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The Motor Activity - Subjective Energy (MASE) Project

The Motor Activity - Subjective Energy (MASE) Project: Neurobiological and Digital Phenotyping Towards Digital Mental Health Interventions in Depression

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07059234
Acronym
MASE
Enrollment
180
Registered
2025-07-10
Start date
2025-09-02
Completion date
2027-04-30
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALNon-exercise activity

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.

Sponsors

University of Salzburg
CollaboratorOTHER
University of Wuerzburg
CollaboratorOTHER
University of Mannheim
CollaboratorOTHER
University of Ostrava
CollaboratorOTHER
University of Deusto
CollaboratorOTHER
University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Ambulatory Assessment, Within-Person-Encouragement-Design

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Sufficient knowledge of the German language * Written informed consent. * Score \> 15 on the Montgomery Asberg Depression rating scale (MADRS) for MDD group. * Remission within the past year and exhibit a MADRS score \< 10 for at least one month for rMDD group

Exclusion criteria

* Pregnancy at baseline * Claustrophobia * Pacemaker * Artificial heart valves * Active implants * Other psychiatric disorders * Acute suicidality, change of medication / psychotherapy during the intervention (not dosage but substance). * For healthy participants: history of any mental health condition or first-degree relative with affective / psychotic disorder

Design outcomes

Primary

MeasureTime frameDescription
Change of real-life physical activity-subjective energy associationpre-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).

Secondary

MeasureTime frameDescription
Change / stability in depressive symptoms in acute / remitted MDD patientspre-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)

Countries

Switzerland

Contacts

Primary ContactClaudio R. Nigg, Prof
claudio.nigg@unibe.ch0041316844188
Backup ContactLea Nitzpon, M.Sc.
lea.nitzpon@unibe.ch0041316845106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026