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

NCT05544877 | Completed

• 1 other identifier: PDT_024_B2B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Objective creative thinking as assessed with the PTT creativity examination - Objective creativity subscore

  Measured in the lab-session (time point 4)

• Self-report creative thinking as assessed with the PTT creativity examination - Self-reported creativity subscore

  Measured in the lab-session (time point 4)

• Top 3 creativity evaluation

  Measured in the lab-session (time point 4)

• PTT creativity examination - Originality subscore

  Measured in the lab-session (time point 4)

• Eureka moment assessment

  Measured in the lab-session (time point 4)

Other Outcomes (9)

• Heart rate variability

  Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session

• Core body temperature

  Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session

• Blood oxygenation variability

  Change from baseline (time point 2) to exercise tasks (time point 4) within the lab-based session

Study Arms (2)

Brain2Business (B2B)

EXPERIMENTAL

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

Solo Brainstorming (SBS)

ACTIVE COMPARATOR

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

Interventions

Integrated 5-day Gratitude Exercise and Behavioral Activation Program BEHAVIORAL

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.

Brain2Business (B2B); Solo Brainstorming (SBS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with and without a diagnosed psychiatric disorder (lifetime or current)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Psychiatrische Dienste Thurgau: lead
• Brain2Go AG: collaborator
• greenTEG AG: collaborator
• SOMNOmedics GmbH: collaborator

Study Sites (1)

Psychiatric Service Thurgau

Münsterlingen, Thurgau, 8596, Switzerland

Location

MeSH Terms

Conditions

Fatigue; Depressive Disorder, Major; Depression; Somatoform Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rainer Krähenmann, PD

  Psychiatrische Dienste Thurgau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director of Psychiatric Services Thurgau (PD Dr.)

Model Details: 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).

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: September 19, 2022
• Study Start: July 19, 2022
• Primary Completion: September 29, 2023
• Study Completion: October 4, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CH (1)