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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Energetic View on Creativity, Psychopathology and Intelligence: A Mixed Design Study in Adults With and Without Psychological Disorders

Conditions
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General Psychopathology, Fatigue, Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Integrated 5-day Gratitude Exercise and Behavioral Activation Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain2Business (B2B)<br>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). | Behavioral: Integrated 5-day Gratitude Exercise and Behavioral Activation Program<br>* 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.<br>|
| Active Comparator: Solo Brainstorming (SBS)<br>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. | Behavioral: Integrated 5-day Gratitude Exercise and Behavioral Activation Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured in the lab-session (time point 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured in the lab-session (time point 4) | 
| 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). | Measured in the lab-session (time point 4) | 
| 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. | Measured in the lab-session (time point 4) | 
| PTT creativity examination - Originality subscore | A composite measure of objective and self-reported originality. The score will be adjusted for baseline creative thinking. | Measured in the lab-session (time point 4) | 
| Eureka moment assessment | A newly developed assessment that measures the number of Aha/eureka moments in both psychotherapeutic techniques | Measured in the lab-session (time point 4) | 
| 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. | Measured in the lab-session (time point 4) | 
| 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. | Change from pre-test (time point 2) to 1-week-follow-up (time point 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. | Change from pre-test (time point 2) to 1-week-follow-up (time point 5) | 
| Adherence to behavioral activation (BA) - planned activities | Number of planned pleasurable activities during the 5-day diary period | Measured in the lab-session (time point 4) | 
| Adherence to behavioral activation (BA) - performed activities | Number of performed pleasurable activities during the 5-day diary period. | Measured home-based within the 5-day diary period (time point 5) | 
| Adherence to gratefulness exercise (GE) - time | The number of minutes people spend in the GE during the 5-day diary period | Measured home-based within the 5-day diary period (time point 5) | 
| Adherence to gratefulness exercise (GE) - ideas | The number of ideas people created in the GE during the 5-day diary period | Measured home-based within the 5-day diary period (time point 5) | 
| 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 | Change within the 5-day diary period measured home-based (time point 5) | 
| Bodily sensations of activation/deactivation and lightness/heaviness | Measured with the emBody tool | Change from pre to post gratefulness exercise in the lab-session (time point 4) | 
| 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. | Change within the lab-session (time point 2 to time point 4) | 
| 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. | Change from the lab-session to home-based assessment (time point 2 to time point 5) | 
| Depressive symptoms as assessed Beck Depression Inventory II (BDI II) | The BDI II is a well-validated self-rating questionnaire of depression. | Change from pre-test (time point 1) to the last day of the diary period (time point 5) | 
| 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 | Change from pre-test (time point 2) to the last day of the diary period (time point 5) | 
| 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 | Change from pre-test (time point 2) to the last day of the diary period (time point 5) | 
| Gratefulness as assessed with the Gratitude questionnaire (GQ-5-G). | The GQ-5-G is a validated self-report questionnaire to assess gratefulness | Change from pre-test (time point 2) to the last day of the diary period (time point 5) | 
| 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 | Measured in the lab-session (time point 4) | 
| 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 | Measured in the lab-session (time point 4) | 
| Acute energy-related sensations | A composite scores based on the Energy Grid's four dimensions (calmness, pleasant feelings, wakefulness, and sensation of energy). | Change within the lab-based session from before the exercises (time point 2) to after each of the exercises (time point 4) | 
| 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 | Change from pre-test (time point 2) to the last day of the diary period (time point 5) | 
| Physical activity | International physical activity questionnaire (IPAQ) | Change from pre-test (time point 2) to the diary period (time point 5) | 
| Sleep quality | Insomnia scale of the Inventory of Depression and Anxiety Symptoms | Change from pre-test (time point 2) to the diary period (time point 5) | 
| Positive/negative experience ratio | Ratio of remarkable positive and negative experiences during the 5-day period as measured with a self-developed questionnaire | Measured at the last day of the diary period (time point 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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