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Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature299363
Source
Trials. 2018 Mar 27; 19(1):203
Publication Type
Clinical Trial Protocol
Journal Article
Date
Mar-27-2018
Author
Tom Østergaard
Tobias Lundgren
Robert Zettle
Rune Jonassen
Catherine J Harmer
Tore C Stiles
Nils Inge Landrø
Vegard Øksendal Haaland
Author Affiliation
Department of Psychiatry, Sørlandet Hospital, Arendal, Norway. tom.ostergaard@sshf.no.
Source
Trials. 2018 Mar 27; 19(1):203
Date
Mar-27-2018
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Acceptance and Commitment Therapy
Adolescent
Adult
Aged
Attentional Bias
Depression - diagnosis - psychology - therapy
Female
Humans
Male
Middle Aged
Multicenter Studies as Topic
Norway
Psychotherapy, Group
Randomized Controlled Trials as Topic
Recurrence
Remission Induction
Time Factors
Treatment Outcome
Young Adult
Abstract
This project studies the effect of group-based Acceptance and Commitment Therapy (ACT) following Attention Bias Modification (ABM) on residual symptoms in recurrent depression. ACT is a cognitive-behavioral intervention combining acceptance and mindfulness processes with commitment and behavior-change processes. ACT enjoys modest empirical support in treating depression and has also shown promising results in secondary prevention of depression. The experimental cognitive bias modification (ABM) procedure has been shown to reduce surrogate markers of depression vulnerability in patients in remission from depression. The aim of the current project is to investigate if the effect of group-based ACT on reducing residual depressive symptoms can be enhanced by preceding it with ABM. Also, assessment of the relationship between conceptually relevant therapeutic processes and outcome will be investigated.
An invitation to participate in this project was extended to 120 individuals within a larger sample who had just completed a separate randomized, multisite, clinical trial (referred to hereafter as Phase 1) in which they received either ABM (n = 60) or a control condition without bias modification (n = 60). This larger Phase-1 sample consisted of 220 persons with a history of at least two episodes of major depression who were currently in remission or not fulfilling the criteria of major depression. After its inclusion, Phase-1 participants from the Sørlandet site (n = 120) were also recruited for this study in which they received an 8-week group-based ACT intervention. Measures will be taken immediately after Phase 1, 1 month, 2 months, 6 months, and 1 year after the conclusion of Phase 1.
This study sequentially combines acceptable, nondrug interventions from neuropsychology and cognitive-behavioral psychology in treating residual symptoms in depression. The results will provide information about the effectiveness of treatment and on mechanisms and processes of change that may be valuable in understanding and further developing ABM and ACT, combined and alone.
ClinicalTrials.gov, Identifier: NCT02648165 . Registered on 6 January 2016.
PubMed ID
29587807 View in PubMed
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Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature299593
Source
BMC Musculoskelet Disord. 2019 Jan 05; 20(1):7
Publication Type
Clinical Trial Protocol
Journal Article
Date
Jan-05-2019
Author
Ivar Magne Austevoll
Erland Hermansen
Morten Fagerland
Frode Rekeland
Tore Solberg
Kjersti Storheim
Jens Ivar Brox
Greger Lønne
Kari Indrekvam
Jørn Aaen
Oliver Grundnes
Christian Hellum
Author Affiliation
Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Hagavik, N- 5217, Bergen, Norway. imau@helse-bergen.no.
Source
BMC Musculoskelet Disord. 2019 Jan 05; 20(1):7
Date
Jan-05-2019
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Decompression, Surgical - adverse effects
Disability Evaluation
Equivalence Trials as Topic
Humans
Multicenter Studies as Topic
Norway
Pain Measurement
Recovery of Function
Spinal Fusion - adverse effects - instrumentation
Spinal Stenosis - diagnosis - physiopathology - surgery
Spondylolisthesis - diagnosis - physiopathology - surgery
Time Factors
Treatment Outcome
Abstract
Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study.
The NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion. Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10?years.
The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group.
ClinicalTrials.gov Identifier: NCT02051374 . First Posted: January 31, 2014. Last Update Posted: February 14, 2018.
PubMed ID
30611229 View in PubMed
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Digitally supported program for type 2 diabetes risk identification and risk reduction in real-world setting: protocol for the StopDia model and randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature299265
Source
BMC Public Health. 2019 Mar 01; 19(1):255
Publication Type
Clinical Trial Protocol
Journal Article
Date
Mar-01-2019
Author
Jussi Pihlajamäki
Reija Männikkö
Tanja Tilles-Tirkkonen
Leila Karhunen
Marjukka Kolehmainen
Ursula Schwab
Niina Lintu
Jussi Paananen
Riia Järvenpää
Marja Harjumaa
Janne Martikainen
Johanna Kohl
Kaisa Poutanen
Miikka Ermes
Pilvikki Absetz
Jaana Lindström
Timo A Lakka
Author Affiliation
Department of Clinical Nutrition, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70210, Kuopio, Finland. jussi.pihlajamaki@uef.fi.
Source
BMC Public Health. 2019 Mar 01; 19(1):255
Date
Mar-01-2019
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Adolescent
Adult
Aged
Cost-Benefit Analysis
Diabetes Mellitus, Type 2 - economics - etiology - prevention & control
Female
Finland
Health Promotion - economics - methods
Healthy Lifestyle
Humans
Male
Mass Screening - economics - methods
Middle Aged
Primary Health Care - economics - methods
Randomized Controlled Trials as Topic
Risk Assessment - economics - methods
Risk Reduction Behavior
Surveys and Questionnaires
Young Adult
Abstract
The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT.
The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70?years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC =12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system.
Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care.
ClinicalTials.gov . Identifier: NCT03156478 . Date of registration 17.5.2017.
PubMed ID
30823909 View in PubMed
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Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

https://arctichealth.org/en/permalink/ahliterature300392
Source
Trials. 2018 Jan 08; 19(1):14
Publication Type
Clinical Trial Protocol
Journal Article
Date
Jan-08-2018
Author
Erik Lundström
Eva Isaksson
Per Wester
Ann-Charlotte Laska
Per Näsman
Author Affiliation
Karolinska Institutet, Department of Clinical Neuroscience, Neurology, Karolinska University Hospital, Solna, 171 76, Stockholm, Sweden. erik.lundstrom@gmail.com.
Source
Trials. 2018 Jan 08; 19(1):14
Date
Jan-08-2018
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Contracts
Fluoxetine - administration & dosage - adverse effects
Humans
Multicenter Studies as Topic
Patient Selection
Pragmatic Clinical Trials as Topic
Recovery of Function
Research Personnel - psychology
Sample Size
Serotonin Uptake Inhibitors - administration & dosage - adverse effects
Stroke - diagnosis - physiopathology - therapy
Stroke Rehabilitation - adverse effects - methods
Sweden
Telecommunications
Time Factors
Treatment Outcome
Abstract
Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT.
ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n?=?27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT.
EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the future. It might also be useful in clinical settings outside the field of stroke.
The ERUTECC study was registered in the Northern Ireland Hub for Trials Methodology Research Studies Within a Trial repository ( SWAT58 ) on 30 April 2017. ClinicalTrials.gov, ID: NCT02683213 . Retrospectively registered on 2 February 2016.
PubMed ID
29310679 View in PubMed
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Evaluating Modular Approach to Therapy for Children with Anxiety, Depression, Trauma and Conduct Problems (MATCH-ADCT) in Norwegian child and adolescent outpatient clinics: Study protocol for a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature300299
Source
Trials. 2019 Jan 07; 20(1):16
Publication Type
Clinical Trial Protocol
Journal Article
Date
Jan-07-2019
Author
Kristine Amlund Hagen
Asgeir Røyrhus Olseth
Hanne Laland
Kristian Rognstad
Anett Apeland
Elisabeth Askeland
Knut Taraldsen
Bernadette Christensen
John Kjøbli
Ana M Ugueto
Sarah Kate Bearman
John Weisz
Author Affiliation
The Norwegian Center for Child Behavioral Development (NCCBD), a University of Oslo affiliate, Postboks 7053, Majorstuen, 0306, Oslo, Norway. k.a.hagen@nubu.no.
Source
Trials. 2019 Jan 07; 20(1):16
Date
Jan-07-2019
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Adolescent
Anxiety - therapy
Child
Child Behavior Disorders - therapy
Depression - therapy
Female
Humans
Male
Norway
Outpatients
Quality Assurance, Health Care
Randomized Controlled Trials as Topic
Research Design
Wounds and Injuries - therapy
Abstract
Norwegian health, care, and welfare services are experiencing increased demands to deliver services that are safe, effective, of high quality, and that ensure user involvement. Yet, evidence-based treatment for common disorders such as depression, anxiety, trauma, and behavioral problems in children are not regularly used in clinical practice in Norway. Possible explanations for this are that many standard, evidence-based treatments may have difficulty addressing the complexity and comorbidity of referred children and the fact that children's treatment needs often shift during treatment. The Modular Approach to Therapy for children with Anxiety, Depression, Trauma and Conduct problems (MATCH-ADTC) was designed to address these challenges and reduce some of the barriers to therapists' use of evidence-based treatment in their practice.
Participants will include 280 children (aged 6-14.5?years at intake) who receive treatment in child and adolescent mental health outpatient clinics in Norway, and their families. Families are randomly assigned to either the experimental group receiving treatment from therapists trained in MATCH, or to the comparison group receiving treatment from therapists delivering treatment as usual (TAU). Data on children's symptomology, child and family functioning, demographics, background information, and mental health outcomes are collected as well as frequent feedback on treatment response, plus video-recordings of treatment sessions and implementation quality scores from each participating clinic. Questionnaires are administered in six waves.
MATCH has been tested in the US with promising results, but we do not know whether this treatment approach will produce similar results in Norway. The implications of this study are 1. Possibly better treatment outcomes and/or more efficient improvements for children and families treated in mental health outpatient clinics in Norway 2. Clinicians learning to use more evidence-based practices in their treatment 3. Implementation of standard procedures for obtaining feedback from children and families and sharing the feedback with clinicians 4. Increased understanding, at the end of the trial, of whether introducing MATCH improves outcomes for children and families treated in mental health outpatient clinics TRIAL REGISTRATION: ISRCTN, registration number: ISRCTN24029895 . Registered on 8 August 2016.
PubMed ID
30616662 View in PubMed
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The Food4toddlers study - study protocol for a web-based intervention to promote healthy diets for toddlers: a randomized controlled trial.

https://arctichealth.org/en/permalink/ahliterature302116
Source
BMC Public Health. 2019 May 14; 19(1):563
Publication Type
Clinical Trial Protocol
Journal Article
Date
May-14-2019
Author
Margrethe Røed
Elisabet R Hillesund
Frøydis N Vik
Wendy Van Lippevelde
Nina Cecilie Øverby
Author Affiliation
Department of Public Health, Sport and Nutrition, Faculty of Health and Sport Sciences, University of Agder, PO box 422, 4604, Kristiansand, Norway. margrethe.roed@uia.no.
