A Pilot RCT: the Impact of a Virtual MBSR Course on Women... | NCT05903638

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

NCT05903638

Sponsor

One Fertility

Status

Unknown status

Last Update Posted

Jun 15, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Primary Infertility
Mental Health Issue
Quality of Life

Interventions

Mindfulness-Based Stress Reduction course

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Jun 5, 2023

First Submission Date that Met QC Criteria

Jun 5, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2023

Last Update Posted Date

Jun 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention
Virtual Mindfulness-Based Stress Reduction (MBSR) program	Experimental		Behavioral: Mindfulness-Based Stress Reduction course

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Stress Reduction course	Behavioral	8-week, 26-hour, virtual mindfulness course	Virtual Mindfulness-Based Stress Reduction (MBSR) program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MBSR course participation rate		8-weeks of MBSR course
Survey completion rate		Randomization to 3-months after course completion

Secondary Outcomes

Measure	Description	Time Frame
Beck Depression Inventory		Randomization to 3-months after course completion
Beck Anxiety Inventory		Randomization to 3-months after course completion
Perceived Stress Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehrnoosh Faghih, MD	McMaster University, ONE Fertility	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ONE Fertility		Hamilton	Ontario	L7N 3T1	Canada