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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: CBART


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell Free DNA | DNA particles outside the cell nuclous as found in plasma | 2 months | 
| Telomerase | Enzyme related to telomere length, as found in PMBC | 2 months | 
| Pregnancy | hCG levels higher than 8 in blood. | 2 months |