Attention to Variability During Infertility

NCT ID: NCT03712982

Last Updated: 2021-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2022-12-05

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.

Conditions

Infertility; Infertility, Female; Infertility, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Waitlist Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Attention to Variability - Patient Only

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).

Group Type: EXPERIMENTAL

Attention to Variability - Patient Only

Intervention Type: BEHAVIORAL

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

Attention to Variability - Partner Only

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).

Group Type: EXPERIMENTAL

Attention to Variability - Partner Only

Intervention Type: BEHAVIORAL

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology in their partner that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

Attention to Variability - Patient & Partner

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).

Group Type: EXPERIMENTAL

Attention to Variability - Patient & Partner

Intervention Type: BEHAVIORAL

Same as patient and partner only conditions, just that in this condition both the patient and partner do their corresponding intervention rather than only one of them.

Infertility Stories - Reading

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.

Group Type: ACTIVE_COMPARATOR

Infertility Stories - Reading

Intervention Type: OTHER

Reading Stories About Others' Infertility Experiences

Interventions

Attention to Variability - Patient Only

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

Intervention Type: BEHAVIORAL

Attention to Variability - Partner Only

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology in their partner that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

Intervention Type: BEHAVIORAL

Attention to Variability - Patient & Partner

Same as patient and partner only conditions, just that in this condition both the patient and partner do their corresponding intervention rather than only one of them.

Intervention Type: BEHAVIORAL

Infertility Stories - Reading

Reading Stories About Others' Infertility Experiences

Intervention Type: OTHER

Other Intervention Names

Reading Activity

Eligibility Criteria

Inclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard University

OTHER

Sponsor Role: lead

Responsible Party

Karyn Gunnet-Shoval

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karyn Gunnet-Shoval, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Katherine Bercovitz

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Ellen Langer, PhD

Role: STUDY_DIRECTOR

Harvard University

Locations

Boston IVF/IVF New England

Waltham, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karyn Gunnet-Shoval, PhD

Role: CONTACT

gunnetshoval@fas.harvard.edu

6463301036

Katherine Bercovitz

Role: CONTACT

kbercovitz@g.harvard.edu

Facility Contacts

Alice Domar, PhD

Role: primary

References

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.

Reference Type: RESULT

PMID: 27007939 (View on PubMed)

Other Identifiers

IRB16-1683

Identifier Type: -

Identifier Source: org_study_id