A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility

NCT ID: NCT05903638

Last Updated: 2023-06-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-09-30

Brief Summary

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We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.

Detailed Description

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Conditions

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Primary Infertility Mental Health Issue Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual Mindfulness-Based Stress Reduction (MBSR) program

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction course

Intervention Type BEHAVIORAL

8-week, 26-hour, virtual mindfulness course

Interventions

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Mindfulness-Based Stress Reduction course

8-week, 26-hour, virtual mindfulness course

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR

Eligibility Criteria

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Inclusion Criteria

-Primary infertility and no prior fertility treatment

Exclusion Criteria

* No internet access
* Non-English speaking
* History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
* Psychotropic medication change in the previous month
* Previously seen at another fertility clinic
* Previous MBSR course
* Previous mindfulness meditation retreat
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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One Fertility

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehrnoosh Faghih, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, ONE Fertility

Locations

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ONE Fertility

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MBSR Pilot RCT

Identifier Type: -

Identifier Source: org_study_id

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