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Trial · NCT03615651

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in brain response to validated emotional challenge task (EAT) during functional brain imagingComparing week 4 and 12
SecondaryChange in brain response to a cognitive challenge task (MIST) during functional brain imagingComparing week 4 and 12
OtherChange in physical activity assessed by an actigraphy watch (actiwatch)Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Actigraph data regarding physical activity
OtherChange in sleep quality assessed by an actigraphy watch (actiwatch)Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Actigraph data regarding sleep quality
OtherChange in daily stress levels assessed by an actigraphy watch (actiwatch)Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Actigraph data regarding daily stress levels
OtherAutonomous Nervous System (ANS) Activity, BiopacComparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)ANS activity is measures during stressful tasks.
OtherStroop testComparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)The Stroop test is performed for stress induction
OtherHADS (Hospital Anxiety and Depression Scale)Measured weekly, week 1-12Hospital Anxiety and Depression Scale, min score 0, max score 3, total score max 42, subscale anxiety max 21, subscale depression max 21
OtherSTAI (State and Trait Anxiety Inventory for Adults)Measured weekly, week 1-12State and Trait Anxiety Inventory for Adults
OtherPSS (Perceived Stress Scale)Measured weekly, week 1-12Perceived Stress Scale, min score 0, max score 40
OtherEuro-QoLMeasured weekly, week 1-12Euro Qol- Health-related Quality of Life 5Q-5D-5L, min score 0, max score 20, subscale 0-100
OtherKarolinska Sleep Diary (KSD)Measured daily, week 1-4 and 8-12KSD measures sleep quality in the morning
OtherKarolinska Diary of Workload (KDW)Measured daily, week 1-4 and 8-12KDW measures workload daily in the evening
OtherCortisol levels during fMRI tasks (Saliva)Comparing week 4 and 12Saliva samples are collected during fMRI to assess cortisol levels
OtherCortisol awakening rhythm (saliva)Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Saliva samples are collected at home (3 days á 5 samples) to assess cortisol levels
OtherFaecal samplesComparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Faecal samples will be analyzed for quantitative and qualitative microbial composition by 16S rRNA-based next generation sequencing (NGS)
OtherChange in inflammatory markersComparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)Blood samples will be collected after each intervention period to assess inflammatory markers using Enzyme-Linked Immunosorbent Assays (ELISA)s

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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