Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

Not Applicable

Completed

• Conditions: Menopause
• Interventions: Behavioral: Cognitive remediation

• Registration Number: NCT03311880
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-01-17
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Cognitive remediation	There is no control group for this study. Therefore all participants receive the intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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

Trial Locations

Locations (1)

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada