CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF

Psychological Stress Clinical Trial

Official title:

CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459053
• Other study ID #: CBARTIVF
• Status: Completed
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 1, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• DNA Degradation, Apoptotic
• Fertility Disorders
• Psychological Stress
• Stress, Psychological
• Telomere Shortening

Intervention

Behavioral:
• CBART
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheva

Sponsors (4)

Lead Sponsor	Collaborator
University of Haifa	Ben-Gurion University of the Negev, Fondation de Myriam de Senarclens, Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress	The perceived stress scale (Cohen, Kamarck & Mermelstein, 1994) is a 10 item scale measuring perceived stress by asking 10 questions in which participants are requested to list on a scale from 0- never to 4- very frequently, how often they have experienced different stress related occurrences in the past month. The scale is calculated by summing the items (4 items reversed) with scores ranging from 0 - 40. Higher scores indicate higher perceived stress, with the mean US score being 16.	2 months
Secondary	Cell Free DNA	DNA particles outside the cell nuclous as found in plasma	2 months
Secondary	Telomerase	Enzyme related to telomere length, as found in PMBC	2 months
Secondary	Pregnancy	hCG levels higher than 8 in blood.	2 months