The Motor Activity - Subjective Energy (MASE) Project

Official title

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

Overview

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

• Behavioral Non-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.

Primary outcome measures

• Change of real-life physical activity-subjective energy association [Time frame: pre-post intervention (at 5 weeks)]

Secondary outcome measures (1)

• Change / stability in depressive symptoms in acute / remitted MDD patients [Time frame: pre-post intervention (at 5 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Switzerland · 1 center

• University of Bern — Bern

Publications

• Reichert M, Braun U, Gan G, Reinhard I, Giurgiu M, Ma R, Zang Z, Hennig O, Koch ED, Wieland L, Schweiger J, Inta D, Hoell A, Akdeniz C, Zipf A, Ebner-Priemer UW, Tost H, Meyer-Lindenberg A. A neural mechanism for affective well-being: Subgenual cingulate cortex mediates real-life effects of nonexercise activity on energy. Sci Adv. 2020 Nov 6;6(45):eaaz8934. doi: 10.1126/sciadv.aaz8934. Print 2020 PMID 33158875
• Reichert M, Braun U, Lautenbach S, Zipf A, Ebner-Priemer U, Tost H, Meyer-Lindenberg A. Studying the impact of built environments on human mental health in everyday life: methodological developments, state-of-the-art and technological frontiers. Curr Opin Psychol. 2020 Apr;32:158-164. doi: 10.1016/j.copsyc.2019.08.026. Epub 2019 Sep 9. PMID 31610407
• Reichert M, Tost H, Reinhard I, Schlotz W, Zipf A, Salize HJ, Meyer-Lindenberg A, Ebner-Priemer UW. Exercise versus Nonexercise Activity: E-diaries Unravel Distinct Effects on Mood. Med Sci Sports Exerc. 2017 Apr;49(4):763-773. doi: 10.1249/MSS.0000000000001149. PMID 27824691
• Schmiedek F, Neubauer AB. Experiments in the Wild: Introducing the Within-Person Encouragement Design. Multivariate Behav Res. 2020 Mar-Apr;55(2):256-276. doi: 10.1080/00273171.2019.1627660. Epub 2019 Jul 2. PMID 31264902
• Abdoli N, Salari N, Darvishi N, Jafarpour S, Solaymani M, Mohammadi M, Shohaimi S. The global prevalence of major depressive disorder (MDD) among the elderly: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2022 Jan;132:1067-1073. doi: 10.1016/j.neubiorev.2021.10.041. Epub 2021 Nov 4. PMID 34742925
• Biagianti B, Foti G, Di Liberto A, Bressi C, Brambilla P. CBT-informed psychological interventions for adult patients with anxiety and depression symptoms: A narrative review of digital treatment options. J Affect Disord. 2023 Mar 15;325:682-694. doi: 10.1016/j.jad.2023.01.057. Epub 2023 Jan 20. PMID 36690081
• Furukawa TA, Suganuma A, Ostinelli EG, Andersson G, Beevers CG, Shumake J, Berger T, Boele FW, Buntrock C, Carlbring P, Choi I, Christensen H, Mackinnon A, Dahne J, Huibers MJH, Ebert DD, Farrer L, Forand NR, Strunk DR, Ezawa ID, Forsell E, Kaldo V, Geraedts A, Gilbody S, Littlewood E, Brabyn S, Hadjistavropoulos HD, Schneider LH, Johansson R, Kenter R, Kivi M, Bjorkelund C, Kleiboer A, Riper H, K PMID 33957075
• Heinz A, Kiefer F, Smolka MN, Endrass T, Beste C, Beck A, Liu S, Genauck A, Romund L, Banaschewski T, Bermpohl F, Deserno L, Dolan RJ, Durstewitz D, Ebner-Priemer U, Flor H, Hansson AC, Heim C, Hermann D, Kiebel S, Kirsch P, Kirschbaum C, Koppe G, Marxen M, Meyer-Lindenberg A, Nagel WE, Noori HR, Pilhatsch M, Priller J, Rietschel M, Romanczuk-Seiferth N, Schlagenhauf F, Sommer WH, Stallkamp J, Str PMID 31859437

Identifiers

NCT: NCT07059234 · 2025-00691

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