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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03311880
Enrollment
27
Registered
2017-10-17
Start date
2018-01-17
Completion date
2019-12-20
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change in self-reported cognitive difficultiesAt 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

MeasureTime frameDescription
Subjective distressAt 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 symptomsAt 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
BeliefsAt 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026