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Attention to Variability During Infertility

Primary Purpose

Infertility, Infertility, Female, Infertility, Male

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attention to Variability - Patient Only
Attention to Variability - Partner Only
Attention to Variability - Patient & Partner
Infertility Stories - Reading
Sponsored by
Harvard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Infertility, Fertility, Mindfulness, Ellen Langer, Wellbeing, Attention to Variability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Boston IVF/IVF New EnglandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Waitlist Control

Attention to Variability - Patient Only

Attention to Variability - Partner Only

Attention to Variability - Patient & Partner

Infertility Stories - Reading

Arm 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 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).

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).

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).

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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).
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.
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).
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.
Patient and Partner Wellbeing - Narrative question about their mind-body experience
Narrative question about their mind-body experience over the past three weeks

Secondary Outcome Measures

Ability to become pregnant
Question about whether or not they got pregnant

Full Information

First Posted
September 25, 2018
Last Updated
October 25, 2021
Sponsor
Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT03712982
Brief Title
Attention to Variability During Infertility
Official Title
Attention to Variability During Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
December 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Infertility, Female, Infertility, Male
Keywords
Infertility, Fertility, Mindfulness, Ellen Langer, Wellbeing, Attention to Variability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2.
Arm Title
Attention to Variability - Patient Only
Arm Type
Experimental
Arm 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).
Arm Title
Attention to Variability - Partner Only
Arm Type
Experimental
Arm 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).
Arm Title
Attention to Variability - Patient & Partner
Arm Type
Experimental
Arm 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).
Arm Title
Infertility Stories - Reading
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Attention to Variability - Patient Only
Intervention Description
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
Intervention Name(s)
Attention to Variability - Partner Only
Intervention Description
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
Intervention Name(s)
Attention to Variability - Patient & Partner
Intervention Description
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
Other
Intervention Name(s)
Infertility Stories - Reading
Other Intervention Name(s)
Reading Activity
Intervention Description
Reading Stories About Others' Infertility Experiences
Primary Outcome Measure Information:
Title
Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS)
Description
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).
Time Frame
Approximately 8 minutes
Title
Patient and Partner Wellbeing - Positive and Negative Affect Schedule (PANAS)
Description
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.
Time Frame
Approximately 8 minutes
Title
Patient and Partner Wellbeing - Rosenberg Self-Esteem Scale (RSE)
Description
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.
Time Frame
Approximately 5 minutes
Title
Patient and Partner Wellbeing - Satisfaction With Life Scale (SWLS)
Description
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).
Time Frame
Approximately 3 minutes
Title
Patient and Partner Wellbeing - Perceived Stress Scale (PSS)
Description
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.
Time Frame
Approximately 5 minutes
Title
Patient and Partner Wellbeing - Couples Satisfaction Index (CSI)
Description
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).
Time Frame
Approximately 11 minutes
Title
Patient and Partner Wellbeing - Tolerance of Ambiguity Scale
Description
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.
Time Frame
Approximately 10 minutes
Title
Patient and Partner Wellbeing - Narrative question about their mind-body experience
Description
Narrative question about their mind-body experience over the past three weeks
Time Frame
Approximately 8 minutes
Secondary Outcome Measure Information:
Title
Ability to become pregnant
Description
Question about whether or not they got pregnant
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karyn Gunnet-Shoval, PhD
Phone
6463301036
Email
gunnetshoval@fas.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Bercovitz
Email
kbercovitz@g.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karyn Gunnet-Shoval, PhD
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Bercovitz
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Langer, PhD
Organizational Affiliation
Harvard University
Official's Role
Study Director
Facility Information:
Facility Name
Boston IVF/IVF New England
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Domar, PhD
First Name & Middle Initial & Last Name & Degree
Karyn Gunnet-Shoval, PhD
First Name & Middle Initial & Last Name & Degree
Katherine Bercovitz
First Name & Middle Initial & Last Name & Degree
Ellen Langer, PhD
First Name & Middle Initial & Last Name & Degree
Alice Domar, PhD
First Name & Middle Initial & Last Name & Degree
Kristin Rooney

12. IPD Sharing Statement

Citations:
PubMed Identifier
27007939
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.
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Attention to Variability During Infertility

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