Depression - Major Depressive Disorder, Menopausal Depression
Conditions
Keywords
postmenopausal women, major depressive disorder, adapted physical activity
Brief summary
APhyDeM is a randomized controlled study investigating the relationship between adapted physical activity and mitochondrial function in postmenopausal women with major depressive disorder. Depression is associated with metabolic dysfunction, including alterations in mitochondrial activity and inflammatory processes. Physical activity has been shown to influence mitochondrial function, yet individuals with depression frequently experience reduced physical activity levels. This study aims to evaluate whether an adapted physical activity program can improve mitochondrial function compared with a control intervention. Mitochondrial function will be indirectly assessed using near-infrared spectroscopy to measure post-exercise muscle oxygen recovery kinetics. The study compares adapted physical activity with a non-physical therapeutic intervention in postmenopausal women receiving care in a psychiatric day hospital setting.
Interventions
OTHERAPA
3 sessions/week of APA (1h yoga, 1h dance, 1h muscle strengthening)
OTHERCCATTP
2 sessions/week of 2 hours art therapy. This approach is already used in routine healthcare and is not a procedure specific to the study.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Menopaused women aged ≥ 40 years old, * Suffering from a major depressive episode according to international Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) * Presenting a score ≥11 on the 16-item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) depression scale * With a stabilized teatment by antidepressors since at least 4 weeks
Exclusion criteria
* Medical contraindication for physical activity (cardio-vascular pathology, and/or previous cardiac disease) * Asthma or other unstabilized condition impairing the ability to perform physical exertion * Adipose tissue thickness measured on the forearm \> 12 mm causing muscle oxygenation measurement by NIRS to be non contributive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| K recovery constant | Week 8 | Relative difference of K recovery constant (min-1) reflecting the recovery speed of muscular oxygenation, assessed with muscular near-infrared spectroscopy (NIRS) at week 8, comparing with pre-randomization value. This measure is assessed at rest and following mitochondrial activation by MOTOmed15 movement therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics. | Baseline, Week 8 (end of intervention), and Week 12 (4 weeks post-intervention). | The recovery rate constant k will be assessed using near-infrared spectroscopy (NIRS). Measurements will be performed at rest and following mitochondrial activation induced by standardized exercise using a MOTOMed device. |
| Relative change in recovery rate constant k (min-¹) reflecting post-exercise muscle oxygen reoxygenation kinetics. | Week 8 (end of intervention) and Week 12 (4 weeks post-intervention) | The relative change in k will be calculated from baseline (pre-randomization) to post-intervention time points using near-infrared spectroscopy (NIRS). Measurements will be performed at rest and following mitochondrial activation with the MOTOMed device. |
| Depressive symptomatology | Baseline, Week 8, and Week 12 | Depression will be assessed using the Quick Inventory of Depressive Symptomatology - Clinician Rated, 16-item version (QIDS-C16) and Self-Report, 16-item version (QIDS-SR16). Measurements will be compared to baseline in both study arms. |
| Fatigue | Baseline, Week 8, and Week 12 | Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue). Measurements will be compared to baseline in both study arms. |
| Suicidal ideation | Baseline, Week 8, and Week 12 | Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation (SSI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). Measurements will be compared to baseline in both study arms. |
| Physical performance | Baseline, Week 8, and Week 12 | Physical performance will be assessed using the following tests: bilateral handgrip strength with a dynamometer, the 30-second chair stand test, and the 6-minute walk test. Measurements will be compared to baseline in both study arms. |
| Motivation for physical activity | Baseline, Week 8, and Week 12 | Motivation will be assessed using the Behavioral Regulation in Exercise Questionnaire - 2, short version (BREQ-2). Measurements will be compared to baseline in both study arms. |
| Physical activity level | Baseline, Week 8, and Week 12 | Physical activity will be assessed using a self-reported weekly activity questionnaire and a participant activity logbook. Measurements will be compared to baseline in both study arms. |
| Physical and emotional pain | Baseline, Week 8, and Week 12 | Pain will be assessed using the Visual Analog Scale for Physical and Emotional Pain (PPP-VAS2). Measurements will be compared to baseline in both study arms. |
| Motivation | Baseline, Week 8, and Week 12 | Motivation will be assessed using the Effort Expenditure for Rewards Task (EEfRT) computerized test coupled with a cycle ergometer. Measurements will be compared to baseline in both study arms. |
| Anhedonia | Baseline, Week 8, and Week 12 | Anhedonia will be assessed using the Snaith-Hamilton Pleasure Scale (SHAPS). Measurements will be compared to baseline in both study arms. |
| Psychomotor slowing | Baseline, Week 8, and Week 12 | Psychomotor slowing will be assessed using the Échelle de Ralentissement Dépressif (ERD). Measurements will be compared to baseline in both study arms. |
| Health-related quality of life (SF-36 total score) | Baseline, Week 8, and Week 12 | Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Measurements will be compared to baseline in both study arms. |
| Inflammatory profile | Baseline, Week 8, and Week 12 | Inflammatory status will be assessed using C-reactive protein (CRP) measurements performed as part of routine clinical care. Measurements will be compared to baseline in both study arms. |
Countries
France
Contacts
CONTACTKarine CHARRIERE, PhD
PRINCIPAL_INVESTIGATORDjamila BENNABI, MD PhD
CHU de Besançon
Outcome results
None listed