A Mind-body Intervention to Improve Body and/or Self Image
NCT ID: NCT02531997
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2015-08-31
2017-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Hypnotic Relaxation Therapy
Hypnotic relaxation will be performed in three sessions, two weeks apart, over 6 weeks. The hypnosis sessions will build on each other in terms of content.
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.
Progressive Muscle Relaxation (PMR)
The PMR will consist of progressive tensing and relaxing of the muscles from head to toe to a soothing sound of the participant's choosing.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* reported a change in body/self-image since diagnosis and wish to improve it. Two screening questions will be used: Has body image or self-image changed in an unwanted way since the cancer diagnosis? (Answer must be yes.) Would the potential participant like to be able to do something to improve body image or self-image? (Answer must be yes.)
* Concurrent cancer treatment of any kind is allowed, but the participant can also have completed all treatment
* Performance status of 2 or better
Exclusion Criteria
* Past history of sexual abuse.
* Currently on 2 or more antidepressant therapies for mood disturbance of any kind. Past use is allowed, just not current use.
* Currently on 2 or more anti-anxiety therapies. Past use is allowed, just not current use.
21 Years
FEMALE
No
Sponsors
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Breast Cancer Research Foundation
OTHER
University of Michigan
OTHER
Responsible Party
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Debra L. Barton
Professor
Principal Investigators
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Debra Barton, RN, PhD, FAAN
Role: PRINCIPAL_INVESTIGATOR
University of Michigan School of Nursing
Locations
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University of Michigan School of Nursing
Ann Arbor, Michigan, United States
Countries
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References
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Arring NM, Lafferty CK, Clark PM, Barton DL. The experience of women in a phase II trial of hypnosis and progressive muscle relaxation for body image: informing future research questions. J Psychosoc Oncol. 2024;42(1):148-158. doi: 10.1080/07347332.2023.2206406. Epub 2023 Apr 28.
Other Identifiers
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HUM00100709
Identifier Type: -
Identifier Source: org_study_id