The Motor Activity - Subjective Energy (MASE) Project

NCT07059234 | Recruiting DMC

• 1 other identifier: 2025-00691
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change of real-life physical activity-subjective energy association

  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).

  pre-post intervention (at 5 weeks)

Secondary Outcomes (1)

• Change / stability in depressive symptoms in acute / remitted MDD patients

  pre-post intervention (at 5 weeks)

Study Arms (3)

A, 50%

EXPERIMENTAL

The investigators will compare the physical activity just-in-Time Adaptive Interventions (JITAI) to an active control working memory task within participants. There will be 4 triggers in total. Ratio intervention / active control = 2:2

Behavioral: Non-exercise activity

B, 75%

EXPERIMENTAL

The investigators will compare the physical activity just-in-Time Adaptive Interventions (JITAI) to an active control working memory task within participants.There will be 4 triggers in total. Ratio intervention / active control = 3:1

Behavioral: Non-exercise activity

C, 25%

EXPERIMENTAL

Intervention for the control group (healthy participants) is the same as for the other groups. We will compare the physical activity just-in-Time Adaptive Interventions (JITAI) to an active control working memory task within participants. There will be 4 triggers in total. Ratio intervention / active control = 1:3

Behavioral: Non-exercise activity

Interventions

Non-exercise activity BEHAVIORAL

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.

A, 50%; B, 75%; C, 25%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• University of Salzburg: collaborator
• University of Wuerzburg: collaborator
• University of Mannheim: collaborator
• University of Ostrava: collaborator
• University of Deusto: collaborator

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

RECRUITING

Related Publications (15)

• 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 Nov.

  PMID: 33158875 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Klein JP, Schroder J, Meyer B, Moritz S, Bucker L, Lintvedt O, Johansson P, Lundgren J, Milgrom J, Gemmill AW, Mohr DC, Montero-Marin J, Garcia-Campayo J, Nobis S, Zarski AC, O'Moore K, Williams AD, Newby JM, Perini S, Phillips R, Schneider J, Pots W, Pugh NE, Richards D, Rosso IM, Rauch SL, Sheeber LB, Smith J, Spek V, Pop VJ, Unlu B, van Bastelaar KMP, van Luenen S, Garnefski N, Kraaij V, Vernmark K, Warmerdam L, van Straten A, Zagorscak P, Knaevelsrud C, Heinrich M, Miguel C, Cipriani A, Efthimiou O, Karyotaki E, Cuijpers P. Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data. Lancet Psychiatry. 2021 Jun;8(6):500-511. doi: 10.1016/S2215-0366(21)00077-8. Epub 2021 May 3.

  PMID: 33957075 BACKGROUND

• 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, Strohle A, Stock AK, Winterer G, Winter C, Walter H, Witt S, Vollstadt-Klein S, Rapp MA, Tost H, Spanagel R. Addiction Research Consortium: Losing and regaining control over drug intake (ReCoDe)-From trajectories to mechanisms and interventions. Addict Biol. 2020 Mar;25(2):e12866. doi: 10.1111/adb.12866. Epub 2019 Dec 20.

  PMID: 31859437 BACKGROUND

• Kanning MK, Ebner-Priemer UW, Schlicht WM. How to Investigate Within-Subject Associations between Physical Activity and Momentary Affective States in Everyday Life: A Position Statement Based on a Literature Overview. Front Psychol. 2013 Apr 29;4:187. doi: 10.3389/fpsyg.2013.00187. eCollection 2013.

  PMID: 23641221 BACKGROUND

• Liu S, Haucke M, Gross R, Schneider K, Shin J, Arntz F, Bach P, Banaschewski T, Beste C, Deserno L, Ebner-Priemer U, Endrass T, Ganz M, Ghadami A, Giurgiu M, Heinz A, Kiefer F, Kliegl R, Lenz B, Marciniak MA, Meyer-Lindenberg A, Neubauer AB, Rapp M, Smolka MN, Strehle J, Spanagel R, Spitta G, Tost H, Walter H, Zech H, Reichert D, Reichert M. Real-time mechanism-based interventions for daily alcohol challenges: Protocol for ecological momentary assessment and intervention. Digit Health. 2025 Jan 22;11:20552076241311731. doi: 10.1177/20552076241311731. eCollection 2025 Jan-Dec.

  PMID: 39845518 BACKGROUND

• Simmonds-Buckley M, Kellett S, Waller G. Acceptability and Efficacy of Group Behavioral Activation for Depression Among Adults: A Meta-Analysis. Behav Ther. 2019 Sep;50(5):864-885. doi: 10.1016/j.beth.2019.01.003. Epub 2019 Jan 29.

  PMID: 31422844 BACKGROUND

• Timm I, Giurgiu M, Ebner-Priemer U, Reichert M. The Within-Subject Association of Physical Behavior and Affective Well-Being in Everyday Life: A Systematic Literature Review. Sports Med. 2024 Jun;54(6):1667-1705. doi: 10.1007/s40279-024-02016-1. Epub 2024 May 6.

  PMID: 38705972 BACKGROUND

• Tindall L, Mikocka-Walus A, McMillan D, Wright B, Hewitt C, Gascoyne S. Is behavioural activation effective in the treatment of depression in young people? A systematic review and meta-analysis. Psychol Psychother. 2017 Dec;90(4):770-796. doi: 10.1111/papt.12121. Epub 2017 Mar 16.

  PMID: 28299896 BACKGROUND

• Torous J, Lipschitz J, Ng M, Firth J. Dropout rates in clinical trials of smartphone apps for depressive symptoms: A systematic review and meta-analysis. J Affect Disord. 2020 Feb 15;263:413-419. doi: 10.1016/j.jad.2019.11.167. Epub 2019 Dec 3.

  PMID: 31969272 BACKGROUND

• Trull TJ, Ebner-Priemer U. Ambulatory assessment. Annu Rev Clin Psychol. 2013;9:151-76. doi: 10.1146/annurev-clinpsy-050212-185510. Epub 2012 Nov 13.

  PMID: 23157450 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Markus Reichert, Prof

  Department of Sport and Exercise Science University of Salzburg

  STUDY DIRECTOR

Central Study Contacts

Claudio R. Nigg, Prof

CONTACT

0041316844188; claudio.nigg@unibe.ch

Lea Nitzpon, M.Sc.

CONTACT

0041316845106; lea.nitzpon@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ambulatory Assessment, Within-Person-Encouragement-Design

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Embargo on collected data until the manuscripts on the main aims of the project are accepted for publication.
• Access Criteria: request form to PI (Prof. Markus Reichert)

Locations

CH (1)