Clinical trial NCT03712982: Attention to Variability During Infertility
Official title: Attention to Variability During Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Infertility, Female
Infertility, Male
Keywords: Infertility
Fertility
Mindfulness
Ellen Langer
Wellbeing
Attention to Variability
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: Infertility affects approximately one in seven couples, and it can be a devastating diagnosis and difficult experience for couples to endure. Ellen Langer, Ph.D., Director of the Langer Lab at Harvard, has spent several decades demonstrating evidence supporting a mind-body approach to improve wellbeing and overall functioning. Specifically, she asserts that Mindfulness in its most basic sense - paying attention in the moment - is enough to create both perceived (e.g., self-reported) and real (e.g., objective testing) change. Langer and her colleague, for example, demonstrated that "Trait mindfulness predicted the well-being of expecting mothers and better neonatal outcomes. Mindfulness training resulted in better health for the expecting mother". In this study, Mindfulness training refers to "attention to sensation variability." Such interventions are cost effective, minimally invasive, less time-consuming for practitioners and participants and generally easy to learn.

Langer and her colleague's study refers to pregnancy. Infertility is unlike pregnancy in its exact clinical diagnosis. Nevertheless, similar to pregnancy, infertility is considered a clinical condition affecting the body, in this case the reproductive system. Therefore, based on the results of studies like Langer and her colleague's, that used participants with clinical conditions affecting the reproductive system, the investigators propose similar mindfulness intervention (attention to sensation variability) research with infertile individuals. However, the investigators intend to extend our examination to also include a treatment group with the partners of the infertile individuals, as little, if any research, has attempted to do so previously. The investigators hypothesize that state mindfulness (groups exposed to mindfulness intervention) will improve wellbeing in the infertile patient and her partner and that trait mindfulness will predict ability to become pregnant.

Detailed description: Couples who have been trying to conceive for at least a year, have attended at least one doctor's appointment with an infertility/fertility specialist and have been advised by their physician to undergo their first IVF cycle will be recruited for this study.

Participants (couples) will be randomly assigned (assignment determined immediately following recruitment by a member of our research team), if eligible to one of four of five experimental conditions, which are described below. Assignment will occur on a 1:2:2:2:1 basis, such that for every two couples assigned to Conditions 2, 3 and 4 (mindfulness conditions) one couple will be assigned to Conditions 1 and 5 (control conditions). Couples will be told that we are interested in exploring if practicing mindful attention during the IVF process may improve patient and partner wellbeing during and following their first IVF cycle. All participants will be instructed to complete study measures, at three different points in time, via an online link.

Eligibility criteria: Inclusion criteria (infertile patients and their partners):

* 18+ years of age;
* Female patients who have been trying to conceive for at least a year, have attended at least one doctor's appointment with an infertility/fertility specialist and have been advised by their physician to undergo their first IVF cycle;
* Participants (patients and partners) with no known biological children.

Exclusion criteria (infertile patients and their partners):

* Individuals who do not meet the inclusion criteria above;
* Participants (patients and partners) with secondary infertility (already have a child);
* Participants (patients and partners) with a cut point score of less than 60 on the Mental Health Inventory (MHI-5) (assessed at phone screening).

Primary outcomes:
measure: Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS)
timeFrame: Approximately 8 minutes
measure: Patient and Partner Wellbeing - Positive and Negative Affect Schedule (PANAS)
timeFrame: Approximately 8 minutes
measure: Patient and Partner Wellbeing - Rosenberg Self-Esteem Scale (RSE)
timeFrame: Approximately 5 minutes
measure: Patient and Partner Wellbeing - Satisfaction With Life Scale (SWLS)
timeFrame: Approximately 3 minutes
measure: Patient and Partner Wellbeing - Perceived Stress Scale (PSS)
timeFrame: Approximately 5 minutes
measure: Patient and Partner Wellbeing - Couples Satisfaction Index (CSI)
timeFrame: Approximately 11 minutes
measure: Patient and Partner Wellbeing - Tolerance of Ambiguity Scale
timeFrame: Approximately 10 minutes
measure: Patient and Partner Wellbeing - Narrative question about their mind-body experience
timeFrame: Approximately 8 minutes
Secondary outcomes:
measure: Ability to become pregnant
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF/IVF New England
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Karyn Gunnet-Shoval, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Katherine Bercovitz
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Ellen Langer, PhD
role: STUDY_DIRECTOR
References:
citation: Zilcha-Mano S, Langer E. Mindful Attention to Variability Intervention and Successful Pregnancy Outcomes. J Clin Psychol. 2016 Sep;72(9):897-907. doi: 10.1002/jclp.22294. Epub 2016 Mar 23.