Last reviewed · How we verify
NCT03459053
CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
NA trial testing CBART in Psychological Stress in 88 participants. Completed in 1 August 2021.
20 April 2021
Quick facts
| Lead sponsor | University of Haifa |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 88 |
| Start date | 16 April 2019 |
| Primary completion | 20 April 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- CBART
Conditions studied
- Psychological Stress — all drugs for Psychological Stress →
- DNA Degradation, Apoptotic — all drugs for DNA Degradation, Apoptotic →
- Telomere Shortening — all drugs for Telomere Shortening →
- Fertility Disorders — all drugs for Fertility Disorders →
Sponsor
University of Haifa
Who can join
Adults 18 to 35, female only, with Psychological Stress or DNA Degradation, Apoptotic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03459053
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Psychological Stress
Currently open trials in the same condition.
- NCT07101458 — The Eswatini PRISM Study on Adolescents Living With HIV · NA · recruiting
- NCT06899165 — Psilocybin-Assisted Therapy for Intergenerational Trauma · Phase 2 · recruiting
- NCT06899308 — Health Surveillance at Constructor University Bremen (CUB) and Among HAW-Hamburg Employees · recruiting
- NCT06788106 — Effect of Aerobic Exercise With Synchronous Music on Functions Among Medical Students · NA · recruiting
- NCT06795061 — Fitness Buddy Program to Boost Physical Activity in University Students · NA · active not recruiting
Other University of Haifa trials
Trials by the same sponsor.
- NCT07379801 — The Musculoskeletal System During Puberty in Dancers With Scoliosis, and the Effect of an Exercise Program · NA · recruiting
- NCT07325929 — Online Radical Acceptance Intervention for Social Anxiety Disorder · NA · not yet recruiting
- NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
- NCT07367763 — The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults · active not recruiting
- NCT06932679 — Perception of Affordances and Obstacle Crossing in People With Parkinson's Disease and Healthy Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03459053 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Haifa
- Last refreshed: 29 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03459053.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing