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CBT + Hyperthermia for Depression (HEATBED2 Trial)

N/A
Recruiting
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
Awards & highlights

Summary

This trial examines if 8 weekly CBT + 4 bi-weekly active WBH sessions can help reduce MDD symptoms in adults 18+.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Net Promoter Score
Secondary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
670,352 Total Patients Enrolled
61 Trials studying Depression
32,885 Patients Enrolled for Depression
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,602 Total Patients Enrolled
71 Trials studying Depression
26,303 Patients Enrolled for Depression
Frederick M Hecht, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT05708976 — N/A
Depression Research Study Groups: Sham Whole-body Hyperthermia (Sham Treatment), Active Whole-body Hyperthermia (Active Treatment)
Depression Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT05708976 — N/A
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708976 — N/A
~3 spots leftby Sep 2024