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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

HEATBED2 Trial 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.

HEATBED2 Trial 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

HEATBED2 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

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,943 Total Patients Enrolled
61 Trials studying Depression
32,880 Patients Enrolled for Depression
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,525 Total Patients Enrolled
71 Trials studying Depression
28,798 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: Active Whole-body Hyperthermia (Active Treatment), Sham Whole-body Hyperthermia (Sham 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research program still being accepted?

"According to the details on clinicaltrials.gov, this particular trial has stopped recruiting participants since January 23rd 2023. Nevertheless, there are currently 1,379 other trials that have active recruitment open for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Looking for ways to manage my depression in addition to traditional antidepressants which have not been effective for me.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2
2023. "HypErthermia as an Additional Treatment for the Biology and Experience of Depression: Study 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708976.
All > Hyperthermia
~4 spots leftby Jun 2024
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