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Whole-Body Hyperthermia for Depression: Effective or Too Early to Tell?
Bret A. Moore, PsyD, ABP.
Board-Certified Clinical Psychologist, San Antonio, TXDr. Moore has disclosed that he has no relevant financial or other interests in any commercial companies pertaining to this educational activity.
Review of: Janssen CW, Lowry CA, Mehl MR, et al. Whole-body hyperthermia for the treatment of major depressive disorder: a randomized clinical trial. JAMA Psychiatry 2016;73(8):789-795:ahead of print.
Study type: Randomized double-blind sham-controlled trial
Saunas and hot tubs are pleasant and “therapeutic” for most of us, so it may be no surprise that scientists are trying to turn such experiences into psychiatric treatments. Whole-body hyperthermia (WBH) is a treatment that has long been used as an effective adjunct for treatment of certain kinds of cancers, and recently researchers have been testing it for depression. A previous open-label trial in 16 adults diagnosed with major depression (Hanusch et al, Am J Psychiatry 2013;170:802–804) revealed promising results, so the same group decided to subject it to a randomized controlled trial.
Patients in Tuscon, Arizona were recruited via advertisements; inclusion criteria required a diagnosis of at least moderate major depression as measured by the Hamilton Depression Rating Scale (HDRS). Patients were not taking psychotropic medications. After dropouts, a total of 16 patients were randomly assigned to WBH, and 14 were assigned to sham. The WBH intervention consisted of lying on a gurney covered by a fabric-lined box, with the face exposed. Inside the box, heat was delivered to the chest via infrared lights and to the legs by heating coils. The session length was based on time required to reach a core body temperature of 38.5oC/101.3oF; on average, this took 107 minutes. Only one session was given. For the sham condition, the box looked the same, but with orange-colored non-heating lights and slight heat applied to the legs. The primary outcome was reduction in the HDRS 17-item at weeks 1, 2, 4, and 6.
Results
WBH was associated with significantly greater improvement in depression scores than sham. Baseline HDRS scores for WBH and sham dropped from 20.71 and 22.75, respectively, to 12.40 and 17.21 at week 6. There were no significant differences in adverse effects between groups, with headache, fatigue, and dry mouth being the most common. In order to assess how convincing the sham condition was, the investigators asked all patients whether they thought they had received the active treatment, and the majority of both groups said they had: 94% (15/16) of the WBH group and 71% (10/14) of the sham group.
TCPR’s Take
This is the first RCT that shows WBH outperforms a credible sham condition. The response was fast, and it was sustained for at least 6 weeks. Limitations of the study included the small sample size and the fact that patients were recruited via advertisements rather than being referred by clinics. Such patients might be less ill than depressed patients you’re likely to see in your practice. Surprisingly, the researchers did a pretty good job of creating a sham WBH condition, so the blinding may have worked fairly well—always a potential concern in studies of devices in psychiatry.
Practice implications
It’s still too early to tell if this WBH system is an effective antidepressant—we’d need to see this study replicated with a larger sample size. Nonetheless, if your patients have access to a sauna, these results might encourage you to recommend spending some time there as an kind of adjunct for antidepressant treatment.
General PsychiatryStudy type: Randomized double-blind sham-controlled trial
Saunas and hot tubs are pleasant and “therapeutic” for most of us, so it may be no surprise that scientists are trying to turn such experiences into psychiatric treatments. Whole-body hyperthermia (WBH) is a treatment that has long been used as an effective adjunct for treatment of certain kinds of cancers, and recently researchers have been testing it for depression. A previous open-label trial in 16 adults diagnosed with major depression (Hanusch et al, Am J Psychiatry 2013;170:802–804) revealed promising results, so the same group decided to subject it to a randomized controlled trial.
Patients in Tuscon, Arizona were recruited via advertisements; inclusion criteria required a diagnosis of at least moderate major depression as measured by the Hamilton Depression Rating Scale (HDRS). Patients were not taking psychotropic medications. After dropouts, a total of 16 patients were randomly assigned to WBH, and 14 were assigned to sham. The WBH intervention consisted of lying on a gurney covered by a fabric-lined box, with the face exposed. Inside the box, heat was delivered to the chest via infrared lights and to the legs by heating coils. The session length was based on time required to reach a core body temperature of 38.5oC/101.3oF; on average, this took 107 minutes. Only one session was given. For the sham condition, the box looked the same, but with orange-colored non-heating lights and slight heat applied to the legs. The primary outcome was reduction in the HDRS 17-item at weeks 1, 2, 4, and 6.
Results
WBH was associated with significantly greater improvement in depression scores than sham. Baseline HDRS scores for WBH and sham dropped from 20.71 and 22.75, respectively, to 12.40 and 17.21 at week 6. There were no significant differences in adverse effects between groups, with headache, fatigue, and dry mouth being the most common. In order to assess how convincing the sham condition was, the investigators asked all patients whether they thought they had received the active treatment, and the majority of both groups said they had: 94% (15/16) of the WBH group and 71% (10/14) of the sham group.
TCPR’s Take
This is the first RCT that shows WBH outperforms a credible sham condition. The response was fast, and it was sustained for at least 6 weeks. Limitations of the study included the small sample size and the fact that patients were recruited via advertisements rather than being referred by clinics. Such patients might be less ill than depressed patients you’re likely to see in your practice. Surprisingly, the researchers did a pretty good job of creating a sham WBH condition, so the blinding may have worked fairly well—always a potential concern in studies of devices in psychiatry.
Practice implications
It’s still too early to tell if this WBH system is an effective antidepressant—we’d need to see this study replicated with a larger sample size. Nonetheless, if your patients have access to a sauna, these results might encourage you to recommend spending some time there as an kind of adjunct for antidepressant treatment.
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