The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.
The study is a maximum of 42-day randomized controlled trial (RCT) of Whole Body Hyperthermia (WBH) vs. Sham for subjects with depressive symptoms at the Depression Clinical Research Program (DCRP) at Massachusetts General Hospital (MGH). 60 subjects with Major Depressive Disorder (MDD), males and females, between the ages of 18 and 65 years will be recruited and undergo a screening visit prior to being randomized to receive a single treatment of WBH or sham. The primary endpoint will be measurement of Interleukin-6 (IL-6) and other inflammation associated proteins (cytokines and heat shock proteins) in the plasma at one hour, 24h and one-week post WBH. A further endpoint is treatment response defined by a decrease of 50% or more in the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR) score at 7 days post-intervention, 2 weeks post-intervention, and 4 weeks post-intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
Massachusetts General Hospital Depression Clinical & Research Program
Boston, Massachusetts, United States
RECRUITINGChanges in serum levels of Interleukin-6 from baseline to post-treatment
Changes in serum levels of Interleukin-6 from baseline to post-treatment, measured by immunoassay
Time frame: baseline (pre-intervention), one hour post-intervention, 24 hours post-intervention, one week post-intervention
Decreases in depressive severity, as measured by the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR)
The Inventory of Depressive Symptomatology is a valid and reliable 30-item measure that is designed to assess severity of depression. The questions focus on neurovegetative and other depressive symptoms experienced over the past seven days. Possible values range from 0 to 84, with lower scores indicating lower depressive severity. A decrease of 50% or more in the IDS-CR score is considered to be a positive response to treatment, while a final score of 11 or less is considered typical remission. Depressive severity will be measured at baseline and at three timepoints post-intervention using the IDS-CR.
Time frame: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Decreases in depressive severity, as measured by the Symptoms of Depression Questionnaire (SDQ)
The Symptoms of Depression Questionnaire (SDQ) assesses irritability, anger attacks, and anxiety symptoms together with the commonly considered symptoms of depression. Depressive severity will be measured at baseline and at four timepoints post-intervention using the SDQ. Possible values range from 44 to 264, with lower scores indicating lower depressive severity.
Time frame: baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention
Changes in mental and physical functioning, as measured by the Patient Rated Outcome Measure Information System, 29-Item (PROMIS-29)
The PROMIS-29 is a short form assessment containing four items from each of seven domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) plus one pain intensity question (0-10 numeric rating scale). Possible values range from 4 to 20, with lower scores indicating better functioning.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Changes in mood, as measured by the Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a self-report measure that is made up of two mood scales, one measuring positive affect and the other measuring negative affect. Number of items: 10-items measuring positive affect, 10-items measuring negative affect. Scoring is broken down into a positive affect score and a negative affect score; possible values range from 10 to 50, with higher positive scores indicating higher positive affect, and higher negative scores indicating higher negative affect.
Time frame: baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention
Changes to quality of life, as measured by the World Health Organization Wellbeing Index (WHO-5)
The World Health Organization-Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. Possible values range from 0 to 25, with lower scores indicating lower quality of life.
Time frame: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Changes to quality of life, as measured by the Quality of Life, Enjoyment, and Satisfaction Questionnaire
The Quality of Life Enjoyment and Satisfaction Questionnaire is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Possible values range from 14 to 70, with lower scores indicating lower quality of life.
Time frame: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Reduction in perceived stress, as measured by the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Possible values range from 0 to 40, with lower scores indicating lower levels of perceived stress.
Time frame: baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention
Decreases in depressive severity, as measured by the Hamilton Depression Rating Scale 6-Item Self-Report (HAMD-6)
The Hamilton Depression Rating scale (self-report, 6-item) is specific to the core depressive symptoms of depressed mood, guilt, work and activities, psychomotor retardation, psychic anxiety, and general somatic symptoms (energy and physical pain), and it is unidimensional. Possible values range from 0 to 22, with lower scores indicating lower levels of depressive severity.
Time frame: baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention