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

Fatigue Clinical Trial

— B2B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05544877
• Other study ID #: PDT_024_B2B
• Status: Completed
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: October 2023
• Source: Psychiatrische Dienste Thurgau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 4, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Fatigue
• General Psychopathology

Intervention

Behavioral:
• Integrated 5-day Gratitude Exercise and Behavioral Activation Program
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.

Locations

Country	Name	City	State
Switzerland	Psychiatric Service Thurgau	Münsterlingen	Thurgau

Sponsors (4)

Lead Sponsor	Collaborator
Psychiatrische Dienste Thurgau	Brain2Go AG, greenTEG AG, SOMNOmedics GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate variability	Measured with Polar H10 sensor	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Core body temperature	Measured with CORE/CALERAresearch device	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Blood oxygenation variability	SOMNOtouch™ RESP	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Variability of beat-to-beat diastolic and systolic blood pressure	SOMNOtouch™ RESP	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	24-hour peak-to-peak (maximum-minimum) core body temperature	Measured with CORE/CALERAresearch device	Change from day 1 to day 3 in the home-based diary period
Other	Respiratory rate	SOMNOtouch™ RESP	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Thoracic/abdominal respiratory ratio	Measured with SOMNOtouch™ RESP	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Cerebral oxygenation	Sensmart model x-100 NIRS sensors from NONIN	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Other	Cerebral oxygenation variability	Sensmart model x-100 NIRS sensors from NONIN	Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Physical activity	International physical activity questionnaire (IPAQ)	Change from pre-test (time point 2) to the diary period (time point 5)
Secondary	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)
Secondary	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)