Attention to Variability During Infertility

NCT03712982 | Completed

• 1 other identifier: IRB16-1683
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Infertility, Female; Infertility, Male

Keywords

Infertility; Fertility; Mindfulness; Ellen Langer; Wellbeing; Attention to Variability

Outcome Measures

Primary Outcomes (8)

• Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS)

  4 subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Flexibility' (includes 4 items); 'Novelty Seeking' (6 items); 'Novelty Producing' (6 items); 'Engagement' (5 items). 7 items are reverse scored. To determine overall Mindfulness score, sum all items (items 1-21).

  Approximately 8 minutes

• Patient and Partner Wellbeing - Positive and Negative Affect Schedule (PANAS)

  Scale consists of a number of words that describe different feelings and emotions. Participants indicate to what extent they have a particular way in the past few hours. The scale ranges from 1 (Very slightly or not at all) to 5 (extremely). Individuals decide which of the 20 questions are positive and which are negative. Scores are then added for the 10 positive words and separately for the 10 negative words. The scores generated will vary along the scale of 10 - 50, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect.

  Approximately 8 minutes

• Patient and Partner Wellbeing - Rosenberg Self-Esteem Scale (RSE)

  A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be unidimensional. All items are answered using a 4-point Likert scale format ranging from 1 (strongly agree) to 4 (strongly disagree). Scoring: Items 2, 5, 6, 8, 9 are reverse scored. Scores are then summed for all ten items on a continuous scale. Higher scores indicate higher self-esteem.

  Approximately 5 minutes

• Patient and Partner Wellbeing - Satisfaction With Life Scale (SWLS)

  A 5-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 1 (strongly disagree) to 1 (strongly agree). Scoring : Scoring should be kept continuous (scores are summed up on each item).

  Approximately 3 minutes

• Patient and Partner Wellbeing - Perceived Stress Scale (PSS)

  The following questions ask about one's feelings and thoughts during the past month. In each question, individuals are asked how often they felt or thought a certain way. Scoring: Each item is rated on a 5-point scale ranging from (0) never to (4) almost always. Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items.

  Approximately 5 minutes

• Patient and Partner Wellbeing - Couples Satisfaction Index (CSI)

  A 32-item scale designed to measure one's satisfaction in a relationship. The scale has a variety of items with different response scales and formats. Question Scoring: 1: 0 (Extremely Unhappy) to 6 (Perfect); 2-4: 0 (Always Disagree) to 5 (Always Agree); 5: 0 (Never) to 5 (All the time); 6: 0 (All the time) to 5 (Never); 7-18: 0 (Not at all True) to 5 (Completely True); 19-22: 0 (Not at All) to 5 (Completely); 23: 0 (Worse than all others \[extremely bad\]) to 5 (Better than all others \[extremely good\]); 24-25: 0 (Never) - 5 (More Often); 26: 0 (Boring) to 5 (Interesting); 27: 0 (Bad) to 5 (Good); 28: 0 (Empty) to 5 (Full); 29: 0 (Lonely) to 5 (Friendly); 30: 0 (Fragile) to Sturdy (5); 31: 0 (Discouraging) to 5 (Hopeful); 32: 0 (Miserable) to 5 (Enjoyable).

  Approximately 11 minutes

• Patient and Partner Wellbeing - Tolerance of Ambiguity Scale

  The instrument consists of 16 items on a scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). High scores indicate a greater intolerance for ambiguity. To score the instrument, the even-numbered items must be reverse-scored. Three subscales can also be computed to reveal the major source of intolerance of ambiguity - novelty (N), complexity (c), or insolubility (I). Having intolerance of ambiguity means that an individual tends to perceive situations as threatening rather than promising. Lack of information or uncertainty, for example, would make such a person uncomfortable. Ambiguity arises from three main sources: novelty, complexity and insolubility.

  Approximately 10 minutes

• Patient and Partner Wellbeing - Narrative question about their mind-body experience

  Narrative question about their mind-body experience over the past three weeks

  Approximately 8 minutes

Secondary Outcomes (1)

• Ability to become pregnant

  2 minutes

Study Arms (5)

Waitlist Control

NO INTERVENTION

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

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).

Behavioral: Attention to Variability - Patient Only

Attention to Variability - Partner Only

EXPERIMENTAL

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).

Behavioral: Attention to Variability - Partner Only

Attention to Variability - Patient & Partner

EXPERIMENTAL

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).

Behavioral: Attention to Variability - Patient & Partner

Infertility Stories - Reading

ACTIVE COMPARATOR

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.

Other: Infertility Stories - Reading

Interventions

Attention to Variability - Partner Only 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 - Partner Only

Infertility Stories - Reading OTHER

Reading Stories About Others' Infertility Experiences

Also known as: Reading Activity

Infertility Stories - Reading

Attention to Variability - Patient Only 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 - Patient Only

Attention to Variability - Patient & Partner 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.

Attention to Variability - Patient & Partner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Boston IVF/IVF New England

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

• 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.

  PMID: 27007939 RESULT

MeSH Terms

Conditions

Infertility; Infertility, Female; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• Karyn Gunnet-Shoval, PhD

  Harvard University

  PRINCIPAL INVESTIGATOR

• Katherine Bercovitz

  Harvard University

  PRINCIPAL INVESTIGATOR

• Ellen Langer, PhD

  Harvard University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 19, 2018
• Study Start: December 5, 2016
• Primary Completion: December 18, 2019
• Study Completion: January 29, 2021
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)