Attention to Variability During Infertility

President and Fellows of Harvard College

Status: Unknown

Conditions: Infertility; Infertility, Male; Infertility, Female

Treatments: Behavioral: Attention to Variability - Patient & Partner; Behavioral: Attention to Variability - Partner Only; Other: Infertility Stories - Reading; Behavioral: Attention to Variability - Patient Only

Study type: Interventional

Funder types: Other

Identifiers

NCT03712982

IRB16-1683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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160 participants in 5 patient groups

Waitlist Control

No Intervention group

Description:

All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2.

Attention to Variability - Patient Only

Experimental group

Description:

All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. They will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).

Treatment:

Behavioral: Attention to Variability - Patient Only

Attention to Variability - Partner Only

Experimental group

Description:

All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. Partners of the infertile women will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).

Treatment:

Behavioral: Attention to Variability - Partner Only

Attention to Variability - Patient & Partner

Experimental group

Description:

All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. All participants (patients and partners) will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).

Treatment:

Behavioral: Attention to Variability - Patient & Partner

Infertility Stories - Reading

Active Comparator group

Description:

All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. They will also be instructed to do an at-home reading activity several times over a period of 2 weeks.

Treatment:

Other: Infertility Stories - Reading