Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Behavioral: Cognitive remediation

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • St. Joseph's Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in self-reported cognitive difficulties	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective distress	Self-reported levels of stress, anxiety and depressive symptoms using the Depression Anxiety Stress Scale (DASS)	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	hot flashes measured by the Hot Flash Interference Scale	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	perfectionistic beliefs about cognitive performance, and beliefs about the relation between aging, menopause and cognition using Likert scales for items generated by team consensus	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.

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No