An observational study in Adjustment Disorder With Work Inhibition, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Odense University Hospital · Observational
INTRODUCTION: Stress is one of the greatest burdens of our society and often imply impairments in cognitive and emotional functions. The investigators hypothesize that changes in the brain's dopamine(DA)-based mesocorticolimbic projections in patients with work-related stress (adjustment disorder) will manifest in altered glucose metabolism in relation to neural activity and altered DA radiotracer binding potential at neurotransmitter and receptor level.
MATERIAL AND METHODS: Subjects and healthy controls undergo neuropsychiatric tests and PET/MR imaging with three tracers: [18F]FDG to measure glucose metabolism as a marker of neural activity, [11C]raclopride to investigate the DA binding potential in the striatum, and [11C]FLB 457 to study possible impaired mesocortical dopaminergic transmission. To demonstrate difference in glucose metabolism ≥2x41 patients/controls are needed.
OUTCOME: The investigators expect to find that symptoms of cognitive and motivational/reward deficits could be attributable to changes in frontal lobe and striatal glucose metabolism in >50% of patients and that changes in striatal D2 receptors and impaired mesocortical dopaminergic transmission in the prefrontal cortex are contributing factors.
CONCLUSION: This project aims to generate entirely new and objective evidence of stress-induced cerebral illness and provide a basis for in depth research and more rational management of this strenuous disorder.
Recruitment procedure: The department of Occupational and Environmental Medicine (DOE) at OUH have developed a screening procedure to recruit patients diagnosed according to the ICD10 F43.2x, and exposed to predominant psychosocial work stressors. The patients are recruited among women and men aged 18-64. At the DOE subjects undergo a clinical diagnostic interview based on the ICD 10 criteria including screening for stressors in the psychosocial work environment and their relationship to disease development, private life strains, personal back-ground, mental vulnerability, and competing somatic disease, as well as tests for depression and anxiety symptoms, respectively the Beck Anxiety Inventory (BAI) and Major Depression Inventory (MDI). The psychosocial work environ-ment stressors being screened for are: quantitative demands, emotional demands, role conflict, role ambiguity, sup-port and encouragement, organizational justice, adequate education and training (skill level). The experience of stressors is assessed in relation to the most dominant stress models, "demand-control-support" (Karasek), "effort and reward imbalance at work" (Siegrist), "Stress as Offense two self" (Semmer), and classical stress theory focusing on appraisal / coping (Lazarus or Ursin).
The procedure is onward going to be performed automatically in an online environment. Due to the nature of neurobiology the scans must be conducted within a fairly short time period after the initial diagnosis. Hence a declaration of consent will be presented and signed at the day of the first scan, also ensuring that all additional questions can be answered by the main investigator. The scans will be conducted within a fortnight after the fists contact. In connection with the scans, the main investigator will conduct an SCAN-PSE interview for the assessment of mental symptoms to determine if the participant's condition has changed since they decided to participate in the trial. Healthy controls are recruited and matched with regard to gender, age, educational and occupational background. Further, controls are screened for confounding factors in a similar manner as the patient group.
237 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.
This study's planned enrollment of 82 is below the median of 200 across 62 observational studies indexed under Occupational Stress.
Browse Occupational Stress studies →Odense University Hospital is the lead sponsor of 480 studies on the registry; 111 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients are recruited among women aged 18-64 years.
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Population and controls:
Study population:
Exclusion criteria.
Population, patients and controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with work-related Adjustment disorder
Radiation: PET/MR scans
Healthy controls
Radiation: PET/MR scans
Observations of glucose metabolism and dopamine binding potential
Glucose metabolism
PET/MR scan
Time frame: 3 year
Dopamine binding potential
PET/MR scan
Time frame: 3-4 years
Plan to share: No
Started May 2018 (actual). Primary completion is estimated for Mar 2023, 58 months after the start.
Of 27 observational studies under Occupational Stress, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 41. This study's planned 58 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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