Depression - Major Depressive Disorder
Conditions
Keywords
time-restricted eating, Mediterranean diet, nutritional intervention, feasibility
Brief summary
The goal of this clinical trial is to assess the feasibility of nutritional interventions in college students with depression. The main outcomes it aims to measure are: * Nutritional content, meal timing, and sleep patterns in college students with depression * Feasibility of nutritional interventions (Mediterranean Diet and Time-Restricted Eating + Mediterranean Diet) in college students with depression Researchers will compare two groups - Mediterranean Diet (Med-Diet) and Time-Restricted Eating + Mediterranean Diet (TRE + Med-Diet) - to assess adherence to the dietary interventions and overall feasibility of the study procedures. Participants will: * Complete a 2-week baseline logging diet, sleep, activity, and mood * Be randomized to Mediterranean Diet (Med-Diet) or Time-Restricted Eating + Med-Diet (TRE + Med-Diet) * Participate in dietary counseling with a registered dietitian during the 8-week intervention * Continue to log diet, wear an actigraphy device, and complete mood, sleep, and diet assessments throughout the intervention
Interventions
BEHAVIORALMediterranean Diet
Participants will receive ongoing dietary counseling, nutritional resources, and practical tips to support adoption of a Mediterranean-style dietary pattern emphasizing healthy fats (e.g., olive oil), whole grains, fruits, vegetables, and legumes, while limiting red meat and dairy products throughout the intervention period.
BEHAVIORALTime-Restricted Eating
Participants will receive guidance to restrict daily food intake to a consistent 10-hour eating window.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and enrolled as a college student * Symptoms of mild to moderate depression * Receiving treatment for depression or willing to receive treatment during study participation * Generally in good physical health * On a stable dose of any medication affecting weight, metabolism, or mental health
Exclusion criteria
* Elevated risk for suicide * Inability to participate safely, as determined by the study physician * Lifetime diagnosis of bipolar disorder, schizophrenia, or post-traumatic stress disorder * Current eating disorder (e.g., bulimia, anorexia nervosa, binge eating) * Current alcohol or substance use disorder * Shift work outside of class schedule in the past 30 days * Pregnancy or lactation * Treatment with an investigational drug for depression or participation in another study requiring modification of diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset | From enrollment to the end of baseline (2 weeks) | Actigraphy determined sleep onset time (h:m) |
| Sleep offset | From enrollment to the end of baseline (2 weeks) | Actigraphy determined sleep offset time (h:m) |
| Sleep Duration | From enrollment to the end of baseline (2 weeks) | Formula: sleep offset - sleep onset (h:m). A larger number indicates a longer sleep duration. |
| M10 | From enrollment to the end of baseline (2 weeks) | Average activity level from 10 hours of highest activity (counts/hour) |
| L5 | From enrollment to the end of baseline (2 weeks) | Average activity level from 5 hours of lowest activity (counts/hour) |
| Relative Amplitude | From enrollment to the end of baseline (2 weeks) | Formula: Relative Amplitude =(M10-L5)/(M10+L5). A value near 1 indicates a strong, well-defined circadian rhythm (high activity during the day and very low activity at night), and a value near 0 indicates a fragmented or "flat" rhythm (little difference between your most active and least active periods). |
| Interdaily Stability | From enrollment to the end of baseline (2 weeks) | The ratio of the variance of the average 24-hour activity profile to the variance of the overall 24-hour data. Actigraphy is collected over 2 weeks and averaged to create a single, representative 24-hour profile. Interdaily Stability values range from 0 to 1, where 0 indicates a total lack of stability and 1 indicates perfect stability. Lower values suggest fragmented, weak, or disrupted circadian rhythms. |
| Caloric intake timing | From enrollment to the end of baseline (2 weeks) | Time of calorie consumption (h:m) |
| MEQ Score | Baseline measure in week 2 | The Morningness-Eveningness Questionnaire (MEQ) is a 19-item self-report assessment used to determine an individual's circadian preference (chronotype), ranging from morning-type to evening-type. Scores range from 16 to 86, with higher scores indicating morningness and lower scores indicating eveningness. |
| PHQ9 Score | Baseline measure in week 2 | The PHQ-9 is a 9-item, self-report questionnaire used to screen for and measure the severity of depression in clinical trials. It covers the 9 diagnostic criteria for major depressive disorder based on the DSM-IV. Total scores range from 0 to 27, with higher scores indicating higher levels of depression. |
| PDQ-D5 Score | Baseline measure in week 2 | The PDQ-D5 is a self-report questionnaire assessing subjective cognitive impairment. It includes five items covering four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. The total score is the sum of the five items, ranging from 0 to 20. Higher scores indicate greater perceived cognitive deficits, while lower scores indicate fewer problems. |
| PSQI Score | Baseline measure in week 2 | The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality and disturbances over a one-month interval. It measures seven components (quality, latency, duration, efficiency, disturbances, medication, dysfunction) to produce a global score from 0 to 21, where higher scores indicate poorer sleep quality. |
| Recruitment Rate | From study initiation to end of recruitment period (approximately 16 months) | Formula: Total participants enrolled / enrollment time window, with higher numbers indicating better recruitment. |
| Retention Rate | From enrollment to study completion (approximately 19 months) | Formula: (number of participants that complete the study / number of participants that enrolled) x 100, reported as percentage with higher numbers indicating higher retention. |
