search
Back to results

An Energetic View on Creativity, Psychopathology and Intelligence: The Brain2Business Study (B2B)

Primary Purpose

General Psychopathology, Fatigue, Depressive Disorder, Major

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Integrated 5-day Gratitude Exercise and Behavioral Activation Program
Sponsored by
Psychiatrische Dienste Thurgau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for General Psychopathology focused on measuring General psychopathology, Fatigue, Depression, somatoform disorders, Internalizing disorders, Thought disorders, Detachment disorders, Disinhibited externalizing disorders, Antagonistic externalizing disorders, Behavioral Activation, Gratefulness exercise, Creativity technique, Brain2Business, Solo Brainstorming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Psychiatric Service ThurgauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brain2Business (B2B)

Solo Brainstorming (SBS)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

General creative thinking as assessed with the PTT creativity examination
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.

Secondary Outcome Measures

Objective creative thinking as assessed with the PTT creativity examination - Objective creativity subscore
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.
Self-report creative thinking as assessed with the PTT creativity examination - Self-reported creativity subscore
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).
Top 3 creativity evaluation
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.
PTT creativity examination - Originality subscore
A composite measure of objective and self-reported originality. The score will be adjusted for baseline creative thinking.
Eureka moment assessment
A newly developed assessment that measures the number of Aha/eureka moments in both psychotherapeutic techniques
Torrance Test of Creative Thinking (TTCT) part II composite score
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.
Everyday life creativity assessment
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.
Creative self-efficacy
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.
Adherence to behavioral activation (BA) - planned activities
Number of planned pleasurable activities during the 5-day diary period
Adherence to behavioral activation (BA) - performed activities
Number of performed pleasurable activities during the 5-day diary period.
Adherence to gratefulness exercise (GE) - time
The number of minutes people spend in the GE during the 5-day diary period
Adherence to gratefulness exercise (GE) - ideas
The number of ideas people created in the GE during the 5-day diary period
Post-acute energy-related sensations as measured with the energy grid
Measured with two energy grid dimensions (wakefulness, sensation of energy) and derived composite scores using mean scores
Bodily sensations of activation/deactivation and lightness/heaviness
Measured with the emBody tool
Energy-related metabolism index - acute effects
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.
Energy-related metabolism index - post-acute effects
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.
Depressive symptoms as assessed Beck Depression Inventory II (BDI II)
The BDI II is a well-validated self-rating questionnaire of depression.
Flow experiences in everyday life as assessed with the Brief Flow Scale (FKS).
The FKS is a validated self-report questionnaire to assess flow experiences
General self-efficacy as assessed with the general self-efficacy brief scale (AKSU)
The general self-efficacy brief scale (AKSU) is a validated self-report questionnaire to assess general self-efficacy
Gratefulness as assessed with the Gratitude questionnaire (GQ-5-G).
The GQ-5-G is a validated self-report questionnaire to assess gratefulness
Creativity exercise experiences
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
Post-creativity exercise experiences as assessed with the Game Experience Questionnaire - post game module
A composite measure based on the 4 subscales positive experience, negative experience, tiredness and returning to reality
Acute energy-related sensations
A composite scores based on the Energy Grid's four dimensions (calmness, pleasant feelings, wakefulness, and sensation of energy).
Goal- and value-based activation
Composite score of the activation subscale of the Behavioral Activation for Depression (BADS) questionnaire and a self-developed value-based activation questionnaire
Physical activity
International physical activity questionnaire (IPAQ)
Sleep quality
Insomnia scale of the Inventory of Depression and Anxiety Symptoms
Positive/negative experience ratio
Ratio of remarkable positive and negative experiences during the 5-day period as measured with a self-developed questionnaire

