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

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ClinicalTrials.gov Identifier: NCT03459053
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 12, 2018
Soroka University Medical Center
Ben-Gurion University of the Negev
Fondation de Myriam de Senarclens
Information provided by (Responsible Party):
Johanna Czamanski-Cohen, University of Haifa

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.

Condition or disease Intervention/treatment
Psychological Stress DNA Degradation, Apoptotic Telomere Shortening Fertility Disorders Behavioral: CBART

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Research coordinator will conduct the randomization and all information will be deidentified. Investigator will not know who is in which group.
Primary Purpose: Supportive Care
Official Title: CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
Anticipated Study Start Date : May 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: CBART
6 weeks participation in CBART protocol before beginning IVF treatment
Behavioral: CBART
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
No Intervention: Wait control
Participants will receive treatment as usual and will be able to receive the intervention after the study is complete.

Primary Outcome Measures :
  1. Perceived Stress [ Time Frame: 2 months ]
    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 :
  1. Cell Free DNA [ Time Frame: 2 months ]
    DNA particles outside the cell nuclous as found in plasma

  2. Telomerase [ Time Frame: 2 months ]
    Enzyme related to telomere length, as found in PMBC

  3. Pregnancy [ Time Frame: 2 months ]
    hCG levels higher than 8 in blood.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459053

Contact: Johanna Czamanski-Cohen, PhD 972532775350 joczamanski@gmail.com

Sponsors and Collaborators
University of Haifa
Soroka University Medical Center
Ben-Gurion University of the Negev
Fondation de Myriam de Senarclens
Principal Investigator: Iris Harvardi, PhD Soroka University Medical Center
Principal Investigator: Julie Cwikel, PhD Ben-Gurion University of the Negev
Principal Investigator: Orly Sarid Ben-Gurion University of the Negev

Responsible Party: Johanna Czamanski-Cohen, Lecturer, University of Haifa
ClinicalTrials.gov Identifier: NCT03459053     History of Changes
Other Study ID Numbers: CBARTIVF
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms