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Attention to Variability During Infertility

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ClinicalTrials.gov Identifier: NCT03712982
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Karyn Gunnet-Shoval, Harvard University

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE December 5, 2016
Estimated Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS) [ Time Frame: Approximately 8 minutes ]
    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) [ Time Frame: Approximately 8 minutes ]
    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) [ Time Frame: Approximately 5 minutes ]
    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) [ Time Frame: Approximately 3 minutes ]
    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) [ Time Frame: Approximately 5 minutes ]
    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) [ Time Frame: Approximately 11 minutes ]
    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 [ Time Frame: Approximately 10 minutes ]
    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 [ Time Frame: Approximately 8 minutes ]
    Narrative question about their mind-body experience over the past three weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Ability to become pregnant [ Time Frame: 2 minutes ]
Question about whether or not they got pregnant
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Attention to Variability During Infertility
Official Title  ICMJE Attention to Variability During Infertility
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Infertility
  • Infertility, Female
  • Infertility, Male
Intervention  ICMJE
  • Behavioral: 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.
  • 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.
  • 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.
  • Other: Infertility Stories - Reading
    Reading Stories About Others' Infertility Experiences
    Other Name: Reading Activity
Study Arms  ICMJE
  • No Intervention: Waitlist Control
    All participants in this condition will complete all measures online at three different points in time, including one narrative response at T2.
  • Experimental: 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).
    Intervention: Behavioral: Attention to Variability - Patient Only
  • Experimental: 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).
    Intervention: Behavioral: Attention to Variability - Partner Only
  • Experimental: 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).
    Intervention: Behavioral: Attention to Variability - Patient & Partner
  • Active Comparator: 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.
    Intervention: Other: Infertility Stories - Reading
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 5, 2019
Estimated Primary Completion Date December 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karyn Gunnet-Shoval, PhD 6463301036 gunnetshoval@fas.harvard.edu
Contact: Katherine Bercovitz kbercovitz@g.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03712982
Other Study ID Numbers  ICMJE IRB16-1683
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karyn Gunnet-Shoval, Harvard University
Study Sponsor  ICMJE Harvard University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karyn Gunnet-Shoval, PhD Harvard University
Principal Investigator: Katherine Bercovitz Harvard University
Study Director: Ellen Langer, PhD Harvard University
PRS Account Harvard University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP