- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185727
Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
Training Intervention in the Treatment of Anorexia Nervosa (STRONG_2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eating disorders (EDs) are the most common psychiatric disorder affecting young women and contribute with serious psychological, social, physical health complications, and a high mortality rate.
The first general treatment goal of EDs is to address medical complications and suicide risk, and then pathological health effects of the EDs such as bingeing and vomiting. Thereafter, the aim is to address ED psychopathology and behaviors via different forms of psychotherapy. Medical treatment is also used to treat comorbidities.
Treatment of EDs using standard of care (SOC) often implies a reduction in physical activity, and exercise is often prohibited during the intense phase of weight restoration. Since many patients for lengthy periods of time use excessive exercise as a way of compensatory behavior for calorie intake, the sudden stop in physical activity may trigger anxiety and lack of compliance during the weight restoration program. In addition, many ED patients have osteopenia, reduced muscle mass and show signed of depressiveness, all of which benefits from physical activity.
In order to change unhealthy exercise in patients with eating disorders, it may be beneficial to experience exercise in a novel way as part of the treatment for EDs. The number of studies describing supervised exercise for patients with EDs are few, especially for studies examining the effects of implementing exercise in the treatment of EDs in a Danish context. The National Clinical Guidelines suggest that supervised physical activity should be considered in the weight gaining phase as a supplement for common treatment for patients with anorexia nervosa (AN), although there is no description of how this intervention should be implemented (Sundhedsstyrelsen 2005). Knowledge concerning patients' pathological use of training and how this could be managed during rehabilitation is inadequate.
The STRONG_2 project will compare the effects of supervised strength training as add on to standard of care (SOC) vs. SOC alone, in patients with EDs at the Mental Health Center Ballerup (PCB) in the Capital Region of Denmark. Training effects on health parameters including muscle strength, eating disorder psychopathology and pathological exercise will be explored.
The STRONG_2 study will enable an increased understanding of the effects of supervised strength training on muscle strength, increase in muscle mass, and improved bone health, metabolism as well as ED psychopathology.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2200 and 1958
- Institut for Idræt og Ernæring, NEXS, University of Copenhagen
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Danmark
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Ballerup, Danmark, Denmark, 2750
- Eating disorder unit, Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with AN according to the International Classification of Disorders version 10 (ICD-10)
- Age 18-35
- BMI > 14.5
- Signed informed consent form-
Exclusion Criteria:
- Forced care
- Unstable medical or psychiatric health
- Issues with compliance to treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard of Care (SOC)
Therapy control group
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Experimental: Standard of Care (SOC) + strength training
Strength training intervention as add on to therapy
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12 weeks supervised strength training exposure.
The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks.
The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal strength leg press
Time Frame: Base line, week 6, week 12
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Difference in muscle strength measured with leg press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Strength test measurement tool is leg press measured with 1 repetition maximum (1RM) in Kilograms (kg).
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Base line, week 6, week 12
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Maximal strength bench press
Time Frame: Base line, week 6, week 12
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Difference in muscle strength measured with bench press strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Strength test measurement tool is bench press measured with 1 repetition maximum (1RM) in Kilograms (kg).
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Base line, week 6, week 12
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Maximal strength pull down
Time Frame: Base line, week 6, week 12
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Difference in muscle strength measured with pull down strength tests in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Strength test measurement tool is pull down measured with 1 repetition maximum (1RM) in Kilograms (kg).
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Base line, week 6, week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EDI-DT subscale score
Time Frame: Baseline, week 6, week 12, week 24
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Difference in drive for thinness measured with EDI questionnaire scores in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 1 to 6 where 6 means a better outcome.
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Baseline, week 6, week 12, week 24
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EDI subscale score
Time Frame: Baseline, week 6, week 12, week 24
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Difference in body dissatisfaction measured with EDI questionnaire scores in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 1 to 6 where 6 means a better outcome.
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Baseline, week 6, week 12, week 24
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Changes in Eating Disorder Symptoms
Time Frame: Baseline, week 12, week 24
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Difference in eating disorder symptoms measured with EDE-Q questionnaire in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 0 to 6 where 6 means a worse outcome.
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Baseline, week 12, week 24
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VAS-mood
Time Frame: Baseline, week 1, week 6, week 12, week 24
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Difference in mood measured with VAS-mood in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a Vas-scale from 0 to 10.
For anxiety 10 means a worse outcome, for behavior 10 means a worse outcome and for feelings 10 means a worse outcome and for a happiness question 10 means the best outcome.
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Baseline, week 1, week 6, week 12, week 24
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Anxiety (HAM-A-6)
Time Frame: Baseline, week 6, week 12, week 24
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Difference in anxiety measured with HAM-A-6 questionnaire in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 0 to 4 and higher total score means a worse outcome.
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Baseline, week 6, week 12, week 24
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ERQ total score
Time Frame: Baseline, week 6, week 12, week 24
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Difference in emotional reactivity measured with ERQ questionnaire total score in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 1 to 7. With respect to questions for Cognitive Reappraisal Facets a higher score means better outcome and for questions regarding Expressive Suppression Facets a higher score means a worse outcome.
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Baseline, week 6, week 12, week 24
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RMR assessed by indirect calorimetry (ventilated open hood) and RMRratio
Time Frame: Baseline, week 6, week 12
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Difference in resting metabolic rate measured with indirect calorimetry and RMRratio in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
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Baseline, week 6, week 12
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BMD assessed by Dual-energy X-ray Absorptiometry (DXA)
Time Frame: Baseline, week 12
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Difference in bone mineral density measured by Dual-energy X-ray Absorptiometry (DXA) (total bone mineral content, BMD lumbar spine and femur neck[g/m2]) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
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Baseline, week 12
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Anthropometry
Time Frame: Baseline, week 12
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Difference in anthropometry (bodyweight, fat mass, and fat free mass) measured with DXA in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
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Baseline, week 12
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Blood samples Lipid profiles
Time Frame: Baseline,week 12
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Difference in biological parameters measured by changes in lipid levels, like cholesterol, high-density lipoprotein, low-density lipoprotein, very-low-density lipoproteins, triglycerides, free fatty acids, apolipoprotein a1 and B in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Lipidomics, a mass spectrometry based systems level analysis of lipids will be applied for level analysis of lipids and their interacting partners.
High or low risk lipid-profiles will be analysed in the two patient groups with high risk lipid profiles expected to mean a worse outcome.
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Baseline,week 12
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Blood samples Hormones
Time Frame: Baseline,week 12
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Difference in biological parameters measured by changes in hormone levels, like insulin, prostaglandins, cortisol, follicle stimulating hormone, ghrelin, obestatin, resistin, des- acyl-ghrelin, acyl-ghrelin, growth hormone, oxytocin, T3, cortisol, IGF-1, prolactin, estrogen, 17-beta-estradiol, LH, adiponectin, leptin, agouti-related protein, cholecystokinin, alpha-MSH, as well as related variants in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. The project will examine whether higher levels or lower levels are correlated with a worse or better outcome in the two patient groups. |
Baseline,week 12
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Blood samples Neuronal biomarkers
Time Frame: Baseline,week 12
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Difference in biological parameters measured by changes in neuronal biomarker levels, like Glial cell line derived neurotrophic factor, Brain derived neurotrophic factor, Wnt- signaling pathway, nerve growth factor, insulin-like growth factor, S-110b, Neuron specific enolase, monoamines as well as related metabolites/variants, neuropeptide Y, HMGB1, as well as related isoforms in blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training. The project will examine whether higher levels or lower levels are correlated with a worse or better outcome in the two patient groups. |
Baseline,week 12
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Weekly binge eating
Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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Difference in weekly binge eating noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured as number of binge eating during the week.
A higher score means a worse outcome.
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Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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Vomiting
Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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Difference in weekly vomiting noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured as number of vomiting during the week.
A higher score means a worse outcome.
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Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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Weekly use of laxatives
Time Frame: Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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Difference in weekly use of laxatives noted every week of the study in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured as number of laxative use per week and the dose of the specific laxative used.
A higher score and dose per week means a worse outcome.
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Baseline, week 1,2,3,4,5,6,7,8,9,10,11,12 and week 24
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EAI score
Time Frame: Baseline, week 6, week 12, week 24
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Difference in exercise addiction measured with (Exercise Addiction Inventory) EAI score in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured on a scale from 1 to 5 where higher score means a worse outcome.
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Baseline, week 6, week 12, week 24
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EDS score
Time Frame: Baseline, week 6, week 12, week 24
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Difference in exercise addiction measured with Exercise Dependence Scale (EDS) score in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured on a scale from 1 to 6 where higher score means a worse outcome.
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Baseline, week 6, week 12, week 24
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Body Awareness test (BAT)
Time Frame: Baseline, week 1,2,6,7,12 and week 24
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Difference in body awareness measured with Body Awareness test (BAT) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Questions are scored on a scale ranging from never to always with four items in between.
Always means a worse outcome except for two questions regarding body satisfaction and relaxation where always means a better outcome.
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Baseline, week 1,2,6,7,12 and week 24
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Compulsive Exercise test
Time Frame: Baseline, week 1, 2, 6, 7, 12 and week 24
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Difference in compulsive exercise measured with Compulsive Exercise test (CET) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured on a scale from 0 to 5 where higher score means a worse outcome except for two questions where higher score means better outcome.
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Baseline, week 1, 2, 6, 7, 12 and week 24
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Activity and sleep tracking via Actigraph
Time Frame: Baseline, week 6, week 12, week 24
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Difference in activity/sleep measured with Actigraph in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
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Baseline, week 6, week 12, week 24
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Readiness and motivations interview
Time Frame: Baseline, week 1, week 6, week 7, week 12, week 24
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Difference in readiness/motivations measured with Readiness and motivations interview in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured on a scale from 1 to 10 where higher score means a better outcome.
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Baseline, week 1, week 6, week 7, week 12, week 24
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Patient satisfaction: Expectations and experiences of ED-treatment scale
Time Frame: Baseline, week 6, week 12, week 24
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Difference in patient satisfaction measured with the Expectations and experiences of ED-treatment scale (Clinton 2001) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 0 to 2 where higher score means worse outcome.
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Baseline, week 6, week 12, week 24
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Global Assessment of Functioning (GAF)
Time Frame: Baseline, week 6, week 12, week 24
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Difference in social functioning measured with numeric scale using the Global Assessment of Functioning (GAF-F and GAF-S) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is measured on a scale from 1 to 99 where lower score means a worse outcome.
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Baseline, week 6, week 12, week 24
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Clinical Global Impression (CGI)
Time Frame: Baseline, week 6, week 12, week 24
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Difference in severity of the patient's illness measured with 7-point scale using the Clinical Global Impression - Severity scale (CGI-S) in patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Scoring is on a scale from 1 to 7 where higher score means worse outcome.
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Baseline, week 6, week 12, week 24
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Bone turnover CTX-1
Time Frame: Baseline, week 12
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Difference in bone turnover measured with analyses of the bone marker CTX-1 from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
High levels above reference range which is 50 - 450 measured in pg/ml indicate worse outcome.
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Baseline, week 12
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Bone turnover PN1P
Time Frame: Baseline, week 12
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Difference in bone turnover measured with analyses of the bone formation marker PN1P from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
High levels above normal reference range which is 20 - 85 measured in microgram/L can indicate worse outcome.
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Baseline, week 12
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Bone turnover Osteocalcin
Time Frame: Baseline, week 12
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Difference in bone turnover measured with analyses of the bone marker Osteocalcin from blood material from patients treated with standard of care alone compared to patients treated with standard of care and strength training.
Increased levels above normal reference range which is 0.7 - 6.5 measured in ng/ml mean higher osteoblast activity and formation of new bone and mean better outcome for most patients.
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Baseline, week 12
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Collaborators and Investigators
Investigators
- Principal Investigator: Jan Magnus Sjögren, MD, PhD, Eating disorder unit, Mental Health Services in the Capital Region, Ballerup
- Study Chair: Louise B Rasmussen, MD, PhD, Mental Health Services in the Capital Region, Ballerup
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-19037864
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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