NCT02531997

A Mind-body Intervention to Improve Body and/or Self Image

A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if hypnotic relaxation therapy is a more effective intervention for improving self-image in women who have been diagnosed with breast or gynecologic cancer when compared to progressive muscle relaxation therapy.

Detailed description

This will be a phase II randomized controlled trial involving two arms: hypnotic relaxation and progressive muscle relaxation (PMR), using a 2:1 randomization schedule. 1. Evaluate the impact of a hypnotic relaxation intervention compared to progressive muscle relaxation on body image distress. Hypothesis 1: Women randomized to the hypnotic relaxation will have significantly more improvement in body image distress as measured by the Impact of Treatment Scale than women randomized to receive progressive muscle relaxation at 6 weeks. 2. Evaluate the impact of a hypnotic relaxation intervention compared to progressive relaxation on sexual self-image, sexual health, and mood. Hypothesis 2: Women randomized to hypnotic relaxation will show significantly more improvement on the Sexual Self-Schema Scale, the Patient Reported Outcomes Measurement Information System (PROMIS) sexual health scale and the Positive-Negative Affect Scale (PANAS) than women receiving progressive relaxation at 6 weeks. 3. Evaluate the side effects of hypnotic and progressive muscle relaxation. Hypothesis 3a: Hypnotic relaxation will not be associated with significantly more negative side effects than progressive muscle relaxation. Hypothesis 3b: Neither hypnotic nor progressive muscle relaxation will be associated with negative side effects. 4. Explore the physiologic effects of hypnotic relaxation compared to progressive muscle relaxation by evaluating cortisol slopes and comparing am/pm cortisol values. Hypothesis 4a: Women receiving hypnotic relaxation will have a steeper cortisol slope, higher am and lower pm cortisol concentrations at the end of 6 weeks compared with women receiving progressive muscle relaxation. Women will be referred from providers in the Breast and Gynecology Clinics of the University of Michigan Cancer Center as well as the Symptom Management, Sexual Health and Psycho-Oncology clinics. The study coordinator will provide education about the trial and a consent form will be provided for review. If a woman decides to participate, she will sign the consent form. Sessions will be held at Dr. Barton's behavioral research office located on Washtenaw Avenue in Ann Arbor, where there is privacy, a recliner, a relaxing environment, and convenient parking. Both intervention arms will involve three sessions that will occur at 2 week intervals. Each visit will last about 40 minutes to an hour.

Conditions

• Breast Cancer
• Ovarian Cancer
• Uterine Cancer
• Cervical Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Hypnotic Relaxation Therapy	There are 3 induction scripts that build upon each other, each about 20 minutes in length. The first focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second focuses more on body image related to sexuality, sexual desire, passion, and romanticism. The third includes suggestions from the previous inductions, but adds a behavior that the woman chooses to incorporate for the last 2 weeks of the intervention. A digital recording will be provided of the intervention content for home practice.
BEHAVIORAL	Progressive Muscle Relaxation	Women will be instructed how to do progressive relaxation and will be given the opportunity to ask questions and express concerns. The research therapist will utilize a script to focus the conversation on relaxation and planning the implementation of the behavior. Participants will be given a digital recording of 4 pleasant background sounds to facilitate their relaxation practice. Home practice will be encouraged.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-08-25
• Last updated: 2017-12-12

Locations

1 site across 1 country: United States