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

NCT03459053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-09-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

CBART

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

Sponsors & Collaborators

  • Soroka University Medical Center

    collaborator OTHER
  • Ben-Gurion University of the Negev

    collaborator OTHER
  • Fondation de Myriam de Senarclens

    collaborator UNKNOWN
  • University of Haifa

    lead OTHER

Principal Investigators

  • Iris Harvardi, PhD · Soroka University Medical Center

  • Julie Cwikel, PhD · Ben-Gurion University of the Negev

  • Orly Sarid · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2021-04-20
Completion
2021-08-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03459053 on ClinicalTrials.gov