Source
BMC Public Health. 2019 May 14; 19(1):563
Date
May-14-2019
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Keywords
Child, Preschool
Feeding Behavior - psychology
Female
Health Promotion - methods
Healthy Diet - methods - psychology
Humans
Infant
Internet
Male
Mobile Applications
Norway
Parents - psychology
Pediatric Obesity - prevention & control
Program Evaluation
Randomized Controlled Trials as Topic
Retrospective Studies
Telemedicine - methods
Abstract
Eating habits are established during childhood and track into adolescence and later in life. Given that these habits have a large public health impact and influence the increasing rates of childhood obesity worldwide, there is a need for effective, evidence-based prevention trials promoting healthy eating habits in the first 2?years of life. The aim of this study was to develop and evaluate the effect of an eHealth intervention called Food4toddlers, aiming to promote healthy dietary habits in toddlers by targeting parents' awareness of their child's food environment (i.e., how food is provided or presented) and eating environment (e.g., feeding practices and social interaction). This paper describes the rationale, development, and evaluation design of this project.
We developed a 6-month eHealth intervention, with the extensive user involvement of health care nurses and parents of toddlers. This intervention is in line with the social cognitive theory, targeting the interwoven relationship between the person, behavior, and environment, with an emphasis on environmental factors. The intervention website includes recipes, information, activities, and collaboration opportunities. The Food4toddlers website can be used as a mobile application. To evaluate the intervention, a two-armed pre-post-follow-up randomized controlled trial is presently being conducted in Norway. Parents of toddlers (n =?404) were recruited via social media (Facebook) and 298 provided baseline data of their toddlers at age 12?months. After baseline measurements, participants were randomly allocated to an intervention group or control group. Primary outcomes are the child's diet quality and food variety. All participants will be followed up at age 18?months, 2?years, and 4?years.
The results of this trial will provide evidence to increase knowledge about the effectiveness of an eHealth intervention targeting parents and their toddler's dietary habits.
ISRCTN92980420 . Registered 13 September 2017. Retrospectively registered.
PubMed ID
31088438 View in PubMed
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How does exercise dose affect patients with long-term osteoarthritis of the knee? A study protocol of a randomised controlled trial in Sweden and Norway: the SWENOR Study.

https://arctichealth.org/en/permalink/ahliterature299644
Source
BMJ Open. 2018 05 05; 8(5):e018471
Publication Type
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Date
05-05-2018
Author
Tom Arild Torstensen
Wilhelmus J A Grooten
Håvard Østerås
Annette Heijne
Karin Harms-Ringdahl
Björn Olov Äng
Author Affiliation
Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden.
Source
BMJ Open. 2018 05 05; 8(5):e018471
Date
05-05-2018
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Keywords
Aged
Aged, 80 and over
Exercise Therapy - methods
Female
Humans
Knee Joint - physiopathology
Logistic Models
Male
Middle Aged
Multicenter Studies as Topic
Multivariate Analysis
Norway
Osteoarthritis, Knee - rehabilitation
Pain - etiology
Pain Measurement - methods
Prospective Studies
Randomized Controlled Trials as Topic
Sweden
Treatment Outcome
Abstract
Osteoarthritis (OA) of the knee is characterised by knee pain, disability and degenerative changes, and places a burden on societies all over the world. Exercise therapy is an often-used modality, but there is little evidence of what type of exercise dose is the most effective, indicating a need for controlled studies of the effect of different dosages. Thus, the aim of the study described in this protocol is to evaluate the effects of high-dose versus low-dose medical exercise therapy (MET) in patients with knee OA.
This is a multicentre prospective randomised two-arm trial with blinded assessment and data analysis. We are planning to include 200 patients aged 45-85 years with symptomatic (pain and decreased functioning) and X-ray verified diagnosis of knee OA. Those eligible for participation will be randomly allocated to either high-dose (n=100) or low-dose (n=100) MET. All patients receive three supervised treatments each week for 12 weeks, giving a total of 36 MET sessions. The high-dose group exercises for 70-90?min compared with 20-30?min for the low-dose group. The high-dose group exercises for a longer time, and receives a greater number of exercises with more repetitions and sets. Background and outcome variables are recorded at inclusion, and outcome measures are collected after every sixth treatment, at the end of treatment, and at 6-month and 12-month follow-ups. Primary outcome is self-rated knee functioning and pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The primary end point is at the end of treatment after 3?months, and secondary end points are at 6 months and 12 months after the end of treatment.
This project has been approved by the Regional Research Ethics Committees in Stockholm, Sweden, and in Norway. Our results will be submitted to peer-reviewed journals and presented at national and international conferences.
NCT02024126; Pre-results.
PubMed ID
29730615 View in PubMed
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Impact of body weight, low energy diet and gastric bypass on drug bioavailability, cardiovascular risk factors and metabolic biomarkers: protocol for an open, non-randomised, three-armed single centre study (COCKTAIL).

https://arctichealth.org/en/permalink/ahliterature300198
Source
BMJ Open. 2018 05 29; 8(5):e021878
Publication Type
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Date
05-29-2018
Author
Jøran Hjelmesæth
Anders Åsberg
Shalini Andersson
Rune Sandbu
Ida Robertsen
Line Kristin Johnson
Philip Carlo Angeles
Jens Kristoffer Hertel
Eva Skovlund
Maria Heijer
Anna-Lena Ek
Veronica Krogstad
Tor-Ivar Karlsen
Hege Christensen
Tommy B Andersson
Cecilia Karlsson
Author Affiliation
The Morbid Obesity Center, Vestfold Hospital Trust, Tønsberg, Norway.
Source
BMJ Open. 2018 05 29; 8(5):e021878
Date
05-29-2018
Language
English
Publication Type
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Keywords
Biological Availability
Biomarkers
Body Composition
Caloric Restriction - adverse effects
Cardiovascular Diseases - etiology
Clinical Trials as Topic
Female
Gastric Bypass - adverse effects - methods
Humans
Linear Models
Male
Norway
Obesity, Morbid - therapy
Pharmaceutical Preparations
Pharmacokinetics
Risk factors
Tertiary Care Centers
Weight Loss
Abstract
Roux-en-Y gastric bypass (GBP) is associated with changes in cardiometabolic risk factors and bioavailability of drugs, but whether these changes are induced by calorie restriction, the weight loss or surgery per se, remains uncertain. The COCKTAIL study was designed to disentangle the short-term (6?weeks) metabolic and pharmacokinetic effects of GBP and a very low energy diet (VLED) by inducing a similar weight loss in the two groups.
This open, non-randomised, three-armed, single-centre study is performed at a tertiary care centre in Norway. It aims to compare the short-term (6?weeks) and long-term (2?years) effects of GBP and VLED on, first, bioavailability and pharmacokinetics (24?hours) of probe drugs and biomarkers and, second, their effects on metabolism, cardiometabolic risk factors and biomarkers. The primary outcomes will be measured as changes in: (1) all six probe drugs by absolute bioavailability area under the curve (AUCoral/AUCiv) of midazolam (CYP3A4 probe), systemic exposure (AUCoral) of digoxin and rosuvastatin and drug:metabolite ratios for omeprazole, losartan and caffeine, levels of endogenous CYP3A biomarkers and genotypic variation, changes in the expression and activity data of the drug-metabolising, drug transport and drug regulatory proteins in biopsies from various organs and (2) body composition, cardiometabolic risk factors and metabolic biomarkers.
The COCKTAIL protocol was reviewed and approved by the Regional Committee for Medical and Health Research Ethics (Ref: 2013/2379/REK sørøst A). The results will be disseminated to academic and health professional audiences and the public via presentations at conferences, publications in peer-reviewed journals and press releases and provided to all participants.
NCT02386917.
PubMed ID
29844102 View in PubMed
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Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA).

https://arctichealth.org/en/permalink/ahliterature303005
Source
BMC Public Health. 2018 07 18; 18(1):889
Publication Type
Clinical Trial Protocol
Comparative Study
Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
07-18-2018
Author
Elisabeth Björk Brämberg
Kristina Holmgren
Ute Bültmann
Hanna Gyllensten
Jan Hagberg
Lars Sandman
Gunnar Bergström
Author Affiliation
Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, 171 77, Stockholm, Sweden. elisabeth.bjork.bramberg@ki.se.
