CBT + Hyperthermia for Depression

Not yet recruiting at 2 trial locations
AE
SM
Overseen BySarah M Fisher, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cognitive behavioral therapy (CBT) and whole-body hyperthermia (WBH) can help treat major depressive disorder (MDD). Participants will receive various combinations of these treatments to determine the most effective approach. The trial suits individuals who have experienced depression symptoms for at least two weeks and can lie down in a sauna for a few hours at a time. It offers a chance to potentially benefit from new approaches to managing depression. As an unphased trial, it allows participants to contribute to innovative research and explore new treatment options for depression.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications before joining the trial. Participants must be free of antidepressant medications for at least 4 weeks and other specific medications like antibiotics, pain medication, and emergency contraception for 14 days before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that whole-body hyperthermia (WBH), which involves temporarily raising the body's temperature, is generally safe and well-tolerated. Participants often report improved mood after undergoing WBH. Few negative side effects have been reported, making it a promising option for treating depression.

Cognitive Behavioral Therapy (CBT) is another treatment under study. This well-known and effective form of talk therapy for depression is widely used and generally considered safe, with minimal risks. Although CBT may sometimes bring up uncomfortable emotions, this is a normal part of the therapy process.

When combined, WBH and CBT continue to show promise. Early research suggests that this approach is both practical and safe. Both treatments aim to reduce symptoms of depression and improve overall well-being.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for depression because they combine cognitive behavioral therapy (CBT) with whole-body hyperthermia (WBH) to explore new ways of relieving symptoms. Unlike standard antidepressants, which primarily target brain chemistry, WBH involves raising the body's core temperature, potentially impacting mood regulation through biological pathways not yet fully understood. By pairing CBT with WBH, there's a unique opportunity to enhance the therapeutic effects beyond what conventional therapy or medication alone might achieve. This novel combo could provide faster, more effective relief for individuals who haven't responded well to typical treatments like antidepressants or therapy alone.

What evidence suggests that this trial's treatments could be effective for major depressive disorder?

Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, effectively reduces depression symptoms. A review of 115 studies found that CBT helps many people with depression, often providing long-lasting benefits. In one study, 43% of participants reported their symptoms were cut in half over several months.

Whole-body hyperthermia (WBH), another treatment option in this trial, is a newer approach that looks promising. Studies suggest that just one session can quickly ease depression symptoms, with effects lasting up to six weeks. This treatment raises the body's core temperature, which seems to improve mood.

The trial will also explore combining CBT and WBH, which might enhance treatment effectiveness. Early research suggests that using both together could reduce depression symptoms more than using either treatment alone. However, more research is needed to confirm these benefits.678910

Who Is on the Research Team?

AE

Ashley E Mason, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who currently have major depression lasting at least two weeks, can read and speak English, are able to use the internet, and can lie down in a sauna device for up to 2 hours. Women of childbearing age must agree to use birth control.

Inclusion Criteria

Able to read and speak in English
Access to the internet via computer, smartphone, or tablet
I am 18 years old or older.
See 4 more

Exclusion Criteria

Unwillingness to refrain from marijuana and alcohol for 24 hours before and after WBH session
Comorbid psychiatric conditions that might better explain depressive symptoms including schizophrenia, schizoaffective disorder, Bipolar Disorder I, OCD, Anorexia Nervosa, Bulimia Nervosa, Alcohol or Drug Dependence
Known hypersensitivity to hyperthermia and/or infrared exposure
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weekly cognitive behavioral therapy (CBT) sessions and 4 bi-weekly whole-body hyperthermia (WBH) sessions

8 weeks
8 CBT visits (in-person), 4 WBH visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Post-intervention assessments

Long-term follow-up

Participants complete study assessments including weekly surveys and follow-up assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Therapy (CBT)
  • Whole-Body Hyperthermia

Trial Overview

The study tests if combining cognitive behavioral therapy (CBT) with whole-body hyperthermia (WBH), either alone or together, helps treat major depressive disorder. Participants are randomly assigned to receive CBT sessions, WBH sessions, both treatments, or neither.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: WBH and CBTExperimental Treatment2 Interventions
Group II: WBH OnlyExperimental Treatment1 Intervention
Group III: CBT OnlyExperimental Treatment1 Intervention
Group IV: No InterventionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+

Citations

Whole-Body Hyperthermia (WBH) and Cognitive Behavioral ...

In this single-arm trial, 16 adults with MDD initially received 8 weekly CBT sessions and 8 weekly WBH sessions. Outcomes included WBH sessions completed ( ...

Cognitive Behavioral Therapy (CBT) and Whole-Body ...

Study procedures were acceptable. Participants in the WBH and sham WBH groups had substantial reductions in depressive symptoms that were ...

Treating major depressive disorder with an integrated mind ...

This case report describes a patient's outcomes after completing an integrated mind-body depression intervention that combined cognitive-behavioral therapy (CBT) ...

Optimizing an integrated whole-body hyperthermia and ...

We hypothesize that WBH may be particularly effective in combination with cognitive behavioral therapy (CBT), an established treatment for depression.

Heat Therapy Shows Promise in the Treatment of ...

Receiving whole-body hyperthermia, a type of body heating treatment, in addition to cognitive-behavioral therapy (CBT) may lower depressive symptoms, suggests ...

The Efficacy of Cognitive Behavioral Therapy - PMC - NIH

The data supporting CBT for depression was less strong, but still in the medium effect size range across meta-analyses, with maintenance in 6-month follow ...

Cognitive Behavioral Therapy for Depression - PMC - NIH

A meta-analysis of 115 studies has shown that CBT is an effective treatment strategy for depression and combined treatment with pharmacotherapy is ...

Cognitive behavioral therapies are evidence-based – ...

CBTs currently hold status as research-supported or evidence-based treatments for depressive disorders (APA, 2021; NICE, 2022) and are suggested as first-line ...

Study finds CBT offers long-term benefits for people with ...

Over the course of 46 months, 43 per cent of those who had received CBT had improved, reporting at least a 50 per cent reduction in symptoms of ...

A systematic review of digital and face-to-face cognitive ...

Cognitive behavioral therapy (CBT) is the gold-standard intervention for major depression besides pharmacotherapy. Since its emergence nearly ...