Full Information

First Posted
July 30, 2022
Last Updated
September 15, 2022
Sponsor
Psychiatrische Dienste Thurgau
Collaborators
Brain2Go AG, greenTEG AG, SOMNOmedics GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT05544877
Brief Title
An Energetic View on Creativity, Psychopathology and Intelligence: The Brain2Business Study
Acronym
B2B
Official Title
An Energetic View on Creativity, Psychopathology and Intelligence: A Mixed Design Study in Adults With and Without Psychological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatrische Dienste Thurgau
Collaborators
Brain2Go AG, greenTEG AG, SOMNOmedics GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The interventional part of the study aims to assess the acute effect of the Brain2Business (B2B) tool on creative thinking (primary objective) in adults with psychological disorders. Additionally, the study assesses the B2B effects on energy-related sensations and metabolism, technique adherence, gratefulness and goal-directed activation (secondary objectives) in adults with and without psychological disorders. The observational part of the study primarily aims to investigate the link between psychopathology, intelligence, energy-related sensations and metabolism validating the "c factor mito-bioenergetics" (CMB) model in a sample of adults with and without psychological disorders.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Psychopathology, Fatigue, Depressive Disorder, Major
Keywords
General psychopathology, Fatigue, Depression, somatoform disorders, Internalizing disorders, Thought disorders, Detachment disorders, Disinhibited externalizing disorders, Antagonistic externalizing disorders, Behavioral Activation, Gratefulness exercise, Creativity technique, Brain2Business, Solo Brainstorming

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned in blocks of 20 and stratified for psychological disorder (with/without self-reported lifetime or current diagnosis of a psychological disorder) to one of two creativity technique conditions (Brain2Business vs Solo Brainstorming).
Masking
Participant
Masking Description
Based on the behavioral intervention, the administrator of the intervention who is intrinsically also the outcome assessor of the primary outcome cannot be masked. Participants are masked as they are not aware about their treatment condition. Self-rated questionnaire-based outcome measures are not subject to bias as participants are masked.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain2Business (B2B)
Arm Type
Experimental
Arm Description
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).
Arm Title
Solo Brainstorming (SBS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated 5-day Gratitude Exercise and Behavioral Activation Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
General creative thinking as assessed with the PTT creativity examination
Description
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.
Time Frame
Measured in the lab-session (time point 4)
Secondary Outcome Measure Information:
Title
Objective creative thinking as assessed with the PTT creativity examination - Objective creativity subscore
Description
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.
Time Frame
Measured in the lab-session (time point 4)
Title
Self-report creative thinking as assessed with the PTT creativity examination - Self-reported creativity subscore
Description
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).
Time Frame
Measured in the lab-session (time point 4)
Title
Top 3 creativity evaluation
Description
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.
Time Frame
Measured in the lab-session (time point 4)
Title
PTT creativity examination - Originality subscore
Description
A composite measure of objective and self-reported originality. The score will be adjusted for baseline creative thinking.
Time Frame
Measured in the lab-session (time point 4)
Title
Eureka moment assessment
Description
A newly developed assessment that measures the number of Aha/eureka moments in both psychotherapeutic techniques
Time Frame
Measured in the lab-session (time point 4)
Title
Torrance Test of Creative Thinking (TTCT) part II composite score
Description
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.
Time Frame
Measured in the lab-session (time point 4)
Title
Everyday life creativity assessment
Description
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.
Time Frame
Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
Title
Creative self-efficacy
Description
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.
Time Frame
Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
Title
Adherence to behavioral activation (BA) - planned activities
Description
Number of planned pleasurable activities during the 5-day diary period
Time Frame
Measured in the lab-session (time point 4)
Title
Adherence to behavioral activation (BA) - performed activities
Description
Number of performed pleasurable activities during the 5-day diary period.
Time Frame
Measured home-based within the 5-day diary period (time point 5)
Title
Adherence to gratefulness exercise (GE) - time
Description
The number of minutes people spend in the GE during the 5-day diary period
Time Frame
Measured home-based within the 5-day diary period (time point 5)
Title
Adherence to gratefulness exercise (GE) - ideas
Description
The number of ideas people created in the GE during the 5-day diary period
Time Frame
Measured home-based within the 5-day diary period (time point 5)
Title
Post-acute energy-related sensations as measured with the energy grid
Description
Measured with two energy grid dimensions (wakefulness, sensation of energy) and derived composite scores using mean scores
Time Frame
Change within the 5-day diary period measured home-based (time point 5)
Title
Bodily sensations of activation/deactivation and lightness/heaviness
Description
Measured with the emBody tool
Time Frame
Change from pre to post gratefulness exercise in the lab-session (time point 4)
Title
Energy-related metabolism index - acute effects
Description
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.
Time Frame
Change within the lab-session (time point 2 to time point 4)
Title
Energy-related metabolism index - post-acute effects
Description
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.
Time Frame
Change from the lab-session to home-based assessment (time point 2 to time point 5)
Title
Depressive symptoms as assessed Beck Depression Inventory II (BDI II)
Description
The BDI II is a well-validated self-rating questionnaire of depression.
Time Frame
Change from pre-test (time point 1) to the last day of the diary period (time point 5)
Title
Flow experiences in everyday life as assessed with the Brief Flow Scale (FKS).
Description
The FKS is a validated self-report questionnaire to assess flow experiences
Time Frame
Change from pre-test (time point 2) to the last day of the diary period (time point 5)
Title
General self-efficacy as assessed with the general self-efficacy brief scale (AKSU)
Description
The general self-efficacy brief scale (AKSU) is a validated self-report questionnaire to assess general self-efficacy
Time Frame
Change from pre-test (time point 2) to the last day of the diary period (time point 5)
Title
Gratefulness as assessed with the Gratitude questionnaire (GQ-5-G).
Description
The GQ-5-G is a validated self-report questionnaire to assess gratefulness
Time Frame
Change from pre-test (time point 2) to the last day of the diary period (time point 5)
Title
Creativity exercise experiences
Description
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
Time Frame
Measured in the lab-session (time point 4)
Title
Post-creativity exercise experiences as assessed with the Game Experience Questionnaire - post game module
Description
A composite measure based on the 4 subscales positive experience, negative experience, tiredness and returning to reality
Time Frame
Measured in the lab-session (time point 4)
Title
Acute energy-related sensations
Description
A composite scores based on the Energy Grid's four dimensions (calmness, pleasant feelings, wakefulness, and sensation of energy).
Time Frame
Change within the lab-based session from before the exercises (time point 2) to after each of the exercises (time point 4)
Title
Goal- and value-based activation
Description
Composite score of the activation subscale of the Behavioral Activation for Depression (BADS) questionnaire and a self-developed value-based activation questionnaire
Time Frame
Change from pre-test (time point 2) to the last day of the diary period (time point 5)
Title
Physical activity
Description
International physical activity questionnaire (IPAQ)
Time Frame
Change from pre-test (time point 2) to the diary period (time point 5)
Title
Sleep quality
Description
Insomnia scale of the Inventory of Depression and Anxiety Symptoms
Time Frame
Change from pre-test (time point 2) to the diary period (time point 5)
Title
Positive/negative experience ratio
Description
Ratio of remarkable positive and negative experiences during the 5-day period as measured with a self-developed questionnaire
Time Frame
Measured at the last day of the diary period (time point 5)
Other Pre-specified Outcome Measures:
Title
Heart rate variability
Description
Measured with Polar H10 sensor
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Core body temperature
Description
Measured with CORE/CALERAresearch device
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Blood oxygenation variability
Description
SOMNOtouch™ RESP
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Variability of beat-to-beat diastolic and systolic blood pressure
Description
SOMNOtouch™ RESP
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
24-hour peak-to-peak (maximum-minimum) core body temperature
Description
Measured with CORE/CALERAresearch device
Time Frame
Change from day 1 to day 3 in the home-based diary period
Title
Respiratory rate
Description
SOMNOtouch™ RESP
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Thoracic/abdominal respiratory ratio
Description
Measured with SOMNOtouch™ RESP
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Cerebral oxygenation
Description
Sensmart model x-100 NIRS sensors from NONIN
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Title
Cerebral oxygenation variability
Description
Sensmart model x-100 NIRS sensors from NONIN
Time Frame
Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Krähenmann, PD
Phone
+41 71 686 4020
Email
rainer.kraehenmann@stgag.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Fissler, Dr
Phone
+41 71 686 4347
Email
patrick.fissler@stgag.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Krähenmann, PD
Organizational Affiliation
Psychiatrische Dienste Thurgau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Service Thurgau
City
Münsterlingen
State/Province
Thurgau
ZIP/Postal Code
8596
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Krähenmann, PD
Phone
+41 71 686 4020
Email
rainer.kraehenmann@stgag.ch
First Name & Middle Initial & Last Name & Degree
Patrick Fissler, Dr
Phone
+41 71 686 4347
Email
patrick.fissler@stgag.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is not decided because of ethical considerations. If no ethical reasons avoid it, data is planned to be shared.

Learn more about this trial

An Energetic View on Creativity, Psychopathology and Intelligence: The Brain2Business Study

We'll reach out to this number within 24 hrs