Heat and Mood in Young Adults with Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines how heat exposure in a controlled sleep-lab setting impacts mood, sleep, cognition, and activity in young adults with depression. Participants experience two weekends in a 32°C (90°F) hot condition and a 22°C (72°F) thermoneutral condition, with sessions scheduled Friday afternoon to Monday midday. The design compares daytime versus nighttime heat exposure to understand timing effects on mood and related factors, such as anger, aggression, and social behavior. The study explores potential pathways including sleep disruption, cognitive performance, and physical activity as mediators of heat-related mood changes. It is conducted alongside an observational study within the same HEAT-MIND Lab program at Yale, with Hartford Hospital as lead sponsor and Yale University and University of Oxford as collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale Biobehavioral and Translational Research Center
  Orange, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Joshua R Wortzel, MD, MPhil, MS(Ed) — Hartford HealthCare
• Study coordinator: Isaac C McAlister, PhD
• Email: Isaac.McAlister@hhchealth.org
• Phone: 860-545-7231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.