that perceived IBI success; being motivated, curious, interested, and perseverant; and having a persisting level of psychological strain have been facilitating. Noncompleters agreed more often with experiencing the e-coach contact as insufficient and technical problems as hindering for intervention completion.ConclusionsBased on these results, strategies such as customization of modules for more flexible and adaptive use; video chat options with the e-coach; options to facilitate social support by family, friends, or other participants; or using prompts to facilitate training completion can be derived. These approaches could be evaluated in further quantitative research designs in terms of their potential to enhance intervention use in this occupational group.Trial registrationGerman Clinical Trials Register DRKS00014000, https://tinyurl.com/3bukfr48; German Clinical Trials Register DRKS0001461, https://tinyurl.com/ebsn4sns.

Project description:BackgroundHealth anxiety is a prevalent and debilitating disorder associated with extensive use of healthcare services and reduced quality of life (QoL). Regional variability in specialised clinics or specialist healthcare providers limits access to evidence-based treatment, which may be overcome by internet-delivered Acceptance and Commitment Therapy (iACT).ObjectiveThis study investigated the cost effectiveness of iACT for severe health anxiety in adults.MethodsBased on a Danish randomised controlled trial (March 2016-March 2017), the economic evaluation compared costs and effects between iACT and an active control condition (iFORUM). Effectiveness was measured using self-report questionnaires. The cost analysis applied a societal perspective. Resource use and healthcare costs were extracted from the Danish National Registries. Linear regression analysis was applied using change in costs/effectiveness outcomes as the dependant variable. Time, group, and interaction between time and group were independent variables. The primary outcome was the proportion of clinically significant improvements, defined as a ≥ 25% reduction in two measures of health anxiety. The probability of cost effectiveness was presented in a cost-effectiveness acceptability curve for a range of threshold values for willingness to pay.ResultsNo significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes. The economic analysis showed that, from the healthcare perspective, iACT was associated with an incremental cost-effectiveness ratio of €33 per additional case of clinically significant improvement compared with iFORUM and that, from the societal perspective, iACT dominated iFORUM because it was more effective and less expensive.ConclusionsWe found no statistically significant differences in costs between groups; however, iACT for severe health anxiety may be cost effective, as evidenced by significant differences in effect.Trial registry numberClinicaltrials.gov, no. NCT02735434.

Project description:BACKGROUND:Anxiety conditions are debilitating and prevalent throughout the world. Acceptance and Commitment Therapy (ACT) is an effective, acceptance-based behavioral therapy for anxiety. However, there are treatment barriers (eg, financial, geographical, and attitudinal), which prevent people from accessing it. To overcome these barriers, internet-delivered ACT (iACT) interventions have been developed in recent years. These interventions use websites to deliver ACT information and skill training exercises on the Web, either as pure self-help or with therapist guidance. OBJECTIVE:This systematic review aimed to examine the therapeutic impact of iACT on all anxiety conditions. METHODS:The EMBASE, MEDLINE, ProQuest Central, PsycINFO, Scopus, and Web of Science databases were searched up to September 2018. The titles and abstracts of remaining records after deduplication were screened by 2 authors with a total of 36 full-text articles being retained for closer inspection next to eligibility criteria. Empirical studies of all designs, population types, and comparator groups were included if they appraised the impact of iACT treatment on any standardized measure of anxiety. Included studies were appraised on methodological quality and had their data extracted into a standardized coding sheet. Findings were then tabulated, and a narrative synthesis was performed because of the heterogeneity found between studies. RESULTS:A total of 20 studies met inclusion criteria. There were 11 randomized controlled trials (RCTs) and 9 uncontrolled pilot studies. Participants across all studies were adults. The anxiety conditions treated were as follows: generalized anxiety disorder (GAD), social anxiety disorder (SAD), illness anxiety disorder (IAD), and general anxiety symptoms, with or without comorbid physical and mental health problems. A total of 18 studies reported significant anxiety reduction after iACT treatment. This was observed in studies that delivered iACT with (n=13) or without (n=5) therapist guidance. The average attrition rate across all included studies during the active iACT treatment phase was 19.19%. In the 13 studies that assessed treatment satisfaction, participants on average rated their iACT experience with above average to high treatment satisfaction. CONCLUSIONS:These findings indicate that iACT can be an efficacious and acceptable treatment for adults with GAD and general anxiety symptoms. More RCT studies are needed to corroborate these early iACT findings using empirical treatments in active control groups (eg, internet-delivered cognitive behavioral therapy). This would potentially validate the promising results found for SAD and IAD as well as address the full spectrum of anxiety disorders.

Project description:Severe health anxiety (hypochondriasis), or illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, is characterized by preoccupation with fear of suffering from a serious illness in spite of medical reassurance. It is a debilitating, prevalent disorder associated with increased health care utilization. Still, there is a lack of easily accessible specialized treatment for severe health anxiety.The aims of this paper were to (1) describe the development and setup of a new internet-delivered acceptance and commitment therapy (iACT) program for patients with severe health anxiety using self-referral and a video-based assessment; and (2) examine the feasibility and potential clinical efficacy of iACT for severe health anxiety.Self-referred patients (N=15) with severe health anxiety were diagnostically assessed by a video-based interview. They received 7 sessions of clinician-supported iACT comprising self-help texts, video clips, audio files, and worksheets over 12 weeks. Self-report questionnaires were obtained at baseline, post-treatment, and at 3-month follow-up. The primary outcome was Whiteley-7 Index (WI-7) measuring health anxiety severity. Depressive symptoms, health-related quality of life (HRQoL), life satisfaction, and psychological flexibility were also assessed. A within-group design was employed. Means, standard deviations, and effect sizes using the standardized response mean (SRM) were estimated. Post-treatment interviews were conducted to evaluate the patient experience of the usability and acceptability of the treatment setup and program.The self-referral and video-based assessments were well received. Most patients (12/15, 80%) completed the treatment, and only 1 (1/15, 7%) dropped out. Post-treatment (14/15, 93%) and 3-month follow-up (12/15, 80%) data were available for almost all patients. Paired t tests showed significant improvements on all outcome measures both at post-treatment and 3-month follow-up, except on one physical component subscale of HRQoL. Health anxiety symptoms decreased with 33.9 points at 3-month follow-up (95% CI 13.6-54.3, t11= 3.66, P=.004) with a large within-group effect size of 1.06 as measured by the SRM.Treatment adherence and potential efficacy suggest that iACT may be a feasible treatment for health anxiety. The uncontrolled design and small sample size of the study limited the robustness of the findings. Therefore, the findings should be replicated in a randomized controlled trial. Potentially, iACT may increase availability and accessibility of specialized treatment for health anxiety.Danish Data Protection Agency, Central Denmark Region: 1-16-02-427-14; https://www.rm.dk/sundhed/faginfo/forskning/datatilsynet/ (Archived by Webcite at http://www.webcitation.org/6yDA7WovM).

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.

Dataset Information

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

Publications

Clinical and cost-effectiveness of a guided internet-based Acceptance and Commitment Therapy to improve chronic pain-related disability in green professions (PACT-A): study protocol of a pragmatic randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets