DNA Degradation, Apoptotic, Fertility Disorders, Psychological Stress, Telomere Shortening
Conditions
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.
Interventions
BEHAVIORALCBART
Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
Sponsors
Soroka University Medical Center
Ben-Gurion University of the Negev
Fondation de Myriam de Senarclens
University of Haifa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | 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
| Measure | Time frame | Description |
|---|---|---|
| Cell Free DNA | 2 months | DNA particles outside the cell nuclous as found in plasma |
| Telomerase | 2 months | Enzyme related to telomere length, as found in PMBC |
| Pregnancy | 2 months | hCG levels higher than 8 in blood. |
Countries
Israel
Outcome results
None listed