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Online Mind/Body Program for Fertility

NCT ID: NCT03343405

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-14

Study Completion Date

2017-04-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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Mind/Body

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A between groups repeated measure experimental design. Participants that met inclusion criteria and were interested in continuing with the study were randomized to either the treatment or wait-list group. Participants randomized to the treatment group were provided with 10 online program modules provided weekly over 10 weeks. After 10-weeks the wait-list group had the opportunity to participate in the intervention protocol if they desire. All participants will be asked to complete pre-, mid-, post-, f/u- intervention questionnaires.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Online Mind/Body Program for Fertility

Intervention Type BEHAVIORAL

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.

Wait-List

After 10-weeks being in the wait-list group, participants had the potential to participate in the intervention protocol if they desire.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Jessica Clifton

Post-Doctoral Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Clifton, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 10731544 (View on PubMed)

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.

Reference Type RESULT
PMID: 11129360 (View on PubMed)

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.

Reference Type RESULT
PMID: 21496800 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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MindBody

Identifier Type: -

Identifier Source: org_study_id