Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

NCT03311880 | Completed

• 1 other identifier: 2950
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

Intervention

EXPERIMENTAL

There is no control group for this study. Therefore all participants receive the intervention.

Behavioral: Cognitive remediation

Interventions

Cognitive remediation BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently in menopausal transition
• Subjective cognitive complaints
• Presence of vasomotor menopausal symptoms (i.e., hot flashes)

You may not qualify if:

• Individuals with acute and severe depression
• Suicidal ideation
• Severe PTSD
• Psychosis
• Severe alcohol/substance use issues

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 35005701 DERIVED

MeSH Terms

Interventions

Cognitive Remediation

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 17, 2017
• Study Start: January 17, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)