| Missing Data Rate | From baseline to end of study visit (weeks 1-12) | The missing data rate is defined as the percentage of expected data points for primary outcomes (e.g., daily food logs, daily actigraphy wearing, and survey responses) that were not collected or were unusable at the final study visit. Calculation: (Number of missing data points / Total number of expected data points across all enrolled participants) × 100 reported as a percentage with higher values indicating more missing data. Note: This includes data missing due to participant withdrawal or non-response to specific survey items. |
| Change in Mediterranean Diet Adherence Screener (13-MEDAS) Score | Measured at baseline in week 2 and during intervention in week 10 | Adherence to the Mediterranean Diet is assessed using the validated 13-item Mediterranean Diet Adherence Screener (13-MEDAS). The questionnaire evaluates the consumption frequency of Mediterranean dietary staples (e.g., olive oil, vegetables, fruits, nuts, fish, legumes) and frequency of unhealthy food choices (e.g., animal fats, sugar-sweetened beverages). Each item is scored 0 or 1. The total score ranges from 0 to 13, with higher scores indicating greater adherence. |
| Time-restricted eating adherence | Measured throughout nutritional intervention (week 3-11) | Using the time of first and last caloric intake of the day, time-restricted eating adherence is calculated as the percentage of days where all food was consumed within the designated 10 h time window. |
| Mediterranean Diet Intervention Acceptability | End of study (week 10-12) | Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The Mediterranean diet changes were manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data for all participants reported. Higher values indicate diet content modifications were more manageable. |
| Time-Restricted Eating Intervention Acceptability | End of study (week 10-12) | Participant-reported manageability of diet changes on study team generated Intervention Acceptability Survey. A single item ("The time restriction on calorie intake was manageable") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Data reported for Group 2 only (Mediterranean Diet + Time-Restricted Eating). Higher values indicate diet timing modifications were more manageable. |
| Participant-Reported Global Impression of Change in Depression | End of study (week 10-12) | A single-item assessment of the overall change in depression since study entry. Scale: 1 = Very Much Worse, 2 = Much Worse, 3 = Minimally Worse, 4 = No Change, 5 = Minimally Improved, 6 = Much Improved, 7 = Very Much Improved. Higher scores indicate greater improvement. |
| Perceived Impact of Dietary Changes on Sleep | End of study (week 10-12) | A single item ("The dietary changes made during the study had a positive impact on my sleep") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact. |
| Perceived Impact of Dietary Changes on Metabolic Health | End of study (week 10-12) | A single item ("The dietary changes made during the study had a positive impact on my metabolic health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact. |
| Perceived Impact of Dietary Changes on Overall Health | End of study (week 10-12) | A single item ("The dietary changes made during the study had a positive impact on my overall health") will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a more positive perceived impact. |
| Participant-Reported Intent for Long-term Dietary Maintenance | End of study (week 10-12) | A single-item assessment of the participant's intention to continue the intervention diet after the study concludes ('I plan to maintain dietary changes from the study moving forward') will be scored on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate a higher intent to maintain the dietary changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Duration | Baseline (week 1-2) and intervention (week 9-11) | Sleep Duration = Sleep Offset - Sleep Onset (h:m). Change in Sleep Duration will be calculated with baseline (2 week period) and end of intervention (2 week period). |
| Change in Relative Amplitude | Baseline (week 1-2) and intervention (week 9-11) | Relative Amplitude =(M10-L5)/(M10+L5). A value near 1 indicates a strong, well-defined circadian rhythm (high activity during the day and very low activity at night), and a value near 0 indicates a fragmented or "flat" rhythm (little difference between your most active and least active periods). Change in Relative Amplitude will be calculated with baseline (2 week period) and end of intervention (2 week period). |
| Change in Interdaily Stability | Baseline (weeks 1-2) and intervention (weeks 9-11) | The ratio of the variance of the average 24-hour activity profile to the variance of the overall 24-hour data. Actigraphy is collected over 2 weeks and averaged to create a single, representative 24-hour profile. Interdaily Stability values range from 0 to 1, where 0 indicates a total lack of stability and 1 indicates perfect stability. Lower values suggest fragmented, weak, or disrupted circadian rhythms. Change in Interdaily Stability will be calculated with baseline (2 week period) and end of intervention (2 week period). |
| Change in PHQ9 | Baseline (week 2) and intervention (week 10) | The PHQ-9 is a 9-item, self-report questionnaire used to screen for and measure the severity of depression in clinical trials. It covers the 9 diagnostic criteria for major depressive disorder based on the DSM-IV. Total scores range from 0 to 27, with higher scores indicating higher levels of depression. Change in PHQ9 will be calculated with baseline (week 2) and end of intervention (week 10). |
| Change in PDQ-D5 Score | Baseline (week 2) and intervention (week 10) | The PDQ-D5 is a self-report questionnaire assessing subjective cognitive impairment. It includes five items covering four subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. The total score is the sum of the five items, ranging from 0 to 20. Higher scores indicate greater perceived cognitive deficits, while lower scores indicate fewer problems. Change in PDQ-D5 will be calculated with baseline (week 2) and end of intervention (week 10). |
| Change in PSQI Score | Baseline (week 2) and intervention (week 10) | The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality and disturbances over a one-month interval. It measures seven components (quality, latency, duration, efficiency, disturbances, medication, dysfunction) to produce a global score from 0 to 21, where higher scores indicate poorer sleep quality. Change in PSQI will be calculated with baseline (week 2) and end of intervention (week 10). |
Countries
United States
Contacts
CONTACTMichael J McCarthy
Outcome results
None listed