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Completed

NCT Number: NCT03311880

Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

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.

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Key information

Conditions

Menopause

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. change in self-reported cognitive difficulties

    Time frame: 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 outcomes

  1. Subjective distress

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 17, 2017
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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