University of Bern
Bern, 3012, Switzerland
Location status: Recruiting
NCT Number: NCT07059234
This approach utilizes accelerometry to measure NEA and electronic diaries for real-time psychological assessments, overcoming limitations of traditional methods such as retrospective bias and low ecological validity. Brief episodes of physical activity in daily life, which are distinctly different from structured exercise sessions, are generally linked to improved affective well-being. Notably, feelings of energy are particularly associated with incidental, unstructured, and non-exercise activities. Clinically, psychomotor retardation and diminished mood are key diagnostic features of MDD, with evidence suggesting that lower motor activity differentiates MDD patients from controls and that increased activity correlates with treatment response. In this context, the MASE project aims to design personalized BA interventions that focus on increasing NEA and, in turn, enhancing subjective energy levels to reduce depressive symptoms and prevent relapse.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Bern, 3012, Switzerland
Location status: Recruiting
Mental health problems are increasing worldwide. Major depressive disorder (MDD) is considered the worldwide leading source of disability. Therapeutic approaches are not fully understood and still improvable.
Behavioral activation (BA), a successful therapeutic approach for nearly 50 years, increases activation by means of establishing short, and rewarding experiences in patients' daily life, e.g., taking a shower. Current research clearly supports the effects of BA on MDD when comparing it to no intervention. However, BA alone is not superior to other specific forms of psychotherapy. To improve BA, it is necessary to better understand the behavioral and neurobiological underpinnings. Most recently, researchers identified a new potential starting point for treating MDD: the momentary relationship between physical activity and feelings of energy in everyday life. While past research focused on exercise for treating MDD, newer studies have found that not sports (e.g., jogging) but everyday physical activity (e.g., walking stairs) improves energy. The investigators call this relationship ASEA (real-life physical activity-subjective energy association), which describes how people feel more energized and awake when moving. Secondly, we determined a specific region in the brain for ASEA and its relationship to mental health. ASEA is important from a clinical perspective: Reductions in physical activity and loss of energy symptoms affect patients most and even individuals with a history of MDD show reduced physical activity. Short interventions in patients' daily life tackling ASEA are likely to improve MDD prevention and treatment. However, it is unclear who (e.g., patients with specific brain properties) benefits most from which intervention (type of nonexercise activity, timing, location, context). For example, people with a certain brain structure may especially profit from a short slow walk with others in the morning to increase energy and reduce depression while people with another certain brain area may benefit from fast stair-climbing in the evening. Therefore, the investigators aim to a) apply brain network analyses to identify types of brains likely to profit from ASEA, (b) use artificial intelligence to identify where and when nonexercise activity helps people with certain brain properties, (c) conduct an experimental study to test if the intervention suggestions found in step (a) and (b) really work out in everyday life and (d) develop and design a smartphone app that delivers ASEA interventions and provides suggestions when and where to engage in which short nonexercise activity to maximize participation rates. In sum, the aim is to advance scientifically proven interventions by unraveling the neurobiological aspects and to tailor interventions to individuals for prevention and treatment of MDD.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 5-week intervention to assess the effects of non-exercise activity on the activity-subjective energy association incorporates two high-intensity Ambulatory Assessment (AA) weeks at the beginning and end, with a tapered 3-week Ecological Momentary Intervention (EMI) phase in between. Momentary targeted micro interventions (JITAIs) with a Within-Person-Encouragement Design (WPED) are used to tailor the activity to the individual situation and phenotype of each participant.
Time frame: pre-post intervention (at 5 weeks)
Subjective energy following target contexts will be assessed using the subscale Energetic Arousal from the MDMQ (VAS; scale from 0 to 100, with higher scores indicating higher energy levels).
Time frame: pre-post intervention (at 5 weeks)
Depression severity will be evaluated using the MADRS on a 7-point Likert-scale (with higher scores indicating more depressive symptoms)
Contact information is provided by the study sponsor or research team.
Claudio R. Nigg, Prof
CONTACT
Lea Nitzpon, M.Sc.
CONTACT
University of Bern
Other
The Motor Activity - Subjective Energy (MASE) Project: Neurobiological and Digital Phenotyping Towards Digital Mental Health Interventions in Depression
Acronym: MASE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07412756
Behavior, Behavioral Symptoms
Moorpark, California, United States
View Trial DetailsNCT06511908
Behavior, Behavioral Symptoms
Bethesda, Maryland, United States
View Trial DetailsNCT07227454
Depressive Disorder, Depressive Disorder, Major
Birmingham, Alabama, United States
View Trial DetailsNCT07573176
Depressive Disorder, Depressive Disorder, Major
Bellflower, California, United States
View Trial Details