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Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03311880
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Elena Ballantyne, St. Joseph's Healthcare Hamilton

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Behavioral: Cognitive remediation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
There is no control group for this study. Therefore all participants receive the intervention.
 Behavioral: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Subjective distress [ 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. ]
    Self-reported levels of stress, anxiety and depressive symptoms using the Depression Anxiety Stress Scale (DASS)

  2. Vasomotor symptoms [ Time Frame: 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. ]
    hot flashes measured by the Hot Flash Interference Scale

  3. Beliefs [ Time Frame: 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. ]
    perfectionistic beliefs about cognitive performance, and beliefs about the relation between aging, menopause and cognition using Likert scales for items generated by team consensus


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311880


Locations
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Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elena Ballantyne, Principal Investigator, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT03311880    
Other Study ID Numbers: 2950
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No