Self-Administered Hypnosis vs Sham Hypnosis for Hot Flashes: A Randomized Clinical Trial.

Importance: Many women experience significant adverse effects from menopausal hot flashes. Clinical hypnosis has been shown to be an effective and safe nonhormonal treatment for hot flashes, but there is a need to increase the accessibility of this intervention. Objectives: To evaluate the efficacy of a self-administered hypnosis intervention for hot flashes compared with a self-administered sham white noise hypnosis control, evaluate the efficacy of the intervention compared with sham hypnosis for hot flash activity interference and perception of benefit, and examine the interaction between practice adherence and treatment effect. Design, Setting, and Participants: This multicenter, 2-arm, single-blind, randomized clinical trial was conducted from March 4, 2019, to February 16, 2024. Participants were 250 postmenopausal women self-reporting a minimum of 4 daily or 28 weekly hot flashes at baseline who were recruited at Baylor University in Waco, Texas, and the University of Michigan in Ann Arbor. Intervention: Participants were randomized into either a 6-week self-administered hypnosis condition or a self-administered sham white noise condition. The hypnotic inductions consisted of cooling imagery and suggestions for relaxation, while the white noise condition was designed to be an active control accounting for all components present in the intervention arm, including placebo and cognitive expectancy effects, without the therapeutic components present in the active arm. Main Outcomes and Measures: The primary outcome was the change in hot flash score from baseline to 6 weeks, with a 12-week follow-up. The hot flash score (lower scores indicate less frequent and less severe hot flashes) was calculated as a product of the frequency and severity of hot flashes as reported in their daily hot flash diary. Secondary outcomes included hot flash activity interference, measured using the Hot Flash Related Daily Interference Scale (HFRDIS; score range, 0-100; lower scores indicate less interference from hot flashes on participants' daily activities, enjoyment, or quality of life), and perception of benefit, measured using the Subject Global Impression of Change. Analysis was conducted on an intent-to-treat basis. Results: Participants were 250 women (mean [SD] age, 55.9 [6.9] years) experiencing hot flashes, 62 (24.8%) of whom had a history of breast cancer. Overall improvement in mean (SD) hot flash scores at 6 weeks was greater for participants in the hypnosis group (baseline score, 88.7 [61.3] vs 6-week score, 41.3 [50.8]; 53.4% decrease) than those in the white noise group (baseline score, 94.6 [81.6] vs 6-week score, 55.9 [50.9]; 40.9% decrease; P = .04). The intervention group reported a significantly greater reduction in daily interference from baseline to week 6 (baseline mean [SD] HFRDIS score, 49.3 [22.6] vs 6-week score, 25.0 [22.4]; 49.3% decrease) compared with the control group (baseline mean [SD] HFRDIS score, 47.3 [22.4] vs 6-week score, 29.6 [22.0]; 37.4% decrease) as well as greater perceived benefits (90.3% [93 of 103] vs 64.3% [63 of 98]). Conclusions and Relevance: In this randomized clinical trial, the clinical hypnosis group experienced significantly greater reductions of hot flash scores and daily interference from hot flashes compared with the active control condition at week 6. This study suggests that hypnosis delivered through self-administered audio files is a clinically significant and effective method to reduce hot flashes in postmenopausal women. Trial Registration: ClinicalTrials.gov Identifier: NCT03572153.