Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311880
• Other study ID #: 2950
• Status: Completed
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: May 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.