Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

Study Overview
=================
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.

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

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Behavioral: Cognitive remediation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>There is no control group for this study. Therefore all participants receive the intervention. | Behavioral: Cognitive remediation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |