Clinical trial NCT05544877: An Energetic View on Creativity, Psychopathology and Intelligence: The Brain2Business Study
Official title: An Energetic View on Creativity, Psychopathology and Intelligence: A Mixed Design Study in Adults With and Without Psychological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Psychiatrische Dienste Thurgau
Sponsor class: OTHER
Collaborators: name: Brain2Go AG
name: greenTEG AG
name: SOMNOmedics GmbH
First posted: 2022-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: General creative thinking as assessed with the PTT creativity examination
timeFrame: Measured in the lab-session (time point 4)
Secondary outcomes:
measure: Objective creative thinking as assessed with the PTT creativity examination - Objective creativity subscore
timeFrame: Measured in the lab-session (time point 4)
measure: Self-report creative thinking as assessed with the PTT creativity examination - Self-reported creativity subscore
timeFrame: Measured in the lab-session (time point 4)
measure: Top 3 creativity evaluation
timeFrame: Measured in the lab-session (time point 4)
measure: PTT creativity examination - Originality subscore
timeFrame: Measured in the lab-session (time point 4)
measure: Eureka moment assessment
timeFrame: Measured in the lab-session (time point 4)
measure: Torrance Test of Creative Thinking (TTCT) part II composite score
timeFrame: Measured in the lab-session (time point 4)
measure: Everyday life creativity assessment
timeFrame: Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
measure: Creative self-efficacy
timeFrame: Change from pre-test (time point 2) to 1-week-follow-up (time point 5)
measure: Adherence to behavioral activation (BA) - planned activities
timeFrame: Measured in the lab-session (time point 4)
measure: Adherence to behavioral activation (BA) - performed activities
timeFrame: Measured home-based within the 5-day diary period (time point 5)
measure: Adherence to gratefulness exercise (GE) - time
timeFrame: Measured home-based within the 5-day diary period (time point 5)
measure: Adherence to gratefulness exercise (GE) - ideas
timeFrame: Measured home-based within the 5-day diary period (time point 5)
measure: Post-acute energy-related sensations as measured with the energy grid
timeFrame: Change within the 5-day diary period measured home-based (time point 5)
measure: Bodily sensations of activation/deactivation and lightness/heaviness
timeFrame: Change from pre to post gratefulness exercise in the lab-session (time point 4)
measure: Energy-related metabolism index - acute effects
timeFrame: Change within the lab-session (time point 2 to time point 4)
measure: Energy-related metabolism index - post-acute effects
timeFrame: Change from the lab-session to home-based assessment (time point 2 to time point 5)
measure: Depressive symptoms as assessed Beck Depression Inventory II (BDI II)
timeFrame: Change from pre-test (time point 1) to the last day of the diary period (time point 5)
measure: Flow experiences in everyday life as assessed with the Brief Flow Scale (FKS).
timeFrame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
measure: General self-efficacy as assessed with the general self-efficacy brief scale (AKSU)
timeFrame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
measure: Gratefulness as assessed with the Gratitude questionnaire (GQ-5-G).
timeFrame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
measure: Creativity exercise experiences
timeFrame: Measured in the lab-session (time point 4)
measure: Post-creativity exercise experiences as assessed with the Game Experience Questionnaire - post game module
timeFrame: Measured in the lab-session (time point 4)
measure: Acute energy-related sensations
timeFrame: Change within the lab-based session from before the exercises (time point 2) to after each of the exercises (time point 4)
measure: Goal- and value-based activation
timeFrame: Change from pre-test (time point 2) to the last day of the diary period (time point 5)
measure: Physical activity
timeFrame: Change from pre-test (time point 2) to the diary period (time point 5)
measure: Sleep quality
timeFrame: Change from pre-test (time point 2) to the diary period (time point 5)
measure: Positive/negative experience ratio
timeFrame: Measured at the last day of the diary period (time point 5)
Other outcomes:
measure: Heart rate variability
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Core body temperature
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Blood oxygenation variability
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Variability of beat-to-beat diastolic and systolic blood pressure
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: 24-hour peak-to-peak (maximum-minimum) core body temperature
timeFrame: Change from day 1 to day 3 in the home-based diary period
measure: Respiratory rate
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Thoracic/abdominal respiratory ratio
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Cerebral oxygenation
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
measure: Cerebral oxygenation variability
timeFrame: Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session
Locations:
city: Münsterlingen
country: Switzerland
facility: Psychiatric Service Thurgau
state: Thurgau
Study officials:
affiliation: Psychiatrische Dienste Thurgau
name: Rainer Krähenmann, PD
role: PRINCIPAL_INVESTIGATOR
References: