CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
Primary Purpose
Psychological Stress, DNA Degradation, Apoptotic, Telomere Shortening
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CBART
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Stress
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
Sites / Locations
- Soroka University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CBART
Wait control
Arm Description
6 weeks participation in CBART protocol before beginning IVF treatment
Participants will receive treatment as usual and will be able to receive the intervention after the study is complete.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cell Free DNA
DNA particles outside the cell nuclous as found in plasma
Telomerase
Enzyme related to telomere length, as found in PMBC
Pregnancy
hCG levels higher than 8 in blood.
Full Information
NCT ID
NCT03459053
First Posted
March 2, 2018
Last Updated
September 28, 2021
Sponsor
University of Haifa
Collaborators
Soroka University Medical Center, Ben-Gurion University of the Negev, Fondation de Myriam de Senarclens
1. Study Identification
Unique Protocol Identification Number
NCT03459053
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
Collaborators
Soroka University Medical Center, Ben-Gurion University of the Negev, Fondation de Myriam de Senarclens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, DNA Degradation, Apoptotic, Telomere Shortening, Fertility Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Research coordinator will conduct the randomization and all information will be deidentified. Investigator will not know who is in which group.
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBART
Arm Type
Experimental
Arm Description
6 weeks participation in CBART protocol before beginning IVF treatment
Arm Title
Wait control
Arm Type
No Intervention
Arm Description
Participants will receive treatment as usual and will be able to receive the intervention after the study is complete.
Intervention Type
Behavioral
Intervention Name(s)
CBART
Intervention Description
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
Primary Outcome Measure Information:
Title
Perceived Stress
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Cell Free DNA
Description
DNA particles outside the cell nuclous as found in plasma
Time Frame
2 months
Title
Telomerase
Description
Enzyme related to telomere length, as found in PMBC
Time Frame
2 months
Title
Pregnancy
Description
hCG levels higher than 8 in blood.
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Harvardi, PhD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Cwikel, PhD
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orly Sarid
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Be'er Sheva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24420416
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.
Results Reference
background
PubMed Identifier
23182744
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.
Results Reference
background
PubMed Identifier
26438644
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.
Results Reference
background
PubMed Identifier
27645306
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.
Results Reference
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CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
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