Heat and Mental Health - PART 2
Heat Effects on Mental Health in Young Adults (HEAT-MIND Lab PART 2)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 25 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks
- Procedures mentioned: Pills, Wearing a device, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will take part for about four weeks."
- "Participants will answer questions and do short thinking tasks, then go back to sleep. * Wear sensors that track their sleep, heart rate, and body temperature, and swallow a small capsule that measures body temperature from the inside * Answer questions about their mood and do short thinking tasks, both in the lab and at home * Use a phone app for the whole four weeks of the study."
- "Ecological momentary assessment and wearable monitoring run continuously across this entire period, including during both laboratory weekends, using the HEAT-MIND mobile application (Avicenna Research) in combination with wearable sensors."
- "Core body temperature is measured using an ingestible telemetric capsule (e-Celsius), peripheral temperature by iButton sensors (6 locations), and ambient temperature and humidity by fixed and portable environmental monitors (Kestrel Drop and SwitchBot IP65)."
- "Continuous heart rate is collected in parallel and additionally serves as a validated surrogate for core temperature, providing continuity in the event of capsule failure or early voiding and permitting internal cross-validation between measured and estimated core temperature within the sample."
- "Behavioral and affective assessment during laboratory weekends includes a semi-structured qualitative interview conducted by a research assistant on the final morning."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The goal of this clinical trial is to learn how hot indoor temperatures affect mood in young adults with depression, with or without anxiety. It will also explore whether the time of day the heat happens matters, and whether changes in sleep, thinking, and daily activity help explain the effect. The main questions it aims to answer are: * Does heat during the day affect mood differently than heat at night? * Do changes in sleep, thinking, or activity help explain those effects? Researchers will compare a weekend that is hot during the day to a weekend that is hot at night to see how the timing of heat affects mood. Participants will take part for about four weeks. During that time, participants will: * Stay in a sleep lab for two weekends, two weeks apart. Each stay runs from Friday afternoon to Monday midday. * Spend one weekend in rooms that are hot (32°C, or 90°F) from 8 in the morning to 8 at night, and comfortable (22°C, or 72°F) overnight * Spend the other weekend in rooms that are comfortable (22°C, or 72°F) during the day and hot (32°C, or 90°F) overnight * Be woken up at 2 in the morning on the last night of each lab stay. Participants will answer questions and do short thinking tasks, then go back to sleep. * Wear sensors that track their sleep, heart rate, and body temperature, and swallow a small capsule that measures body temperature from the inside * Answer questions about their mood and do short thinking tasks, both in the lab and at home * Use a phone app for the whole four weeks of the study. The app asks about mood and sleep, and works with the sensors to track sleep, movement, heart rate, temperature, and humidity.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * 18 ≥ age ≤ 25 at time of consent * has current depression as measured by a PHQ-9 score \>9 and corroborated by the DIAMOND Diagnostic Interview * resides within 75 mi. of Yale Biobehavioral Laboratory * willing/able to travel up to 75 mi. each way by car from their home to the Yale Biobehavioral Laboratory and back to their home * speaks/reads English fluently (surveys, interviews, and study measures are only validated in English; translating materials without proper validation could lead to responses that are not truly comparable, threatening reliability; limitations in budget, staffing, and available interpreters prevent the use of translated materials or hiring sufficient bilingual team members) * any gender * any race/ethnicity * able (have capacity)/willing to sign informed consent form (ICF) * has reliable access to a smartphone Exclusion Criteria: * age \<18 or age ≥26 at time of consent * does not have current depression as indicated by a PHQ-9 score \<9 * does not reside within 75 mi. of Yale Biobehavioral Laboratory * not willing/able to travel up to 75 mi. each way by car from their home to the Yale Biobehavioral Laboratory and back to their home * does not speak/read English fluently * unable (not have capacity)/unwilling to sign informed consent form (ICF) * has a job that requires rotating shifts and/or works 2nd or 3rd shift (i.e., night shifts) that affect circadian rhythm and sleep architecture * planned air travel between time zones during the study period that is likely to affect circadian rhythm * does not have reliable access to a smartphone * is pregnant or lactating * has a recent history (hospital admission within 2 years) of heat-related illness (e.g. heat stroke, heat exhaustion, or rhabdomyolysis) * weight \< 40 kg (88 lbs) - minimum body weight requirement * has a motility disorder of the gastrointestinal tract * has undergone surgical procedures in the gastrointestinal tract * has known swallowing disorders or dysphagia * has any condition that affects normal digestive function (GERD requiring treatment; Barrett's esophagus; achalasia or esophageal stricture; gastroparesis; IBS; inflammatory bowel disease (Crohn's disease or ulcerative colitis); celiac disease; microscopic colitis; chronic constipation or chronic diarrhea; malabsorption syndromes (e.g., pancreatic insufficiency, bile acid malabsorption); chronic liver disease; chronic pancreatitis; symptomatic gallbladder or post-cholecystectomy syndrome; prior bariatric surgery or bowel resection with ongoing effects; ostomy; chronic motility disorders; diabetes with autonomic neuropathy; neurologic or systemic diseases affecting GI function (e.g., Parkinson's disease, multiple sclerosis, scleroderma); chronic medication-induced GI dysfunction; eating disorders affecting digestion or nutrition. * has any condition that affects the body's ability to regulate temperature, including, Neurological conditions (such as spinal cord injuries, multiple sclerosis, traumatic brain injury, Guillain-Barré syndrome); Endocrine/metabolic disorders (such as hyperthyroidism/hypothyroidism, Type 1 or 2 diabetes, and anorexia nervosa); Cardiovascular conditions (such as Reynaud's disease, hypertrophic cardiomyopathy, and congenital heart); Dermatological conditions, (such as anhidrosis or hyperhidrosis and extensive burns or scarring associated with trauma). * engage in regular alcohol use (\>2 drinks per day), daily cannabis use, or any illicit drug use which can affect sleep architecture
Study sites (1)
CT
- Yale Biobehavioral and Translational Research Center · Orange, CT 06477Monica Ordway, PhD, APRN, PPCNP-BC, FAAN · Study contact · 203-737-5354 · monica.ordway@yale.eduSarah Linsky · Study contact · sarah.linsky@yale.eduKlar Yaggi, MD, MPH · Principal investigatorMonica Ordway, PhD, APRN, PPCNP, FAAN · Sub-investigatorMore trials in Orange