scholarly journals Early intervention, treatment and rehabilitation of employees with common mental disorders by using psychotherapeutic consultation at work: study protocol of a randomised controlled multicentre trial (friaa project)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jeannette Weber ◽  
Peter Angerer ◽  
Lorena Brenner ◽  
Jolanda Brezinski ◽  
Sophia Chrysanthou ◽  
...  
Keyword(s):  
Mental Disorders ◽  
Sickness Absence ◽  
Multicentre Trial ◽  
Common Mental Disorders ◽  
Intervention Group ◽  
Control Group ◽  
Medical Indication ◽  
Work Related ◽  
Randomised Controlled

Abstract Background Common 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. Methods This 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. Discussion Psychotherapeutic 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 registration The 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.

Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial

2020 ◽  
pp. 026921552096165
Author(s):  
Inga Kröger ◽  
Corinna Nerz ◽  
Lars Schwickert ◽  
Sabine Schölch ◽  
Janina Anna Müßig ◽  
...  
Keyword(s):  
Prospective Trial ◽  
Intervention Group ◽  
Humeral Fracture ◽  
Patient Reported Outcome ◽  
Control Group ◽  
Robot Assisted ◽  
Patient Reported ◽  
Usual Therapy ◽  
Randomised Controlled

Objective: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). Design: Multicentre, assessor-blinded, randomised controlled prospective trial. Setting: Three different rehabilitation hospitals in Germany. Subjects: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). Intervention: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO®-Spring. Main measures: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. Results: The mean age of participants was 55 ± 10 years and was similar in both groups ( p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was −15 (CI = 8–22), at follow-up six month −7 (CI = −2 to 16) at follow up 13 month −9 (CI = 1–16); in control group −14 (CI = 11–18), at follow-up six month −13 (CI = 7–19) at follow up 13 month −6 (CI = −3 to 14). No difference in the change was found between groups ( p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

scholarly journals Preventing sickness absence among employees with common mental disorders or stress-related symptoms at work: a cluster randomised controlled trial of a problem-solving-based intervention conducted by the Occupational Health Services

2020 ◽  
Vol 77 (7) ◽  
pp. 454-461 ◽  
Author(s):  
Marijke Keus van de Poll ◽  
Lotta Nybergh ◽  
Caroline Lornudd ◽  
Jan Hagberg ◽  
Lennart Bodin ◽  
...  
Keyword(s):  
Mental Health ◽  
Problem Solving ◽  
Mental Disorders ◽  
Occupational Health ◽  
Sickness Absence ◽  
Primary Outcome ◽  
Common Mental Disorders ◽  
Significant Group ◽  
Secondary Outcomes

ObjectivesCommon mental disorders (CMDs) are among the main causes of sickness absence and can lead to suffering and high costs for individuals, employers and the society. The occupational health service (OHS) can offer work-directed interventions to support employers and employees. The aim of this study was to evaluate the effect on sickness absence and health of a work-directed intervention given by the OHS to employees with CMDs or stress-related symptoms.MethodsRandomisation was conducted at the OHS consultant level and each consultant was allocated into either giving a brief problem-solving intervention (PSI) or care as usual (CAU). The study group consisted of 100 employees with stress symptoms or CMDs. PSI was highly structured and used a participatory approach, involving both the employee and the employee’s manager. CAU was also work-directed but not based on the same theoretical concepts as PSI. Outcomes were assessed at baseline, at 6 and at 12 months. Primary outcome was registered sickness absence during the 1-year follow-up period. Among the secondary outcomes were self-registered sickness absence, return to work (RTW) and mental health.ResultsA statistical interaction for group × time was found on the primary outcome (p=0.033) and PSI had almost 15 days less sickness absence during follow-up compared with CAU. Concerning the secondary outcomes, PSI showed an earlier partial RTW and the mental health improved in both groups without significant group differences.ConclusionPSI was effective in reducing sickness absence which was the primary outcome in this study.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Body mass index and physical activity in seven-year-old children whose mothers exercised during pregnancy: follow-up of a multicentre randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Karen Alterhaug Bjøntegaard ◽  
Signe Nilssen Stafne ◽  
Siv Mørkved ◽  
Kjell Åsmund Salvesen ◽  
Kari Anne I. Evensen
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
University Hospital ◽  
Moderate Intensity ◽  
Control Group ◽  
Exercise Protocol ◽  
Moderate Intensity Exercise ◽  
Randomised Controlled ◽  
Exercise During Pregnancy

Abstract Background There are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children’s body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children’s and mothers’ BMI and PA. Methods This was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007–2009 and 2014–2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child’s height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA. Results A total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children’s iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children’s BMI, weekly leisure time MVPA and intensity of PA correlated with mothers’ BMI, daily exercise, and intensity of exercise. Conclusions Regular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation. Trial registration The initial RCT study was registered in ClinicalTrials.govNCT00476567.

scholarly journals Lack of effects of evidence-based, individualised counselling on medication use in insured patients with mild hypertension in China: a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 102-108
Author(s):  
Mengyang Di ◽  
Chen Mao ◽  
Zuyao Yang ◽  
Hong Ding ◽  
Qu Liu ◽  
...  
Keyword(s):  
Mild Hypertension ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Medication Use ◽  
Control Group ◽  
Evidence Based ◽  
Randomised Controlled ◽  
Insured Patients

ObjectiveTo evaluate whether evidence-based, individualised (EBI) counselling regarding hypertension and the treatment would affect medication use in insured patients with mild hypertension in China.MethodsWe conducted a parallel-group, randomised controlled trial in two primary care centres in Shenzhen, a metropolitan city in China. Patients with mild primary hypertension, 10-year risk of cardiovascular diseases (CVDs) lower than 20% and no history of CVDs were recruited and randomly allocated to two groups. EBI plus general counselling was provided to the intervention group and general counselling alone to the control group. EBI counselling included information on the 10-year CVD risk and treatment benefit in terms of absolute risk reduction estimated for each individual and information on average side effects and costs of antihypertensive drugs. The outcomes included use of antihypertensive drugs and adherence to the treatment at 6-month follow-up, with the former being primary outcome.ResultsTwo hundred and ten patients were recruited, with 103 and 107 allocated to the intervention and control groups, respectively. At baseline, 62.4% of the patients were taking antihypertensive drugs that were all covered by health insurance. At the end of 6-month follow-up, there was no statistically significant difference in the rate of medication use between the intervention group and the control group (65.0% vs 57.9%; OR=1.35, 95% CI: 0.77 to 2.36). The difference in adherence rate between the two groups was not statistically significant either (43.7% vs 40.2%; OR=1.15, 95% CI 0.67 to 2.00]). The results were robust in sensitivity analyses that used different cutoffs to define the two outcomes.ConclusionsThe EBI counselling by health educators other than the caring physicians had little impact on treatment choices and drug-taking behaviours in insured patients with mild primary hypertension in this study. It remains unclear whether EBI counselling would make a difference in uninsured patients, especially when conducted by the caring physicians.Trial registration numberChiCTR-TRC-14004169.

A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Fatma Jendoubi ◽  
Stefana Balica ◽  
Marie Aleth Richard ◽  
Christine Chiaverini ◽  
Claire Bernier ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Intervention Group ◽  
Education Programme ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Randomised Controlled ◽  
To Receive

<b><i>Background:</i></b> Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. <b><i>Objective:</i></b> This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. <b><i>Methods:</i></b> Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. <b><i>Results:</i></b> A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; <i>p</i> &#x3c; 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. <b><i>Conclusions:</i></b> The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

scholarly journals A Long-Term Follow-Up Programme for Maintenance of Motor Function after Stroke: Protocol of the life after Stroke—The LAST Study

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Torunn Askim ◽  
Birgitta Langhammer ◽  
Hege Ihle-Hansen ◽  
Jon Magnussen ◽  
Torgeir Engstad ◽  
...  
Keyword(s):  
Motor Function ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Long Term Follow Up ◽  
Randomised Controlled

Background. There are no evidence-based strategies that have been shown to be superior in maintaining motor function for months to years after the stroke. The LAST study therefore intends to assess the effect of a long-term follow-up program for stroke patients compared to standard care on function, disability and health.Design. This is a prospective, multi-site randomised controlled trial, with blinded assessment 18 months after inclusion. A total of 390 patients will be recruited and randomised to a control group, receiving usual care, or to an intervention group 10 to 16 weeks after onset of stroke. Patients will be stratified according to stroke severity, age above 80, and recruitment site. The intervention group will receive monthly coaching on physical activity by a physiotherapist for 18 consecutive months after inclusion.Outcomes. The primary outcome is motor function (Motor Assessment Scale) 18 months after inclusion. Secondary outcomes are: dependency, balance, endurance, health-related quality of life, fatigue, anxiety and depression, cognitive function, burden on caregivers, and health costs. Adverse events and compliance to the intervention will be registered consecutively during follow-up.

scholarly journals Gender-informed psycho-educational programme to promote respectful relationships and reduce postpartum common mental disorders among primiparous women: long-term follow-up of participants in a community-based cluster randomised controlled trial

2018 ◽  
Vol 5 ◽  
Author(s):  
Jane Fisher ◽  
Thach Tran ◽  
Karen Wynter ◽  
Harriet Hiscock ◽  
Jordana Bayer ◽  
...  
Keyword(s):  
Mental Disorders ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Print Materials ◽  
Randomised Controlled ◽  
Primiparous Women ◽  
Trained Nurse

BackgroundWhat Were We Thinking (WWWT) is a gender-informed, psychoeducational programme to promote respectful relationships and skilled management of unsettled infant behaviours and thereby reduce postpartum common mental disorders. It comprises a highly structured seminar for couples and babies, usual primary care from a WWWT-trained nurse and take-home print materials. The aim was to assess long-term outcomes after a cluster randomised controlled trial of WWWT.MethodTrial participants who consented completed a computer-assisted telephone interview 18 months postpartum. Depressive symptoms were assessed with the Patient Health Questionnaire (PHQ-9) and anxiety symptoms with the Generalised Anxiety Disorder Scale (GAD-7). Impacts of baseline characteristics and trial arm on changes in scores from baseline to follow-up were calculated using Conditional Latent Growth Curve Models adjusting for prognostic indicators and controlling for clustering effects.ResultsOverall, 314/400 (78.5%) women contributed data at baseline (6 weeks postpartum), trial endline (26 weeks postpartum) and follow-up (12 months after trial endline). In intention-to-treat analyses, there was a significantly greater improvement in adjusted GAD-7 scores [regression coefficient (RC) −0.55; 95% confidence interval (CI) −0.94 to −0.17] and non-significant improvement (RC −0.27; 95% CI −0.63 to 0.08) in PHQ-9 scores from baseline to follow-up in the intervention than the control arm. In a per-protocol analysis, the proportion with GAD-7 scores ⩽4 (asymptomatic) improved 24.1% (55.7% baseline to 79.8% follow-up,p= 0.043) among women who received the full WWWT programme, which included the seminar, compared with 2.4% (77.1–79.5%,p= 0.706) among those who received the partial intervention (usual care from WWWT-trained nurse and print materials).ConclusionsThe WWWT programme has a significant sustained beneficial impact on postnatal generalised anxiety among primiparous women compared with usual care. The in-person seminar is the most influential component of the intervention. Psycho-educational programmes integrated into primary care appear promising as a strategy to reduce postpartum common mental disorders.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

The effect on length of sickness absence by recognition of undetected psychiatric disorder in long-term sickness absence. A randomized controlled trial

2009 ◽  
Vol 37 (8) ◽  
pp. 864-871 ◽  
Author(s):  
Hans Jørgen Søgaard ◽  
Per Bech
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Return To Work ◽  
Sickness Absence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Rate Of Return ◽  
Control Group ◽  
Randomized Controlled

Background: The burden caused by psychiatric disorders on the individual and society has resulted in more studies examining interventions aimed at reducing sickness absence. Aims: To examine if detection of undetected psychiatric disorders in long-term sickness absence (LSA) would improve the rate of return to work. Methods: Over one year all 2,414 incident persons on LSA in a well-defined population were within one week after eight weeks of continuous sickness absence posted the Common Mental Disorders Screening Questionnaire (CMD-SQ) to screen for mental disorders. In a randomized controlled trial (RCT), of 1,121 responding participants, persons with a minimum level of psychiatric symptoms 420 were allocated to the intervention group and 416 to the control group. The intervention was a psychiatric examination including diagnostics with Present State Examination and feedback regarding treatment and rehabilitation to the participants themselves, general practitioners and the social service taking care of the participants’ rehabilitation back to work. Of the 420 in the intervention group 329 (78.3%) participated in the intervention. The outcomes measure was in an intention treat analysis the rate of return to work. Results: The rate of return to work was non-significantly lower for the intervention group than for the control group, except for persons without a psychiatric sick-leave diagnosis who were sick-listed from full time work, who showed a significantly higher rate of return to work in the intervention group. Conclusions: The effect of interventions for return to work depends on socio-demographic characteristics. Further studies are needed regarding interventions to improve return to work.

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