What side effects are associated with this type of intervention?

Common treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), often have side effects. These can include nausea, headache, sleep disturbances (insomnia or drowsiness), sexual dysfunction, dry mouth, dizziness, and weight gain. Some patients may also experience increased anxiety or agitation, especially when starting the medication. It is important to monitor these side effects and discuss them with a healthcare provider to manage and adjust treatment as necessary.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and escitalopram, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine and duloxetine. These medications are often used due to their efficacy and tolerability. Additionally, cognitive behavioral therapy (CBT) is a well-established non-pharmacologic treatment for depression. The trial involving Active Whole-Body Hyperthermia (WBH) explores an innovative approach by combining WBH with CBT to modulate thermoregulatory and neuroendocrine systems, potentially offering a novel adjunctive treatment for major depressive disorder.

What other types of research exist?

Promising novel alternatives to Active Whole-Body Hyperthermia for depression treatment in 2024 include: 1) Cognitive Behavioral Therapy (CBT), particularly when combined with other modalities such as telephone-based CBT for insomnia; 2) Mind-body therapies like guided imagery, hypnosis, and biofeedback, which have shown efficacy in treating various conditions including depression; 3) Pharmacological options such as SSRIs and SNRIs, which are well-established but continue to evolve with new formulations and combinations; 4) Complementary therapies like mindfulness training and relaxation techniques, which have demonstrated benefits in clinical trials. These alternatives offer diverse approaches to managing depression, targeting both psychological and physiological aspects of the condition.

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CBT + Hyperthermia for Depression (HEATBED2 Trial)

N/A

Waitlist Available

Led By Frederick M Hecht, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks

Summary

This trial uses talk therapy and body heating sessions to help adults with major depression. It aims to find better treatment options by combining these methods. Talk therapy changes negative thoughts and behaviors, while body heating might boost mood.

Who is the study for?

Adults over 18 with major depression for at least 2 weeks, scoring >21 on the Beck Depression Inventory-II. Participants must understand the study, consent in writing, have a smartphone for app use, and lie on their back for sauna sessions. Excluded if they can't fit in the sauna device, are pregnant or breastfeeding, attempted suicide recently or have certain suicidal thoughts, take medications affecting body temperature regulation or antidepressants (unless off them for 4 weeks), engage in heavy exercise before sessions or use nicotine regularly.

What is being tested?

The trial tests whether adding whole-body hyperthermia to cognitive behavioral therapy helps adults with major depressive disorder. It compares active hyperthermia treatments to sham (fake) ones alongside weekly CBT sessions. Participants are randomly assigned to receive either real or sham heat treatments bi-weekly.

What are the potential side effects?

Potential side effects of whole-body hyperthermia may include discomfort due to heat exposure such as sweating and dehydration; rare cases might involve overheating leading to more serious conditions like heat stroke. Cognitive Behavioral Therapy typically does not cause physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Net Promoter Score

Secondary study objectives

Change in Beck Depression Inventory-II (BDI-II)

Change in Hamilton Depression Rating Scale 6-item (HAMD-6) Self-Report

Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 4a Anxiety

+1 more

Other study objectives

Sudden gains in antidepressant responses

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Whole-body Hyperthermia (Active Treatment)Experimental Treatment2 Interventions

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions that raise core body temperature to 38.5 C. Each active WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Group II: Sham Whole-body Hyperthermia (Sham Treatment)Placebo Group2 Interventions

Participants receive 8 cognitive behavioral therapy (CBT) sessions and 4 bi-weekly sham whole-body hyperthermia (WBH) sessions, which minimally raise body temperature. Each sham WBH session (including preparation and post-session activities) is up to approximately 3.5 hours, and each CBT session is approximately 50 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy (CBT)

2008

Completed Phase 4

~3620

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include antidepressants, cognitive-behavioral therapy (CBT), and mindfulness-based cognitive therapy (MBCT). Antidepressants, such as SSRIs and SNRIs, work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which helps improve mood and emotional stability. CBT focuses on changing negative thought patterns and behaviors, while MBCT combines mindfulness practices with cognitive therapy to help patients become more aware of their thoughts and feelings and manage them without judgment. These treatments are crucial as they address both the biological and psychological aspects of depression, providing a comprehensive approach to managing the condition. Active Whole-Body Hyperthermia, which modulates thermoregulatory and neuroendocrine systems, may offer an alternative or complementary approach by potentially affecting similar neurobiological pathways involved in mood regulation.

NMDA receptor blockade at rest triggers rapid behavioural antidepressant responses.