The Effect of the Mind/Body Program for Fertility, Hungarian Version, on Psychological Well-Being and Assisted Reproduction Technology (ART) Outcomes: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility, Female
- Sponsor
- Semmelweis University
- Enrollment
- 177
- Locations
- 2
- Primary Endpoint
- Clinical pregnancy
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Involuntary childlessness is an emotionally stressful experience; however, psychosocial counseling is typically not available in Hungarian routine fertility care. The aim of this randomized controlled trial (RCT) is to examine the effectiveness of a Mind/Body psychological fertility intervention for women in reproductive treatment. We hypothesize that participants of the Mind/Body Program for Fertility, Hungarian version, will have more favorable psychological well-being, ART outcome results than participants of the Fertility Support Groups.
Detailed Description
Involuntary childlessness imposes significant psychological burden on those affected, particularly those involved in assisted reproductive technology (ART). The reduction of psychological distress has been shown to improve the quality of life of those affected and to possibly increase chances of pregnancy. While in more developed countries psychological support is largely available in routine fertility care, it is not yet part of the Hungarian ART protocol. In this study, the effects of a psychosocial intervention, namely, the Hungarian version of the Mind/Body Program for Fertility (Domar et al., 2011), will be tested on the psychological well-being and ART outcomes of women in reproductive treatment, in a randomized controlled pre-post design. For this purpose, women in ART treatment will fill in screening questionnaires (on depression, anxiety, stress, etc.), and moderate to high scorers will be randomized into an intervention (Mind/Body) group (N=70) and a comparison intervention (Fertility Support) group (N=70), lasting for 10 weeks each, before and/or during an ART cycle. Both interventions will be delivered by the same clinical psychologist, listed as central contact person below, officially trained in the Mind/Body Program for Fertility by Dr. Alice Domar at Boston IVF, Waltham, Massachusetts. A smartphone application for rating subjective stress levels twice a day, from the start of the stimulation to the day of the pregnancy test, will also be administered. Additionally, whole-night sleep EEGs will be recorded. Medical data (such as diagnosis, hormone levels, previous treatment cycles, etc.) and sociodemographic (such as age, education, etc.) and psychological variables (such as personality traits, chronotype, intelligence, etc.) as potential moderators, as well as ART outcomes will be reported. Data of respondents willing to fill in pre- and post-questionnaires but 1) not motivated to take part in the study, or 2) motivated to take part in the study, but not able to make it, will be registered but excluded from statistical analysis comparing RCT results.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All women awaiting or undergoing infertility treatment (insemination, in vitro fertilization or intracytoplasmic sperm injection) at the Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University, Budapest, who:
- •give informed consent to participating in the study
- •have sufficient knowledge of the Hungarian language
Exclusion Criteria
- •active psychotic episode
- •severe depression or other major psychiatric diagnoses
- •substance abuse
- •eating disorders
Outcomes
Primary Outcomes
Clinical pregnancy
Time Frame: through study completion, an average of 2 years
Rate of clinical pregnancies at post-measurement
Mean change from baseline in results on the Fertility Quality of Life tool
Time Frame: through study completion, an average of 2 years
Mean change from baseline in results on the Fertility Quality of Life (FertiQoL) Core Scale, subscales and Treatment Module
Mean change from baseline in results on the SCREENIVF tool
Time Frame: through study completion, an average of 2 years
Mean change from baseline in results on the SCREENIVF tool and its subscales
Secondary Outcomes
- Mean change from baseline on a Likert scale measuring strength of intention to continue treatment(through study completion, an average of 2 years)