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Clinical Trials/NCT03311880
NCT03311880
Completed
N/A

Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study

St. Joseph's Healthcare Hamilton1 site in 1 country27 target enrollmentJanuary 17, 2018
ConditionsMenopause

Overview

Phase
N/A
Intervention
Not specified
Conditions
Menopause
Sponsor
St. Joseph's Healthcare Hamilton
Enrollment
27
Locations
1
Primary Endpoint
change in self-reported cognitive difficulties
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 17, 2018
End Date
December 20, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Ballantyne

Principal Investigator

St. Joseph's Healthcare Hamilton

Eligibility Criteria

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

Outcomes

Primary Outcomes

change in self-reported cognitive difficulties

Time Frame: At the beginning of the first session and at the conclusion of the 5th session to assess change over time. That means measures will be administered 5 weeks later.

beliefs about general memory abilities, confidence in decision-making abilities, confidence in one's ability to focus or concentrate, and high standards regarding one's cognitive performance using the Memory and Cognitive Confidence Scale (MACCS)

Secondary Outcomes

  • Subjective distress(At the beginning of the first session and at the conclusion of the 5th session to assess change over time. That means measures will be administered 5 weeks later.)
  • Vasomotor symptoms(At the beginning of the first session and at the conclusion of the 5th session to assess for change over time. That means measures will be administered 5 weeks later.)
  • Beliefs(At the beginning of the first session and at the conclusion of the 5th session to assess for change over time. That means measures will be administered 5 weeks later.)

Study Sites (1)

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