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

NCT03459053 | Completed

• 1 other identifier: CBARTIVF
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cell Free DNA

  2 months

• Telomerase

  2 months

• Pregnancy

  2 months

Study Arms (2)

CBART

EXPERIMENTAL

6 weeks participation in CBART protocol before beginning IVF treatment

Behavioral: CBART

Wait control

NO INTERVENTION

Participants will receive treatment as usual and will be able to receive the intervention after the study is complete.

Interventions

CBART BEHAVIORAL

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

CBART

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Soroka University Medical Center: collaborator
• Ben-Gurion University of the Negev: collaborator
• Fondation de Myriam de Senarclens: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (4)

• 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.

  PMID: 24420416 BACKGROUND

• 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.

  PMID: 23182744 BACKGROUND

• 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.

  PMID: 26438644 BACKGROUND

• 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.

  PMID: 27645306 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinator will conduct the randomization and all information will be deidentified. Investigator will not know who is in which group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 8, 2018
• Study Start: April 16, 2019
• Primary Completion: April 20, 2021
• Study Completion: August 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)