NCT01000623

Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes

Evaluation of a Biobehavioral Intervention for Hot Flashes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer. Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is not yet known whether giving venlafaxine together with hypnosis or focused attention is more effective in treating hot flashes. Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or focused attention in treating patients with hot flashes.

Detailed description

Objectives: I. To evaluate the effect of hypnosis plus venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes. II. To evaluate the side effects associated with hypnosis with venlafaxine versus focused attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for reducing hot flashes. III. To evaluate the effects of the four treatment arms on mood, sleep, hot flash interference and menopause quality of life. IV. To explore the role of expectancy and hypnotizability as moderators of the effect of each of the four treatment arms in reducing hot flashes. Outline: Patients are randomized to 1 of 4 intervention arms. Patients receive oral venlafaxine or a placebo and practice hypnosis or focused attention.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	venlafaxine	Given orally
DRUG	placebo	Given orally
PROCEDURE	hypnotherapy	Practice hypnosis
PROCEDURE	mind-body intervention procedure	Practice focused attention

Timeline

• Start date: 2010-01-31
• Primary completion: 2012-02-28
• Completion: 2015-09-08
• First posted: 2009-10-23
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States