Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

NCT ID: NCT03311880

Last Updated: 2021-05-25

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2019-12-20

Brief Summary

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The goal in this study is to evaluate the effectiveness of a cognitive remediation program that was designed specifically to address the concerns related to cognitive difficulties that are often reported among women in the menopausal transition. This cognitive remediation program has been created to provide our clients with an opportunity to learn more about the relation between menopause and cognitive function, to learn new strategies to enhance thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known to have a beneficial effect on mental functioning.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

There is no control group for this study. Therefore all participants receive the intervention.

Group Type EXPERIMENTAL

Cognitive remediation

Intervention Type BEHAVIORAL

Participants will be taught compensatory strategies for subjective cognitive impairment in addition to learning about lifestyle modifications that are known to be beneficial on cognition.

Interventions

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Cognitive remediation

Participants will be taught compensatory strategies for subjective cognitive impairment in addition to learning about lifestyle modifications that are known to be beneficial on cognition.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Currently in menopausal transition
* Subjective cognitive complaints
* Presence of vasomotor menopausal symptoms (i.e., hot flashes)

Exclusion Criteria

* Individuals with acute and severe depression
* Suicidal ideation
* Severe PTSD
* Psychosis
* Severe alcohol/substance use issues
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Elena Ballantyne

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Ballantyne EC, King JP, Green SM. Preliminary Support for a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study. Front Glob Womens Health. 2021 Dec 23;2:741539. doi: 10.3389/fgwh.2021.741539. eCollection 2021.

Reference Type DERIVED
PMID: 35005701 (View on PubMed)

Other Identifiers

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2950

Identifier Type: -

Identifier Source: org_study_id

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