Clinical trial NCT03459053: CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
Official title: CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
DNA Degradation, Apoptotic
Telomere Shortening
Fertility Disorders
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Soroka University Medical Center
name: Ben-Gurion University of the Negev
name: Fondation de Myriam de Senarclens
First posted: 2018-03-08
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is a randomized controlled trial of a cognitive behavioral interventions and an art-based stress reduction treatment protocol (CB-ART) with 100 women, identified with elevated perceived stress, before undergoing IVF treatment; in order to examine its effect on perceived stress, plasma CFD, telomere length and pregnancy rates.

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.


Eligibility criteria: Inclusion Criteria:

* Hebrew speaking nulliparous women
* between the ages of 18-35
* without an axis I psychiatric diagnosis

Exclusion Criteria:

* Women over 35
* Do not speak Hebrew
* Have an Axis I psychiatric diagnosis that would prevent them from participating in the intervention

Primary outcomes:
measure: Perceived Stress
timeFrame: 2 months
Secondary outcomes:
measure: Cell Free DNA
timeFrame: 2 months
measure: Telomerase
timeFrame: 2 months
measure: Pregnancy
timeFrame: 2 months
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Iris Harvardi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Julie Cwikel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Orly Sarid
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.