Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes
- Conditions
- Hot Flashes
- Interventions
- Registration Number
- NCT01000623
- Lead Sponsor
- Mayo Clinic
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 71
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm IV mind-body intervention procedure Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. Arm I hypnotherapy Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Arm III hypnotherapy Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Arm IV placebo Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. Arm II mind-body intervention procedure Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8. Arm III placebo Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Arm I venlafaxine Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8. Arm II venlafaxine Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
- Primary Outcome Measures
Name Time Method Hot flash frequency measured by hot flash diary data Daily during study, weeks 2-8 Hot flash score measured by hot flash diary data Daily during study, weeks 2-8 Hot flash severity measured by hot flash diary data Daily during study, weeks 2-8
- Secondary Outcome Measures
Name Time Method Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire Week 8 Mood measured by Profile of Mood States questionnaire Week 8 Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized Week 5 Side effects measured by CTCAE v 3.0 and patient reports Once a week, weeks 2-8 Menopause quality of life measured by MENQOL questionnaire Week 8 Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire Week 8
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States