Source
BMC Public Health. 2018 07 18; 18(1):889
Date
07-18-2018
Language
English
Publication Type
Clinical Trial Protocol
Comparative Study
Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Keywords
Adolescent
Adult
Cost-Benefit Analysis
Employment
Female
Health status
Humans
Male
Mental Disorders - rehabilitation - therapy
Middle Aged
Primary Health Care
Problem Solving
Quality of Life
Research Design
Return to Work - statistics & numerical data
Sick Leave - economics - statistics & numerical data
Sweden
Young Adult
Abstract
Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders.
The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity.
The study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care.
ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.
PubMed ID
30021545 View in PubMed
Less detail

Increasing return-to-work among people on sick leave due to common mental disorders: design of a cluster-randomized controlled trial of a problem-solving intervention versus care-as-usual conducted in the Swedish primary health care system (PROSA).

https://arctichealth.org/en/permalink/ahliterature303185
Source
BMC Public Health. 2018 07 18; 18(1):889
Publication Type
Clinical Trial Protocol
Comparative Study
Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
07-18-2018
Author
Elisabeth Björk Brämberg
Kristina Holmgren
Ute Bültmann
Hanna Gyllensten
Jan Hagberg
Lars Sandman
Gunnar Bergström
Author Affiliation
Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, 171 77, Stockholm, Sweden. elisabeth.bjork.bramberg@ki.se.
Source
BMC Public Health. 2018 07 18; 18(1):889
Date
07-18-2018
Language
English
Publication Type
Clinical Trial Protocol
Comparative Study
Journal Article
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Keywords
Adolescent
Adult
Cost-Benefit Analysis
Employment
Female
Health status
Humans
Male
Mental Disorders - rehabilitation - therapy
Middle Aged
Primary Health Care
Problem Solving
Quality of Life
Research Design
Return to Work - statistics & numerical data
Sick Leave - economics - statistics & numerical data
Sweden
Young Adult
Abstract
Common mental disorders affect about one-third of the European working-age population and are one of the leading causes of sick leave in Sweden and other OECD countries. Besides the individual suffering, the costs for society are high. This paper describes the design of a study to evaluate a work-related, problem-solving intervention provided at primary health care centers for employees on sick leave due to common mental disorders.
The study has a two-armed cluster randomized design in which the participating rehabilitation coordinators are randomized into delivering the intervention or providing care-as-usual. Employees on sick leave due to common mental disorders will be recruited by an independent research assistant. The intervention aims to improve the employee's return-to-work process by identifying problems perceived as hindering return-to-work and finding solutions. The rehabilitation coordinator facilitates a participatory approach, in which the employee and the employer together identify obstacles and solutions in relation to the work situation. The primary outcome is total number of sick leave days during the 18-month follow-up after inclusion. A long-term follow-up at 36 months is planned. Secondary outcomes are short-term sick leave (min. 2 weeks and max. 12 weeks), psychological symptoms, work ability, presenteeism and health related quality of life assessed at baseline, 6 and 12-month follow-up. Intervention fidelity, reach, dose delivered and dose received will be examined in a process evaluation. An economic evaluation will put health-related quality of life and sick leave in relation to costs from the perspectives of society and health care services. A parallel ethical evaluation will focus on the interventions consequences for patient autonomy, privacy, equality, fairness and professional ethos and integrity.
The study is a pragmatic trial which will include analyses of the intervention's effectiveness, and a process evaluation in primary health care settings. Methodological strengths and challenges are discussed, such as the risk of selection bias, contamination and detection bias. If the intervention shows promising results for return-to-work, the prospects are good for implementing the intervention in routine primary health care.
ClinicalTrials.gov Identifier: NCT03346395 Registered January, 12 2018.
PubMed ID
30021545 View in PubMed
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