Mindset Management for Stress in Women With Infertility
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Virginia Polytechnic Institute and State University
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to test the effect of a mindset management intervention on stress levels in women with infertility. The main question it aims to answer is:
Can the Organic Conceptions approach decrease stress levels in women with infertility?
Participants in both groups will be asked to complete three surveys at three time points. The intervention group will complete the Organic Conceptions program, while the control group will not complete an intervention.
Researchers will compare the intervention group and control group to see if the Organic Conceptions mindset management program decreases stress levels in women with infertility.
Is the Organic Conceptions mindset management program a promising treatment for stress in women with infertility?Yes, the Organic Conceptions mindset management program is a promising treatment for stress in women with infertility. Research shows that mind-body and mindfulness-based interventions can effectively reduce stress, anxiety, and depression in infertile women. These treatments help improve mental health and may even increase the chances of pregnancy.156711
What safety data exists for the Mindset Management for Stress in Women With Infertility treatment?The provided research does not directly address safety data for the specific treatment known as the Organic Conceptions mindset management program or its variants. However, the studies suggest that mind-body interventions, which may include similar approaches, are generally associated with reduced psychological distress and improved mental health outcomes in infertile women. No specific safety concerns are mentioned, but further research, particularly randomized controlled trials, is recommended to better understand the safety and efficacy of these interventions.34789
What data supports the idea that Mindset Management for Stress in Women With Infertility is an effective treatment?The available research shows that mind-body interventions, which include programs like the Organic Conceptions mindset management program, can help reduce anxiety and depression in women dealing with infertility. These interventions may also improve the chances of pregnancy. Although the improvements in mental health are generally small to moderate, they are consistent across several studies. Compared to other treatments like yoga or mindfulness, these programs are similarly effective in reducing stress and improving emotional well-being.247810
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for English-speaking women who are new patients at Shady Grove Fertility in Roanoke or Richmond, have infertility issues, and can access a smartphone, tablet, or computer with internet.Participant Groups
The study tests if the Organic Conceptions mindset management program can reduce stress levels in women with infertility. Participants will be split into two groups; one will use the program while the other won't. Their stress levels will be compared over time through surveys.
2Treatment groups
Experimental Treatment
Active Control
Group I: Organic Conceptions intervention groupExperimental Treatment1 Intervention
Will complete Organic Conceptions intervention.
Group II: Control groupActive Control1 Intervention
Will not complete Organic Conceptions intervention.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Shady Grove FertilityRoanoke, VA
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
Shady Grove Fertility Reproductive Science CenterCollaborator
References
Stress of female infertility: relations to length of treatment. [2018]The psychology of infertile women was investigated with a battery of psychological tests consisting of a semistructured interview, State Trait Anxiety Inventory (STAI), Center for Epidemiologic Studies Depression Scale (CES-D), and Cornell Medical Index (CMI). The subjects were 107 infertile women being treated for infertility. The semistructured interviews revealed that the stress factor for infertile women changes with the length of infertility. In the early states, the main stress is related to a physical inferiority complex, while later it changes into stress about what others outside the family say. According to STAI, CES-D and CMI, infertile women are considered to become more depressive the longer treatment persists. Therefore, counseling for infertile women should be adapted to long-term treatment.
Body-mind-spirit intervention for IVF women. [2022]Literature supports the efficacy of psychosocial intervention for infertile women. An eastern body-mind-spirit group intervention has been developed to help infertile women in the Chinese population cope with the distress arising from IVF treatment.
[The psychosocial consequences of infertility and fertility treatment]. [2012]Infertility and its treatment are severe, chronic, low-control stressors. Among women unsuccessful treatment is associated with increased risk of developing depressive symptoms. Among men infertility is associated with more negative emotional responses. Lifelong involuntary childlessness is associated with reduced mental well-being. It is recommended in the future to integrate mental health professionals at fertility clinics in Denmark in order to secure that also the psychosocial consequences of infertility and fertility treatment are taken care of with the highest professional standard based on scientific knowledge within this field.
Mind-body group treatment for women coping with infertility: a pilot study. [2016]To evaluate the feasibility of a 10-week mind-body intervention (MBI) for women coping with fertility challenges, examine the impact of an MBI on psychological distress and cortisol levels, and assess adherence to MBI skills 12-months after completion of the intervention.
Factor structure of the General Health Questionnaire-28 (GHQ-28) from infertile women attending the Yazd Research and Clinical Center for Infertility. [2022]Nowadays, infertility problems have become a social concern, and are associated with multiple psychological and social problems. Also, it affects the interpersonal communication between the individual, familial, and social characteristics. Since women are exposed to stressors of physical, mental, social factors, and treatment of infertility, providing a psychometric screening tool is necessary for disorders of this group.
What Psychiatric Interventions Are Used for Anxiety Disorders in Infertile Couples? A Systematic Review Study. [2020]Objective: Infertility causes psychological and social problems in many infertile women, men, and couples, and the most common of which is anxiety. Also, assisted reproductive treatments (ART) increase anxiety. Numerous medical and community associations have strongly recommended psychosocial interventions and counselling to help infertile couples. Method : A review was done on studies published from 1982 to 2018 that were indexed in Medline, ISI Web of Knowledge, and Scopus. The references of each article were used for more resources and references. Results: Most psychosocial interventions were effective on infertile women, men, and couples. These articles showed a significant decrease in anxiety with CBT interventions, body-mind interventions, and other interventions. Conclusion: All interventions based on CBT, most interventions based on body-mind, and some other interventions are effective in treating anxiety in infertile women and men.
The effect of mind-body interventions on psychological and pregnancy outcomes in infertile women: a systematic review. [2020]Preliminary evidence suggests that mind-body interventions, including mindfulness-based interventions and yoga, may be effective in reducing mental health difficulties and psychological distress in infertile patients undergoing fertility treatments. We systematically reviewed and synthesized current medical literature of the effectiveness of mind-body interventions in reducing the severity of psychological distress and improving marital function and pregnancy outcomes in infertile women/couple. Databases including PsychINFO, PubMed, EMBASE, and the Cochrane Library were searched for relevant studies. Manual searches were conducted in relevant articles. We included 12 studies that met the inclusion criteria. Four studies were randomized controlled trials (RCT), 4 non-randomized controlled trial (NRCT), and 4 uncontrolled studies (UCT). Participation in a mind-body intervention was associated with reduced anxiety trait and depression scores. The reduction was of low or moderate amplitude in most studies. Our review offers evidence for the effectiveness of mind-body interventions in reducing anxiety state and depression in infertile women and a possible improvement in pregnancy rate. Further RCTs with a precise timing of intervention are needed.
An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial. [2020]To determine if an internet-based mind/body program would lead to participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention. Secondary exploratory goals were to examine reduced distress over the course of the intervention and increased likelihood to conceive.
Mindfulness-based program to support lifestyle modification and weight loss in infertile women: randomized controlled trial. [2022]We evaluated the short-term effects of a mindfulness-based program (MBP) on weight loss through lifestyle modification in infertile women who were overweight or obese.
An Epistemological Perspective of Integrated Multidisciplinary Treatment When Dealing With Infertile Women With a Parenthood Goal: The Importance of Matterpsychic Perspective. [2021]This article proposes a multidisciplinary work perspective on couples who undergo assisted reproductive technology (ART) treatments, with particular attention paid to the treatment of women. The epistemological references underlying a vision of infertility and sterility that respect the psyche-soma unity of the person are illustrated: the biopsychosocial model and the psychoneuroimmunology and psychosomatic contemporary models of health and illness. Based on clinical experience in a private and institutional setting, different steps in the course of treatment are described with the related areas of psychological work: from the search for pregnancy to the choice of adhering to an ART treatment, to conception, up to delivery and beyond. The implications of the work are targeted at a better qualification of psychological interventions in this specific multidisciplinary area.
Mindfulness improves the mental health of infertile women: A systematic review. [2023]Infertility in women causes mental health problems, the bad ones. Women with infertility need psychological treatment using mindfulness interventions. This study's purpose was to analyze mindfulness's effect on the mental health of women with infertility through a systematic review. The method used in this systematic review was by searching through the following databases; ProQuest database, Wiley Library, Pubmed, Scopus, Science Direct, Sage Journal, Cochrane Library, and Cambridge Core from January 2011 to December 2021. Nine articles met the inclusion criteria. Results show that the use of mindfulness was found to be effective in reducing mental disorders in women with infertility. Nine articles that meet the criteria for inclusion. According to a study on the effects of mindfulness on infertile women, affect increasing mental health levels by reducing mental health disorder scores. Mindfulness has been proven to be an effective intervention for women undergoing infertility-related mental disorders such as stress, anxiety, and depression. However, different types of mindfulness-based interventions are used to target different mental health issues. For example, Mindfulness-Based Stress Reduction (MBSR) targets stress and anxiety while Mindfulness-Based Cognitive Therapy (MBCT) targets depression. Additionally, specific mindfulness for example, for the midwifery profession can be developed to improve the quality and treatment outcomes of healthcare for women struggling with infertility problems.