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OpenTrials
Completed

NCT Number: NCT03459053

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Soroka University Medical Center

Beersheba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBART

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Fondation de Myriam de Senarclens
  • Soroka University Medical Center

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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