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Depressive Disorder, MajorMASENCT07059234

The Motor Activity - Subjective Energy (MASE) Project

A study testing Non-exercise activity in people with Depressive Disorder, Major, run by University of Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Non-exercise activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteSwitzerland
Study dates
2 Sep 2025to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudio R. Nigg, Prof contact

0041316844188

claudio.nigg@unibe.ch

Lea Nitzpon, M.Sc. contact

0041316845106

lea.nitzpon@unibe.ch

Switzerland1 site, 1 recruiting
  • University of Bern

    Bern, 3012

    Claudio R. Nigg, Prof. Dr., +41 31 684 41 88, claudio.nigg@unibe.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Non-exercise activity
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-exercise activityBehavioural

    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.

Study groups in NCT07059234
Study groupRoleWhat they receive
A, 50%ExperimentalThe 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
Receives: Behavioral: Non-exercise activity
B, 75%ExperimentalThe 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
Receives: Behavioral: Non-exercise activity
C, 25%ExperimentalIntervention 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
Receives: Behavioral: Non-exercise activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: pre-post intervention (at 5 weeks)

Secondary outcomes (1)
  1. Change / stability in depressive symptoms in acute / remitted MDD patients

    Depression severity will be evaluated using the MADRS on a 7-point Likert-scale (with higher scores indicating more depressive symptoms)

    Measured: pre-post intervention (at 5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start2 Sep 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Ambulatory Assessment, Within-Person-Encouragement-Design
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07059234
Sponsor's protocol ID
2025-00691
Other IDs
2025
Acronym
MASE
Status last verified
Sep 2025
First submitted
1 Jul 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: To facilitate data sharing, the investigators (Is) will include a standardized data request form and contact information for data requests in the MASE OSF folder. Pseudonymized processed data will be suitable for sharing with research organizations that will comply with the research project's data protection policy, GDPR and relevant ethical principles. In accordance with these policies, the Is will create a standardized data sharing agreement to be used by research organizations who wish to use the data for research purposes. The legal and ethical grounds for data sharing of pseudonymized data is consent of the participant. Raw location data will never be shared externally and will never leave UB and RUB. When sharing data, the Is will include a detailed codebook on all variables, defining their type, scale, content, and if applicable their calculation. The codebook will also contain information on the methodology of data collection and on all data preprocessing steps.

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 Nov.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 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, 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.

    PubMed 31859437
  • 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.

    PubMed 23641221
  • 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.

    PubMed 39845518
  • 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.

    PubMed 31422844
  • 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.

    PubMed 38705972
  • 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.

    PubMed 28299896
  • 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.

    PubMed 31969272
  • 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.

    PubMed 23157450

Questions about this trial

What is this clinical trial studying?

A study testing Non-exercise activity in people with Depressive Disorder, Major, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudio R. Nigg, Prof (0041316844188, claudio.nigg@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of real-life physical activity-subjective energy association (time frame: pre-post intervention (at 5 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07059234, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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