CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
NCT ID: NCT03459053
Last Updated: 2021-09-29
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
88 participants
INTERVENTIONAL
2019-04-16
2021-08-01
Brief Summary
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CB-ART is a 6-session treatment protocol that has been utilized with women coping with stress, depression and pain and is effective in reducing these indicators, developed and evaluated by our research team. The treatment protocol emphasizes processing together with the client's recalled image, symptom or memory (ISM) pertaining to a current distressing mental or physical state. CB-ART is a multi-method model that integrates cognitive behavioral interventions and art-based stress reduction interventions. The innovation in this method is the transformation of imagined and drawn images and memories rather than solely verbally discussing their contents. The focus is on changing compositional elements that comprise each image and memory, thus providing a therapeutic venue to reframe and transform stress producing, recalled images and memories and reduce symptoms of perceived stress. Art making is beneficial for eliciting an emotional response and provides a concrete platform to conduct the cognitive processing that initiate change on the paper and then in the mind. Furthermore, the soothing qualities of interacting with art making foster and enhance behavioral relaxation techniques.
Our study population, women with infertility problems, who are designated to undergo IVF treatment and have been identified to have elevated perceived stress scores on the Perceived Stress Scale (above 15) will be randomized and allocated to receive the CB-ART intervention tailored to reduce stress or treatment as usual.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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CBART
6 weeks participation in CBART protocol before beginning IVF treatment
CBART
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
Wait control
Participants will receive treatment as usual and will be able to receive the intervention after the study is complete.
No interventions assigned to this group
Interventions
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CBART
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
Eligibility Criteria
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Inclusion Criteria
* between the ages of 18-35
* without an axis I psychiatric diagnosis
Exclusion Criteria
* Do not speak Hebrew
* Have an Axis I psychiatric diagnosis that would prevent them from participating in the intervention
18 Years
35 Years
FEMALE
No
Sponsors
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Soroka University Medical Center
OTHER
Ben-Gurion University of the Negev
OTHER
Fondation de Myriam de Senarclens
UNKNOWN
University of Haifa
OTHER
Responsible Party
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Johanna Czamanski-Cohen
Lecturer
Principal Investigators
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Iris Harvardi, PhD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Julie Cwikel, PhD
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Orly Sarid
Role: PRINCIPAL_INVESTIGATOR
Ben-Gurion University of the Negev
Locations
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Soroka University Medical Center
Beersheba, , Israel
Countries
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References
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Czamanski-Cohen J, Sarid O, Cwikel J, Levitas E, Lunenfeld E, Douvdevani A, Har-Vardi I. Decrease in cell free DNA levels following participation in stress reduction techniques among women undergoing infertility treatment. Arch Womens Ment Health. 2014 Jun;17(3):251-3. doi: 10.1007/s00737-013-0407-2. Epub 2014 Jan 14.
Czamanski-Cohen J, Sarid O, Cwikel J, Lunenfeld E, Douvdevani A, Levitas E, Har-Vardi I. Increased plasma cell-free DNA is associated with low pregnancy rates among women undergoing IVF-embryo transfer. Reprod Biomed Online. 2013 Jan;26(1):36-41. doi: 10.1016/j.rbmo.2012.09.018. Epub 2012 Oct 4.
Czamanski-Cohen J, Sarid O, Cwikel J, Douvdevani A, Levitas E, Lunenfeld E, Har-Vardi I. Cell-free DNA and telomere length among women undergoing in vitro fertilization treatment. J Assist Reprod Genet. 2015 Nov;32(11):1697-703. doi: 10.1007/s10815-015-0581-4. Epub 2015 Oct 5.
Sarid O, Cwikel J, Czamanski-Cohen J, Huss E. Treating women with perinatal mood and anxiety disorders (PMADs) with a hybrid cognitive behavioural and art therapy treatment (CB-ART). Arch Womens Ment Health. 2017 Feb;20(1):229-231. doi: 10.1007/s00737-016-0668-7. Epub 2016 Sep 19.
Other Identifiers
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CBARTIVF
Identifier Type: -
Identifier Source: org_study_id
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