Nature-Based Exercise for Major Depressive Disorder
NCT07931443, Not applicable, Not yet recruiting, University of the Basque Country (UPV/EHU)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Nature-Based Exercise for Major Depressive Disorder | ClinicalTrials.gov |
| NCT number | NCT07931443 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 206 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of the Basque Country (UPV/EHU) | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder (MDD) | ClinicalTrials.gov |
| Interventions | Nature-Based Combined Exercise Program, Indoor Combined Exercise Program, Usual Mental Healthcare and Occupational Activities | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Depressive Symptom Severity Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline and 12 weeks (post-intervention) | Depressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-rated instrument consisting of 10 items evaluating depressive symptoms. Each item is scored from 0 to 6, resulting in a total score ranging from 0 to 60, with higher scores indicating greater depressive symptom severity. The outcome will be the change in total MADRS score from baseline to 12 weeks. Between-group differences will be evaluated using analysis of covariance, with the post-intervention MADRS score as the dependent variable, randomized group as the factor, and baseline MADRS score as a covariate. | ClinicalTrials.gov |
| Secondary | Clinical Response Rate Based on MADRS | 12 weeks (post-intervention; compared with baseline MADRS score where applicable) | Percentage of participants achieving a reduction of at least 50% in total MADRS score from baseline to 12 weeks. A higher percentage indicates a greater clinical response rate. | ClinicalTrials.gov |
| Secondary | Remission Rate Based on MADRS | 12 weeks (post-intervention; compared with baseline MADRS score where applicable) | Percentage of participants meeting the prespecified remission criterion on the MADRS at 12 weeks. The numerical remission threshold will be established according to the approved study protocol. | ClinicalTrials.gov |
| Secondary | Change in Functional Disability (Sheehan Disability Scale) | Baseline and 12 weeks (post-intervention) | Functional disability will be assessed using the Sheehan Disability Scale (SDS). The scale evaluates impairment in work or studies, social life, and family life. Each domain is scored from 0 to 10, giving a total score from 0 to 30. Higher scores indicate greater functional impairment. | ClinicalTrials.gov |
| Secondary | Change in Clinical Global Impression Severity (CGI-S) | Baseline and 12 weeks (post-intervention) | Overall psychiatric illness severity will be assessed using the Clinical Global Impression-Severity scale (CGI-S), a clinician-rated measure ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater illness severity. | ClinicalTrials.gov |
| Secondary | Change in Health-Related Quality of Life (SF-36) | Baseline and 12 weeks (post-intervention) | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), covering eight dimensions of physical and mental health. Scores will be calculated according to the instrument's standard scoring procedures, with higher scores indicating better health-related quality of life. | ClinicalTrials.gov |
| Secondary | Change in Mental Well-Being (WEMWBS) | Baseline and 12 weeks (post-intervention) | Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The instrument contains 14 positively worded items scored from 1 to 5, giving a total score from 14 to 70. Higher scores indicate greater mental well-being. | ClinicalTrials.gov |
| Secondary | Change in Peak Oxygen Uptake (VO2peak) | Baseline and 12 weeks (post-intervention) | Peak oxygen uptake will be measured during a maximal cardiopulmonary exercise test (CPET) performed on a treadmill using a modified Bruce protocol. VO2peak will be expressed in mL/kg/min. Higher values indicate better cardiorespiratory fitness. | ClinicalTrials.gov |
| Secondary | Change in Modified Shuttle Walk Test Performance | Baseline and 12 weeks (post-intervention) | Functional exercise capacity will be assessed using the Modified Shuttle Walk Test (MSWT), performed over a 10-meter course. Performance will be expressed as total distance covered in meters. Higher values indicate better functional exercise capacity. | ClinicalTrials.gov |
| Secondary | Change in Estimated Lower-Body Maximal Strength | Baseline and 12 weeks (post-intervention) | Lower-body maximal strength will be assessed using a submaximal velocity-based training protocol to estimate one-repetition maximum (1RM) in the squat and leg press exercises. Estimated 1RM will be expressed in kilograms. Higher values indicate greater maximal strength. | ClinicalTrials.gov |
| Secondary | Change in Estimated Upper-Body Maximal Strength | Baseline and 12 weeks (post-intervention) | Upper-body maximal strength will be assessed using a submaximal velocity-based training protocol to estimate one-repetition maximum (1RM) in the bench press exercise. Estimated 1RM will be expressed in kilograms. Higher values indicate greater maximal strength. | ClinicalTrials.gov |
| Secondary | Change in Handgrip Strength | Baseline and 12 weeks (post-intervention) | Isometric handgrip strength will be measured using a hand dynamometer. Three trials will be performed with each hand, and the highest recorded value will be used. Strength will be expressed in kilograms. Higher values indicate greater handgrip strength. | ClinicalTrials.gov |
| Secondary | Change in Objectively Measured Moderate-to-Vigorous Physical Activity | Baseline and 12 weeks (post-intervention; 8-day monitoring period at each assessment) | Moderate-to-vigorous physical activity will be assessed using an ActiGraph GT3X+ triaxial accelerometer worn on the non-dominant wrist over eight consecutive days. Physical activity will be quantified using the prespecified accelerometer processing procedures and expressed in minutes per day. | ClinicalTrials.gov |
| Secondary | Change in Objectively Measured Sedentary Time | Baseline and 12 weeks (post-intervention; 8-day monitoring period at each assessment) | Sedentary behavior will be assessed using an ActiGraph GT3X+ triaxial accelerometer worn on the non-dominant wrist over eight consecutive days. Sedentary time will be expressed in minutes per day according to the prespecified data processing criteria. | ClinicalTrials.gov |
| Secondary | Change in Self-Reported Physical Activity (IPAQ) | Baseline and 12 weeks (post-intervention; 8-day monitoring period at each assessment) | Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Physical activity will be quantified according to the questionnaire's scoring procedures and expressed in metabolic equivalent minutes per week (MET-min/week). Higher values indicate greater reported physical activity. | ClinicalTrials.gov |
| Secondary | Change in Accelerometer-Derived Sleep Duration | Baseline and 12 weeks (post-intervention; 8-day monitoring period at each assessment) | Sleep duration will be estimated from wrist-worn ActiGraph GT3X+ accelerometry over eight consecutive days using prespecified sleep identification and processing procedures. Mean sleep duration will be expressed in minutes per night. | ClinicalTrials.gov |
| Secondary | Change in Body Mass | Baseline and 12 weeks (post-intervention) | Body mass will be measured using a calibrated scale and expressed in kilograms. | ClinicalTrials.gov |
| Secondary | Change in Body Fat Percentage | Baseline and 12 weeks (post-intervention) | Body fat percentage will be estimated using bioelectrical impedance analysis. Results will be expressed as a percentage of total body mass. | ClinicalTrials.gov |
| Secondary | Change in Fat-Free Mass | Baseline and 12 weeks (post-intervention) | Fat-free mass will be estimated using bioelectrical impedance analysis and expressed in kilograms. | ClinicalTrials.gov |
| Secondary | Change in Waist Circumference | Baseline and 12 weeks (post-intervention) | Waist circumference will be measured using a flexible anthropometric measuring tape and expressed in centimeters. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)