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Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

Sponsor
St. Joseph's Healthcare Hamilton (Other)
Overall Status
Completed
CT.gov ID
NCT03311880
Collaborator
(none)
27
Enrollment
1
Location
1
Arm
23.1
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Cognitive remediation
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 17, 2018
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. change in self-reported cognitive difficulties [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 [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 [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 [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

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 St. Joseph's Healthcare Hamilton Ontario Canada

Sponsors and Collaborators

  • St. Joseph's Healthcare Hamilton

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Ballantyne, Principal Investigator, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT03311880
Other Study ID Numbers:
  • 2950
First Posted:
Oct 17, 2017
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 25, 2021