- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05544877
An Energetic View on Creativity, Psychopathology and Intelligence: The Brain2Business Study (B2B)
An Energetic View on Creativity, Psychopathology and Intelligence: A Mixed Design Study in Adults With and Without Psychological Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
Creativity techniques aim to improve creative thinking and to resolve rigid thinking patterns. They are often recommended and used to generate new insights and perspectives in business and occupational contexts, e.g. to support business development. Despite its successful real-world use, research on the benefits of specific creativity techniques is still in its infancy and it is largely unknown which techniques work best in which contexts.
Most importantly, to the best of the investigators knowledge, (i) specifically designed creativity techniques are not part of any evidence-based psychotherapeutic technique, and (ii) have never been investigated to assist evidence-based psychotherapeutic techniques. Creativity techniques may be helpful in psychotherapy as creative thinking and the generation of new insights and perspectives are believed to be crucial for the efficiency of many psychotherapeutic methods such as cognitive-behavioral therapy and psychodynamic therapy. In addition, it is well-known that people with psychological disorders show less creative thinking, less flexibility and more rigidity in thinking and behavior.
This mixed interventional and observational study has two main aims. The interventional study aims to reveal the effect of a creativity technique - the Brain2Business (B2B) tool - on creative thinking, energy-related sensations and metabolism, technique adherence, gratefulness and goal-directed activation in two different psychotherapeutic techniques (idea generation for pleasurable activities within a behavioral activation therapy (PA-BA) and idea generation for a gratefulness exercise (GE)). As the primary outcome, the acute effect of B2B on creative thinking in adults with a psychological disorder are investigated. As secondary outcomes, the study focuses on the acute B2B effects on energy-related sensations (e.g. tiredness) and metabolism (e.g. heart rate variability) as well as on adherence to the psychotherapeutic techniques, gratefulness and goal-directed activation in adults with and without a psychological disorder.
The B2B tool is a specifically designed creativity technique and depicts a gamified conceptual combination approach. This approach has previously shown to have effects on originality of ideas and it is successfully used in real-world occupational contexts.
The main aim of the observational part of the study is to reveal the relationship between energy-related sensations (e.g., sensations of fatigue and energy), energy metabolism (e.g., heart rate variability, heart rate, core body temperature, skin temperature, blood pressure, cerebral oxygenation), psychopathology, intelligence, and creativity within the newly developed "c factor mito-bioenergetics" (CMB) model. It is a bioenergetic model that links psychopathology and intelligence. The CMB model (i) conceptualizes general cerebral function as the shared variance between intelligence and psychopathology and (ii) assumes that the body's energy metabolism is the biological underpinning of the co-variation between psychopathology and intelligence.
The study will reveal for the first time whether the creativity technique B2B has the potential to assist psychotherapeutic techniques. If the B2B tool efficiently supports creative thinking in psychotherapeutic techniques, clinical trials should follow that compare the psychological effects of a full creativity technique-assisted psychotherapy versus a treatment-as-usual psychotherapy. In addition, the study will evaluate the relation between energy-related sensations and metabolism and validate the CMB model.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Thurgau
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Münsterlingen, Thurgau, Switzerland, 8596
- Psychiatric Service Thurgau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Individuals with and without a diagnosed psychiatric disorder (lifetime or current)
Exclusion criteria:
- Acute suicidality
- Self-reported diagnosed neurological disorders that interfere with the study procedures
- Insufficient German language
- Vulnerable participants (e.g. participants with any indications for an incapability of judgement)
- Caffeine, tobacco consumption and physical activity two hours before the lab-based session starts (only for additional biomarker analyses)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brain2Business (B2B)
The Brain2Business (B2B) technique aims to improve creative thinking.
It is a game-based "conceptual combination" method that is performed by the participant with support of one trained B2B administrator in a laboratory session and without support in 5 at-home sessions.
In this technique, thirty-six different images are randomly selected on a board by throwing two dices.
Inspired by these images, participants are asked to create new ideas regarding three questions for a total of at least 39 minutes over a period of 5 days.
One question is from a standardized creativity test and two questions are part of psychotherapeutic techniques (idea generation for pleasurable activities within behavioral activation (PA-BA) and for a gratefulness exercise (GE)).
The B2B technique is based on the principles of solo brainstorming (SBS).
A trained B2B administrator is documenting the answers of the participant, and mentioning the principles of SBS (see SBS group).
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The 5-day intervention integrates a brief behavioral activation (BA) and a gratefulness exercise (GE) program.
BA is composed of a lab-based idea generation and planning phase as well as a home-based performing phase with regard to pleasurable activities.
GE is a idea generation task about aspects in life participants are grateful for about.
It is performed once lab-based and daily with a home-based diary.
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Active Comparator: Solo Brainstorming (SBS)
Solo brain storming (SBS) is the active control condition.
The technique aims to improve creative thinking through the principles of SBS.
SBS principles include i) idea quantity goes before quality, ii) no criticism and evaluation of ideas during idea generation, iii) original ideas are encouraged.
The principles are provided to participants in the same way, with the same questions to be answered, and over the same time period as in the B2B group.
A trained SBS administrator is documenting the answers of the participant, and mentioning the principles of SBS.
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The 5-day intervention integrates a brief behavioral activation (BA) and a gratefulness exercise (GE) program.
BA is composed of a lab-based idea generation and planning phase as well as a home-based performing phase with regard to pleasurable activities.
GE is a idea generation task about aspects in life participants are grateful for about.
It is performed once lab-based and daily with a home-based diary.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General creative thinking as assessed with the PTT creativity examination
Time Frame: Measured in the lab-session (time point 4)
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The PTT creativity examination measures general creative thinking in psychotherapeutic techniques (PTT) using a composite measure of a newly developed objective and self-reported creative thinking assessments across two PTT.
The composite score is calculated by averaging z-standardized objective and self-reported creative thinking assessments from both PTT.
The z-standardized outcome value has a mean of 0 and SD of 1 with a probable range between -3 and +3.
Higher scores mean a better outcome.
The assessment include the generated ideas (a) for pleasurable activities as a component of behavioral activation (PA-BA) and (b) for a gratefulness exercise (GE).
The score will be adjusted for baseline general creative thinking.
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Measured in the lab-session (time point 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective creative thinking as assessed with the PTT creativity examination - Objective creativity subscore
Time Frame: Measured in the lab-session (time point 4)
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The objective creativity subscore of the PTT creativity examination is measured with a composite score of fluency, flexibility and originality across different PTT.
The composite score is calculated by averaging z-standardized fluency, flexibility, and originality assessments from both PTT.
The examination is based on the Torrance Test of Creative Thinking.
The z-standardized outcome value has a mean of 0 and SD of 1 with a probable range between -3 and +3.
Higher scores mean a better outcome.
The score will be adjusted for baseline objective creative thinking.
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Measured in the lab-session (time point 4)
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Self-report creative thinking as assessed with the PTT creativity examination - Self-reported creativity subscore
Time Frame: Measured in the lab-session (time point 4)
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A self-reported creativity composite score about self-generated ideas across different PTT.
A newly developed self-report creativity assessment is used with 16 items using a 5-point Likert scale.
The sum score ranges from 0 to 64 points.
Higher scores mean a better outcome.
The score will be adjusted for baseline self-reported creativity (composite of creative self-efficacy and everyday life creativity assessment).
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Measured in the lab-session (time point 4)
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Top 3 creativity evaluation
Time Frame: Measured in the lab-session (time point 4)
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In the Top 3 creativity evaluation a lists of the best three items are rated on creativity by 2 raters.
A 5-point Likert scale is used and the sum score ranges from 0 to 15 points.
Higher scores mean a better outcome.
The score will be adjusted for baseline creative thinking.
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Measured in the lab-session (time point 4)
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PTT creativity examination - Originality subscore
Time Frame: Measured in the lab-session (time point 4)
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A composite measure of objective and self-reported originality.
The score will be adjusted for baseline creative thinking.
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Measured in the lab-session (time point 4)
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Eureka moment assessment
Time Frame: Measured in the lab-session (time point 4)
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A newly developed assessment that measures the number of Aha/eureka moments in both psychotherapeutic techniques
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Measured in the lab-session (time point 4)
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Torrance Test of Creative Thinking (TTCT) part II composite score
Time Frame: Measured in the lab-session (time point 4)
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The TTCT part II measures objective creative thinking within the elephant task of the TTCT; 4 minutes; part II).
The TTCT composite score is composed of a fluency, flexibility and originality score for the elefphant tasks.
The composite score is calculated by averaging z-standardized fluency, flexibility, and originality assessments.
The z-standardized outcome value has a mean of 0 and SD of 1 with a probable range between -3 and +3.
Higher scores mean a better outcome.
The score will be adjusted for baseline objective creative thinking using the TTCT part I without a creativity technique.
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Measured in the lab-session (time point 4)
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Everyday life creativity assessment
Time Frame: Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
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Everyday life creativity is assessed with a newly developed 5-item self-report questionnaire (5-point Likert scale).
The sum score ranges from 1 to 5.
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Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
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Creative self-efficacy
Time Frame: Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
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Creative self-efficacy is assessed with an adapted 6-item creative self-efficacy questionnaire based on two creative self-efficacy questionnaires (5-point Likert scale).
The sum score ranges from 6 to 30.
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Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
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Adherence to behavioral activation (BA) - planned activities
Time Frame: Measured in the lab-session (time point 4)
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Number of planned pleasurable activities during the 5-day diary period
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Measured in the lab-session (time point 4)
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Adherence to behavioral activation (BA) - performed activities
Time Frame: Measured home-based within the 5-day diary period (time point 5)
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Number of performed pleasurable activities during the 5-day diary period.
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Measured home-based within the 5-day diary period (time point 5)
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Adherence to gratefulness exercise (GE) - time
Time Frame: Measured home-based within the 5-day diary period (time point 5)
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The number of minutes people spend in the GE during the 5-day diary period
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Measured home-based within the 5-day diary period (time point 5)
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Adherence to gratefulness exercise (GE) - ideas
Time Frame: Measured home-based within the 5-day diary period (time point 5)
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The number of ideas people created in the GE during the 5-day diary period
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Measured home-based within the 5-day diary period (time point 5)
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Post-acute energy-related sensations as measured with the energy grid
Time Frame: Change within the 5-day diary period measured home-based (time point 5)
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Measured with two energy grid dimensions (wakefulness, sensation of energy) and derived composite scores using mean scores
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Change within the 5-day diary period measured home-based (time point 5)
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Bodily sensations of activation/deactivation and lightness/heaviness
Time Frame: Change from pre to post gratefulness exercise in the lab-session (time point 4)
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Measured with the emBody tool
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Change from pre to post gratefulness exercise in the lab-session (time point 4)
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Energy-related metabolism index - acute effects
Time Frame: Change within the lab-session (time point 2 to time point 4)
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A measure validated within the study based on a weighted composite score of all metabolism measures derived from beta coefficients of regression analysis or based on machine learning algorithm.
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Change within the lab-session (time point 2 to time point 4)
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Energy-related metabolism index - post-acute effects
Time Frame: Change from the lab-session to home-based assessment (time point 2 to time point 5)
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A measure validated within the study based on a weighted composite score of all metabolism measures derived from beta coefficients of regression analysis or based on machine learning algorithm.
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Change from the lab-session to home-based assessment (time point 2 to time point 5)
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Depressive symptoms as assessed Beck Depression Inventory II (BDI II)
Time Frame: Change from pre-test (time point 1) to the last day of the diary period (time point 5)
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The BDI II is a well-validated self-rating questionnaire of depression.
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Change from pre-test (time point 1) to the last day of the diary period (time point 5)
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Flow experiences in everyday life as assessed with the Brief Flow Scale (FKS).
Time Frame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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The FKS is a validated self-report questionnaire to assess flow experiences
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Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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General self-efficacy as assessed with the general self-efficacy brief scale (AKSU)
Time Frame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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The general self-efficacy brief scale (AKSU) is a validated self-report questionnaire to assess general self-efficacy
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Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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Gratefulness as assessed with the Gratitude questionnaire (GQ-5-G).
Time Frame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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The GQ-5-G is a validated self-report questionnaire to assess gratefulness
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Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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Creativity exercise experiences
Time Frame: Measured in the lab-session (time point 4)
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A composite measure based on the Game Experience Questionnaire - Core Module, the Energy Grid, and self-developed items.
Subscales include challenge - perceived effort, challenge - energy consumption, challenge - perceived task demand, boredomness, competence, pleasant feelings, calmness, sensation of energy, tiredness, match of resources and challenges, self-perceived creativity
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Measured in the lab-session (time point 4)
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Post-creativity exercise experiences as assessed with the Game Experience Questionnaire - post game module
Time Frame: Measured in the lab-session (time point 4)
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A composite measure based on the 4 subscales positive experience, negative experience, tiredness and returning to reality
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Measured in the lab-session (time point 4)
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Acute energy-related sensations
Time Frame: Change within the lab-based session from before the exercises (time point 2) to after each of the exercises (time point 4)
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A composite scores based on the Energy Grid's four dimensions (calmness, pleasant feelings, wakefulness, and sensation of energy).
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Change within the lab-based session from before the exercises (time point 2) to after each of the exercises (time point 4)
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Goal- and value-based activation
Time Frame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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Composite score of the activation subscale of the Behavioral Activation for Depression (BADS) questionnaire and a self-developed value-based activation questionnaire
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Change from pre-test (time point 2) to the last day of the diary period (time point 5)
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Physical activity
Time Frame: Change from pre-test (time point 2) to the diary period (time point 5)
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International physical activity questionnaire (IPAQ)
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Change from pre-test (time point 2) to the diary period (time point 5)
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Sleep quality
Time Frame: Change from pre-test (time point 2) to the diary period (time point 5)
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Insomnia scale of the Inventory of Depression and Anxiety Symptoms
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Change from pre-test (time point 2) to the diary period (time point 5)
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Positive/negative experience ratio
Time Frame: Measured at the last day of the diary period (time point 5)
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Ratio of remarkable positive and negative experiences during the 5-day period as measured with a self-developed questionnaire
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Measured at the last day of the diary period (time point 5)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Measured with Polar H10 sensor
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Core body temperature
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Measured with CORE/CALERAresearch device
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Blood oxygenation variability
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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SOMNOtouch™ RESP
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Variability of beat-to-beat diastolic and systolic blood pressure
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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SOMNOtouch™ RESP
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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24-hour peak-to-peak (maximum-minimum) core body temperature
Time Frame: Change from day 1 to day 3 in the home-based diary period
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Measured with CORE/CALERAresearch device
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Change from day 1 to day 3 in the home-based diary period
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Respiratory rate
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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SOMNOtouch™ RESP
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Thoracic/abdominal respiratory ratio
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Measured with SOMNOtouch™ RESP
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Cerebral oxygenation
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Sensmart model x-100 NIRS sensors from NONIN
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Cerebral oxygenation variability
Time Frame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Sensmart model x-100 NIRS sensors from NONIN
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Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rainer Krähenmann, PD, Psychiatrische Dienste Thurgau
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
- PDT_024_B2B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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