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 : August 31, 2018
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||Phase|
|Psychological Stress DNA Degradation, Apoptotic Telomere Shortening Fertility Disorders||Behavioral: CBART||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||August 2020|
6 weeks participation in CBART protocol before beginning IVF treatment
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.
- 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.
- Cell Free DNA [ Time Frame: 2 months ]DNA particles outside the cell nuclous as found in plasma
- Telomerase [ Time Frame: 2 months ]Enzyme related to telomere length, as found in PMBC
- Pregnancy [ Time Frame: 2 months ]hCG levels higher than 8 in blood.
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, PhDfirstname.lastname@example.org|
|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|