HypErthermia as an Additional Treatment for the Biology and Experience of Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT); Device: Whole-Body Hyperthermia (WBH)

• Registration Number: NCT05041361
• Lead Sponsor: University of California, San Francisco

Brief Summary

This single-arm feasibility trial administered up to 8 weekly (early phase) or 4 bi-weekly (later phase) whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions to adults aged 18 years or older with major depressive disorder (MDD).

Detailed Description

Major Depressive Disorder afflicts more than 300 million people worldwide and is the leading cause of life years lost to disability. Current treatments have important limitations in efficacy and, in the case of medication, substantial side-effects. There is thus a compelling need for additional effective, well-tolerated treatments. One such potential treatment is whole-body hyperthermia (WBH). The investigators hypothesize that WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression. This work holds important promise to improve treatment of depression and advance understanding of the role of integrated mind-body therapies for mood disorders.

This single-arm feasibility trial piloted and optimized procedures for integrating WBH (initially 8 weekly sessions). During the course of this feasibility trial, with oversight and permission from the Sponsor, the 8 weekly WBH sessions were reduced to 4 bi-weekly WBH sessions to improve feasibility.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-13
• Study Start: 2021-10-11
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Results First Submitted: 2024-03-01
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Results First Posted: 2024-06-12
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH)	Cognitive Behavioral Therapy (CBT)	Participants receive up to 8 weekly (early phase) or 4 bi-weekly (later phase) whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions. Each WBH session (including preparation and cool down) is up to approximately 3.5-4 hours, and each CBT session is approximately 50 minutes.
Cognitive Behavioral Therapy (CBT) and Whole-Body Hyperthermia (WBH)	Whole-Body Hyperthermia (WBH)	Participants receive up to 8 weekly (early phase) or 4 bi-weekly (later phase) whole-body hyperthermia (WBH) sessions and 8 weekly cognitive behavioral therapy (CBT) sessions. Each WBH session (including preparation and cool down) is up to approximately 3.5-4 hours, and each CBT session is approximately 50 minutes.

Primary Outcome Measures

Name	Time	Method
Average Number of Planned WBH Sessions Completed	12 weeks	Investigators will average and report the number of completed WBH sessions (4 bi-weekly WBH sessions or 8 weekly WBH sessions offered to participants).

Secondary Outcome Measures

Name	Time	Method
Average Number of Planned Beck Depression Inventory-II (BDI-II) Assessments Completed	12 weeks	Investigators will average and report the number of completed BDI-II assessments (10 planned per participant)
Change in Beck Depression Inventory-II (BDI-II) From Baseline to 12-week Assessment	Baseline and 12 weeks	Change in BDI-II from baseline assessment to final assessment. BDI-II scores range from 0 to 63 with higher scores indicating more severe depression symptoms.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States