Online Mind/Body Program for Fertility

Fertility & Well-Being: Mind/Body Protocol

This pilot-study assesses the feasibility and acceptability of an Online Mind/Body Fertility Program, designed to help individuals and/or couples cope with the physical and emotional impact of infertility by learning special relaxation strategies and improving lifestyle habits. Participants included women experiencing infertility who had not given birth to a child. Half of participants received access to the 10-week Online Mind-Body Program and the other half were placed on a waiting-list.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Online Mind/Body Program for Fertility

Detailed Description

Infertility is defined as the inability to conceive a child. A couple may be acknowledged as infertile if conception has not occurred after 12 months of having regular, unprotected intercourse. Over six million couples in the United States are affected by infertility. Research suggests that there is a relationship between psychological distress and infertility, but the relationship is complex. The information from this study will be used to better understand the relationship between psychological distress and infertility among couples. Furthermore, the investigators are interested in testing Dr. Alice Domar's Mind/Body Fertility Program that was designed to help individuals regain control of their life and learn new lifestyle habits that can increase their chances of conceiving. There is evidence that individuals that participated in the group format of this treatment protocol showed statistically significant decreases in physical and psychological symptoms of stress and increases in conception rates. Our primary goals are to evaluate patients willingness to be recruited and randomized as well as their adherence and attrition to the program. Our secondary goals are to evaluate reductions in emotional distress (i.e., anxiety, depression, and stress) and enhance emotion regulation skills as well as pregnancy rates.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Women and Men
• Infertility diagnosis
• Trying to get pregnant
• 18 years or older
• Read and write English

Exclusion Criteria:

• No current diagnosis for an active psychotic disorder, eating disorder, substance abuse or dependence
• Not reporting current suicidal ideation/intent
• No psychotropic medication changes in the last four weeks
• Has not completed a formal mind/body program focused on infertility that included relaxation, yoga, mindfulness, cognitive restructuring, stress reduction strategies, listening and communication skills, goal setting and assertiveness training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Online Mind/Body; Participants randomized to the intervention group (i.e., Online Mind/Body Program for Fertility) were provided the 10 online modules provided weekly (one module per week), intended to be completed over 10 weeks. Additionally, participants received weekly therapeutic feedback.	Behavioral: Online Mind/Body Program for Fertility; The Mind/Body intervention involves (1) reducing physical symptoms of stress, (2) enhancing lifestyle behaviors related to fertility, (4) self-nurturing and coping skills, and (5) relaxation methods.
No Intervention: Wait-List; After 10-weeks being in the wait-list group, participants had the potential to participate in the intervention protocol if they desire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility 1: Feasibility of recruitment and randomization	Number of participants recruited and randomized. From time study began to when recruitment closed.	Approximately 12 months
Feasibility 2: Time	Time between recruitment and completion of the study. Time between recruitment and randomization; time between each of the modules; time between each of the assessments (pre-assessment; mid-assessment; post-assessment, and follow-up).	Approximately 12 months
Feasibility 3: Participant retention and acceptability	Percentage of enrolled participants that completed each stage of the study (mid-assessment, post-assessment, follow-up, and each of the ten modules for the intervention group only).	Approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability 1: Ease of modules	Participants will be asked at the end of each module: "how easy was this module." Answer choices are on a 3-point Likert scale, ranging from 1 ("easy") to 3 ("not easy"). Data collected from beginning to end of intervention.	Approximately 12 months
Acceptability 2: Helpfulness	Participants will be asked at the end of each module: "how helpful was the module." Answer choices are on a four-item Likert scale ranging from 0 ("unhelpful") to 3 ("very helpful"). Data is collected throughout the Mind/Body program, intervention group only.	Approximately 12 months
Satisfaction of Intervention	Participant satisfaction as measured by the Client Satisfaction Inventory Short-Form (McMurtry & Hudson, 2000). This measurement is a 9-item self-report scale that assesses the satisfaction of the participant with the effects of the treatments. Participants are asked to rate the way they feel about the services they received on a 7-point Likert scale, ranging from 1 ("none of the time") to 7 ("all of the time"). The total scores range between 0 and 100 (for scoring algorithm, see McMurty & Hudson, 2000), with higher scores indicating more satisfaction. Data is collected for the intervention group at post-assessment only.	Approximately 12 months
Pregnancy: Between group comparison	Self-reported confirmation of pregnancy. Data collected at baseline, pre-assessment, mid-assessment, post-assessment, and follow-up.	Approximately 12 months
Anxiety 1: Individual changes	Individual changes in anxiety as measured by the Beck Anxiety Inventory. The Beck Anxiety Inventory is a 21-item self-report measure used to assess somatic or panic-related anxiety symptoms. Individuals are asked to rate their symptoms of anxiety over the past week on a 4-point Likert scale from 0 ("not at all") to 3 ("severely; I could barely stand it"). A total score is calculated by summing all items. Scores range from 0 (no anxiety severity) to 63 (severe anxiety severity). Data collected throughout study (baseline, pre-assessment, mid-assessment, post-assessment, and follow-up) as well as at the beginning of each intervention module.	Approximately 12 months
Anxiety 2: Between group changes	Between group changes in anxiety as measured by Beck Anxiety Inventory (Beck, Steer, Beck, & Newman, 1993). The Beck Anxiety Inventory is a 21-item self-report measure used to assess somatic or panic-related anxiety symptoms. Individuals are asked to rate their symptoms of anxiety over the past week on a 4-point Likert scale from 0 ("not at all") to 3 ("severely; I could barely stand it"). A total score is calculated by summing all items. Scores range from 0 (no anxiety severity) to 63 (severe anxiety severity). Data collected throughout study (baseline, pre-assessment, mid-assessment, post-assessment, and follow-up) as well as at the beginning of each intervention module.	Approximately 12 months
Depression 1: Individual changes	Individual changes in depression as measured by the Beck Depression Inventory - 2nd Edition. The Beck Depression Inventory - 2nd Edition is a 21-item self-report measure used to assess cognitive, affective, and physical depressive symptoms. Questions include content such as sadness, guilt, disappointment, and loss of energy. Participants are asked to rate each item on a 4-point Likert scale from 0 (not endorsed) to 3 (endorsed at maximum severity). A total score is calculated by summing all items. Scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Data collected at baseline, pre-assessment, mid-assessment, post-assessment and follow-up).	Approximately 12 months
Depression 2: Between group changes	Between group changes in depression as measured by the Beck Depression Inventory - 2nd Edition (Beck, Steer, Ball, & Ranieri, 1996). The Beck Depression Inventory - 2nd Edition is a 21-item self-report measure used to assess cognitive, affective, and physical depressive symptoms. Questions include content such as sadness, guilt, disappointment, and loss of energy. Participants are asked to rate each item on a 4-point Likert scale from 0 (not endorsed) to 3 (endorsed at maximum severity). A total score is calculated by summing all items. Scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Data collected at baseline, pre-assessment, mid-assessment, post-assessment and follow-up).	Approximately 12 months
Stress: Between group changes	Between group changes in stress as measured by Perceived Stress Scale. The Perceived Stress Scale is a 10-item questionnaire measuring the present level of self-rated stress in the last month. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate more distress. Participants are asked to rate each item on a 5-point Likert scale from 0 ("never") to 4 ("very often"). Scores range from 0 to 40 where higher scores indicate greater perceived stress (for scoring algorithm see Cohen, 1988; Cohen, Kamarck, & Mermelstein, 1983).	Approximately 12 months
Mindfulness: Between group comparison	Between group changes in mindfulness as measured by the Five-Factor Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). The FFMQ is a 39-item self-report measure used to assess a trait-like tendency to be mindful in daily life. It has five subscales (i.e., observe, describe, awareness, non-judgmental, and non-reactive). Each question on the FFMQ is rated on a 5-point Likert scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true"). Total score (adding subscale scores) ranges from 39 to 195 with higher scores indicating greater mindfulness (for scoring algorithm see Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). Data collected at baseline, mid-assessment, and post-assessment.	Approximately 12 months
Fertility Problem Inventory: Between group changes	Between group changes in fertility related distress as measured by The Fertility Problem Inventory. The Fertility Problem Inventory is a 46-item questionnaire that measures domains (Social Concern, Sexual Concern, Relationship Concern, Need for Parenthood, and Rejection of Child-Free Lifestyle) considered important in understanding perceived infertility related stress as well as an overall global index of infertility-related stress (composite score of the all domains). The overall score ranges from 46 to 276. For each of the scales, higher scores indicate more fertility related distress (for a scoring algorithm see Newton, Sherrard, & Glavac, 1999). Data collected at baseline, post-assessment, and follow-up.	Approximately 12 months
Emotion Regulation: Between group comparison	Between group changes in emotion regulation as measured by the Difficulties in Emotional Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS is a 36-item self-report questionnaire measuring problems with emotional regulation based on responses indicating impairment in six dimensions (Goals, Impulse, Awareness, Nonacceptance, Strategy, and Clarity) and a total score (sum of all subscales). Total score ranges from 36 to 180. For each of the scales, higher scores indicate greater difficulties with emotional regulation in each of the domains (for scoring algorithm see Gratz & Roemer, 2004). Data collected at baseline and post-assessment.	Approximately 12 months
Relationship Quality: Between group comparison	Between group changes in emotion regulation as measured by the Dyadic Adjustment Scale (Spanier, 1976). The Dyadic Adjustment Scale is a 32-item questionnaire assessing relationship difficulty in four domains (Consensus, Satisfaction, Affective Expression, and Cohesion) and a total score. The total score ranges form 0 and 151. Greater scores indicate greater marital satisfaction (for scoring algorithm see, Spanier, 1976). Data collected at baseline and post-assessment.	Approximately 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction 2: Qualitative	Open-ended questions regarding components of the mind/body program throughout the ten modules and post-intervention to provide context around satisfaction of intervention.	Approximately 12 Months

Collaborators and Investigators

• Sponsor: University of Vermont
• Investigators: Principal Investigator: Jessica Clifton, Ph.D., University of Vermont

Publications and helpful links

General Publications

• Domar AD, Clapp D, Slawsby EA, Dusek J, Kessel B, Freizinger M. Impact of group psychological interventions on pregnancy rates in infertile women. Fertil Steril. 2000 Apr;73(4):805-11. doi: 10.1016/s0015-0282(99)00493-8. Erratum In: Fertil Steril 2000 Jul;74(1):190.
• Domar AD, Clapp D, Slawsby E, Kessel B, Orav J, Freizinger M. The impact of group psychological interventions on distress in infertile women. Health Psychol. 2000 Nov;19(6):568-75. doi: 10.1037//0278-6133.19.6.568.
• Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.

Helpful Links

• Online Mind/Body Program for Fertility

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2015
• Primary Completion (Actual): April 14, 2017
• Study Completion (Actual): April 14, 2017

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Mind/Body
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: MindBody

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No