Work-related medical rehabilitation in patients with mental disorders: the protocol of a randomized controlled trial (WMR-P, DRKS00023175).
Ontology highlight
ABSTRACT: Background
Various rehabilitation services and return-to-work programs have been developed in order to reduce sickness absence and increase sustainable return-to-work. To ensure that people with a high risk of not returning to work can participate in working life, the model of work-related medical rehabilitation was developed in Germany. The efficacy of these programs in patients with mental disorders has been tested in only a few trials with very specific intervention approaches. To date, there is no clear evidence of the effectiveness of work-related medical rehabilitation implemented in real-care practice.Methods/design
Our randomized controlled trial will be conducted in six rehabilitation centers across Germany. Within 15 months, 1800 patients with mental disorders (300 per rehabilitation center) will be recruited and assigned one-to-one either to a work-related medical rehabilitation program or to a conventional psychosomatic rehabilitation program. Participants will be aged 18-60 years. The control group will receive a conventional psychosomatic rehabilitation program without additional work-related components. The intervention group will receive a work-related medical rehabilitation program that contains at least 11 h of work-related treatment modules. Follow-up data will be assessed at the end of the rehabilitation and 3 and 12 months after completing the rehabilitation program. The primary outcome is a stable return to work. Secondary outcomes cover several dimensions of health, functioning and coping strategies. Focus groups and individual interviews supplement our study with qualitative data.Discussion
This study will determine the relative effectiveness of a complex and newly implemented work-related rehabilitation strategy for patients with mental disorders.Trial registration
German Clinical Trials Register ( DRKS00023175 , September 29 2020).
SUBMITTER: Markus M
PROVIDER: S-EPMC8091693 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundRetraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity.ObjectiveThe aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes).MethodsWe conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes.ResultsThis study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022).ConclusionsThe findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation.International registered report identifier (irrid)DERR1-10.2196/50200.
| S-EPMC10985606 | biostudies-literature
Project description:Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group.The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18-60 years, on sick leave 2-12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter "untouched" control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½?weeks with full rehabilitation days. The Short program consists of 4?+?4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods.ClinicalTrials.gov: NCT01926574.
| S-EPMC3996166 | biostudies-literature
Project description:Medical certification is one of the basic administrative mechanisms used by social policies aimed at income protection. The assessment of work disability is central to the income protection application. Yet, there is evidence suggesting that determining work disability related to mental disorders is challenging. Although essential to the disability application process, few studies have looked at physician and other clinician experiences with the process. However, this type of information is critical to developing processes to support providers who participate in the assessments. This purpose of this paper is to explore the experiences of physicians and other clinicians assessing public long-term work disability related to mental disorders.This is an exploratory and descriptive study using qualitative methods. Clinician input was gathered through focus groups and individual in-depth interviews. Verbatim transcripts were analyzed to identify recurrent and significant themes that arose during the focus groups and individual interviews.Many of the experiences that the clinicians in this sample discussed related to the difficulty of trying to fill the roles of advocate and medical expert as well as the challenge of determining the impact of functional capacity and work ability. The findings also highlight the current gap in knowledge about the factors that affect successful functioning in general and at work in particular.Given the challenges created by the current state of knowledge, it may be useful to consider a category of "partial disability". In addition, the fact that work disability depends on the interaction between the experience of the mental disorder and specific job requirements and the fact that people applying for public long-term disability are not working, it might be helpful to offer a clear description and guidelines of the meaning of work ability.
| S-EPMC4366073 | biostudies-other
Project description:BackgroundLoss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non-free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD.ObjectiveThis study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms.MethodsIn this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months.ResultsEthical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants' recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement.ConclusionsThe purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management.Trial registrationClinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381.International registered report identifier (irrid)DERR1-10.2196/33104.
| S-EPMC8742205 | biostudies-literature
Project description:PurposeCommon mental disorders (CMDs) are major causes of sickness absence and disability. Prevention requires knowledge of how individuals perceive causal mechanisms, and in this study we sought to examine work-related factors as causal attribution of CMDs.MethodsA trial sample of n = 1,193, recruited because they struggled with work participation due to CMDs, answered an open-ended questionnaire item about what they believed were the most important causes of their CMDs. The population included participants at risk of sickness absence, and participants with reduced work participation due to sickness absence, disability or unemployment. We used thematic content analysis and categorized responses from 487 participants who reported work-related factors as causal attributions of their CMDs. Gender differences in work-related causal attributions were also examined.ResultsThe participants attributed their CMDs to the following work-related factors; work stress, leadership, reduced work participation, job dissatisfaction, work conflict, social work environment, job insecurity and change, workplace bullying, and physical strain. Women tended to attribute CMDs to social factors at work.ConclusionFindings from this study suggest several work-related risk factors for CMDs. Both factors at the workplace, and reduced work participation, were perceived by study participants as contributing causes of CMDs. Thus, there is a need to promote work participation whilst at the same time targeting aversive workplace factors. Further, our findings indicate that work-related factors may affect women and men differently. This illustrates that the association between work participation and CMDs is complex, and needs to be explored further.
| S-EPMC4540770 | biostudies-literature
Project description:BackgroundWork-related stress has become a major challenge for social security and health care systems, employers and employees across Europe. In Sweden, sickness absence particularly due to stress-related disorders has increased excessively in recent years, and the issue of how to improve sustainable return to work in affected employees is high up on the political agenda. The literature on interventions for return to work in patients with common mental disorders is still inconclusive. This randomized controlled trial (RCT) aims to contribute with knowledge about how physicians and rehabilitation coordinators in primary health care can involve the employer in the rehabilitation of patients with stress-related disorders. The objective is to evaluate whether the early involvement of the patient's employer can reduce the time for return to work compared to treatment as usual. A process study will complete the RCT with information about what prerequisites primary health caregivers need to succeed with this endeavor.MethodsTwenty-two primary care centers were randomized to either intervention or control group. At the intervention centers, physicians and rehabilitation coordinators underwent training, providing them with both knowledge and practical tools to involve the employer in rehabilitation. At the patient level, employed patients with an ICD-10 F43 diagnosis were eligible for participation (n=132). Difference in proportion of patients on full- or part-time sick leave at three, six and 12 months after inclusion will be investigated. Register data, logbooks and interviews with coordinators and physicians at both intervention and control centers will be used for process evaluation.DiscussionAlthough the issue of how to tackle work-related stress can be recognized all across Europe, Sweden face an urgent need to curb the disproportional increase of stress-related disorders in the sick-leave statistics. Since physicians are limited by time constraints, the rehabilitation coordinator may be a helpful resource to take this contact. The current study will contribute to knowledge about how this collaboration can be organized to facilitate employer involvement and reduce time to return to work among patients suffering from work related stress.Trial registrationRegistered on 1 November 2016, ClinicalTrials.gov, NCT03022760 .
| S-EPMC6034234 | biostudies-literature
Project description:BackgroundCommon mental disorders are one of the leading causes for sickness absence and early retirement due to reduced health. Furthermore, a treatment gap for common mental disorders has been described worldwide. Within this study, psychotherapeutic consultation at work defined as a tailored, module-based and work-related psychotherapeutic intervention will be applied to improve mental health care.MethodsThis study comprises a randomised controlled multicentre trial with 1:1 allocation to an intervention and control group. In total, 520 employees with common mental disorders shall be recruited from companies being located around five study centres in Germany. Besides care as usual, the intervention group will receive up to 17 sessions of psychotherapy. The first session will include basics diagnostics and medical indication of treatment and the second session will include work-related diagnostics. Then, participants of the intervention group may receive work-related psychotherapeutic consultation for up to ten sessions. Further psychotherapeutic consultation during return to work for up to five sessions will be offered where appropriate. The control group will receive care as usual and the first intervention session of basic diagnostics and medical indication of treatment. After enrolment to the study, participants will be followed up after nine (first follow-up) and fifteen (second follow-up) months. Self-reported days of sickness absence within the last 6 months at the second follow-up will be used as the primary outcome and self-efficacy at the second follow-up as the secondary outcome. Furthermore, a cost-benefit assessment related to costs of common mental disorders for social insurances and companies will be performed.DiscussionPsychotherapeutic consultation at work represents a low threshold care model aiming to overcome treatment gaps for employees with common mental disorders. If successfully implemented and evaluated, it might serve as a role model to the care of employees with common mental disorders and might be adopted in standard care in cooperation with sickness and pension insurances in Germany.Trial registrationThe friaa project was registered at the German Clinical Trial Register (DRKS) at 01.03.2021 (DRKS00023049): https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023049 .
| S-EPMC8218449 | biostudies-literature
Project description:Objectives: Work-related mental distress is one of the most dominant reasons for sick leave and early retirement. Specialized therapy programs for work-related mental health problems are rare, especially in a group setting. This study evaluates the severity of depression, anxiety, somatization and burnout symptoms before and after a work-related group therapy program. Methods: Patients of a psychosomatic outpatient clinic with work-related mental disorders completed 12 sessions of a manual-based group training with reference to the workplace. Data were collected using the Patient Health Questionnaire-9 (PHQ-9), Patient Health Questionnaire-15 (PHQ-15), General Anxiety Disorder Scale-7 (GAD-7) and the Maslach Burnout Inventory (MBI) before (T1) and directly after the intervention (T2). Results: Overall, 48 participants completed the intervention. The participants' symptoms of depression (T1: M = 11.06, SD = 6.19, T2: M = 8.92, SD = 8.17; p < 0.001, d = 0.53) and anxiety (T1: M = 9.94, SD = 5.18, T2: M = 7.13, SD = 5.69; p = 0.001, d = 0.49) as well as their emotional exhaustion (T1: M = 4.63, SD = 0.95, T2: M = 4.05, SD = 1.35; p < 0.001, d = 0.55) decreased significantly, and the difference was clinically relevant at T2. For cynicism (T1: M = 3.93, SD = 0.99, T2: M = 3.70, SD = 1.32; p = 0.14, d = 0.22) and personal fulfillment at work (T1: M = 4.30, SD = 0.83, T2: M = 4.41, SD = 0.94; p = 0.24, d = 0.17), the difference between T1 and T2 was not significant. Women benefited more than men (PHQ-9: p < 0.001, d = 0.96; GAD-7: p < 0.001, d = 0.91; PHQ-15: p < 0.001, d = 0.76) from the training. Conclusions: Participants' mental health symptoms were substantially reduced during the course of the work-related group therapy. As mental health problems account for the largest group of work disability days, the potential of group therapy should be better exploited in health care services.
| S-EPMC9915433 | biostudies-literature
Project description:BackgroundStress-related disorders have become a major challenge for society and are associated with rising levels of sick leave. The provision of support to facilitate the return to work (RTW) for this patient group is of great importance. The aim of the present study was to evaluate whether a new systematic procedure with collaboration between general practitioners (GPs), rehabilitation coordinators (RCs) and employers could reduce sick leave days for this patient group.MethodEmployed patients with stress-related diagnoses seeking care at primary health care centres (PHCCs) were included in either the intervention group (n = 54), following the systematic intervention procedure, or the control group (n = 58), receiving treatment as usual (TAU). The intervention included a) a training day for participant GPs and RCs, b) a standardised procedure for GPs and RCs to follow after training, c) the opportunity to receive clinical advice from specialist physicians in the research group. Outcome measures for RTW were sick leave days.ResultsThe median number of registered gross sick leave days was lower for the control group at six, 12 and 24 months after inclusion, but the difference was not statistically significant. The control group had significantly fewer net sick leave days at three months (p = 0.03) at six months (p = 0.00) and at 12-months follow-up (p = 0.01). At 24 months, this difference was no longer significant.ConclusionsThe PRIMA intervention, which applied a standardized procedure for employer involvement in the rehabilitation process for patients with stress-related disorders, actually increased time to RTW compared to TAU. However, at 24 months, the benefit of TAU could no longer be confirmed. The study was registered on 16/01/2017 (ClinicalTrials.gov, NCT03022760).
| S-EPMC10512560 | biostudies-literature
Project description:BackgroundIn recent decades, stress-related disorders have received more attention, with an increasing prevalence, especially within the working population. The internet provides new options for broad dissemination, and a growing body of evidence suggests that web-based interventions for stress might be effective. However, few studies have examined the efficacy of interventions in clinical samples and work-related outcomes.ObjectiveThe aim of this study was to evaluate the efficacy of an internet-based cognitive behavioral intervention for stress-related disorders integrating work-related aspects (work-focused and internet-based cognitive behavioral therapy [W-iCBT]), compared with a generic internet-based cognitive behavioral therapy (iCBT) group and a waitlist control (WLC) group.MethodsIn this trial, 182 employees, mainly employed in the health care, IT, or educational sector, who fulfilled the criteria for a stress-related disorder, were randomized to a 10-week W-iCBT (n=61, 33.5%), generic iCBT (n=61, 33.5%), or WLC (n=60, 33%). Self-rated questionnaires on perceived stress, burnout, exhaustion, and other mental health- and work-related outcomes were administered before and after the treatment and at 6- and 12-month follow-ups.ResultsCompared with the WLC group, participants of the W-iCBT and iCBT groups showed an equal and significant reduction in the primary outcome (Shirom-Melamed Burnout Questionnaire [SMBQ]) from pretreatment to posttreatment assessment (Cohen d=1.00 and 0.83, respectively) and at the 6-month follow-up (Cohen d=0.74 and 0.74, respectively). Significant moderate-to-large effect sizes were also found in the secondary health- and work-related outcomes. The W-iCBT was the only group that exhibited significant effects on work ability and short-term sickness absence. Short-term sickness absence was 445 days lower than the WLC group and 324 days lower than the iCBT intervention group. However, no significant differences were found in terms of work experience or long-term sick leave.ConclusionsThe work-focused and generic iCBT interventions proved to be superior compared with the control condition in reducing chronic stress and several other mental health-related symptoms. Interestingly, effects on work ability and short-term sickness absence were only seen between the W-iCBT intervention and the WLC groups. These preliminary results are promising, indicating that treatments that include work aspects may have the potential to accelerate recovery and reduce short-term sickness absence because of stress-related disorders.Trial registrationClinicalTrials.gov NCT05240495; https://clinicaltrials.gov/ct2/show/NCT05240495 (retrospectively registered).
| S-EPMC10170369 | biostudies-literature