Cognitive Behavioral Therapy for Menopause

Not yet recruiting at 2 trial locations

Overseen By Haley Miles-McLean, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Prior CBT-Meno, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Cognitive Behavioral Therapy (CBT) can help women Veterans manage menopause symptoms. Menopause often presents physical and mental challenges that impact daily life and well-being. The treatment, called CBT-Meno, adapts traditional CBT to meet the specific needs of women Veterans. Women aged 45 or older, receiving care from the VA Maryland Healthcare System, and experiencing moderate menopause symptoms might be suitable for this trial. As an unphased trial, participants contribute to pioneering research that may enhance menopause care for women Veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this therapy is safe for menopause treatment?

Research shows that Cognitive Behavioral Therapy (CBT) safely treats menopause symptoms. Studies have found that CBT reduces symptoms like hot flashes and improves quality of life without major side effects. For instance, one study found CBT effective for managing hot flashes in women of various ages and stages of menopause.

Another study found that CBT improved sexual health for women experiencing menopause. These benefits occurred without serious negative effects, indicating that the therapy is generally well-tolerated. Thus, while CBT is not a medication, it is considered a safe method for managing menopause issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Tailored Cognitive Behavioral Therapy for Menopause (CBT-Meno) is unique because it specifically addresses menopause symptoms through a personalized approach designed for women Veterans. Unlike hormone replacement therapy, which is a common standard treatment, this therapy offers a non-pharmacological option that combines psychoeducation with cognitive and behavioral strategies. Researchers are excited about CBT-Meno because it leverages insights from preliminary studies and expert input to better meet the needs of this specific population, potentially offering a more effective and tailored solution for managing menopause symptoms.

What evidence suggests that this therapy might be an effective treatment for menopause?

Studies have shown that Cognitive Behavioral Therapy for Menopause (CBT-Meno), which participants in this trial will receive, effectively manages menopause symptoms. Research indicates that CBT-Meno reduces common symptoms like hot flashes and night sweats. It also improves mood by alleviating depression and aids with sleep and sexual health issues. A review of studies found that CBT has a moderate effect on treating menopausal symptoms. Overall, CBT-Meno supports a better quality of life for women experiencing menopause. ^{1 2 4 6 7}

Who Is on the Research Team?

Haley Miles-McLean, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for aging women veterans dealing with menopause. Participants should be seeking care through the VA and are experiencing negative impacts on their mental or physical health due to menopause.

Inclusion Criteria

I am female.

I experience moderate to severe menopause symptoms.

I can attend appointments via video or phone.

Exclusion Criteria

I have participated in cognitive behavioral therapy for menopause.

Engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by chart review)

Participated in Aim 1 as a Veteran stakeholder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-pilot Group

Initial acceptability of tailored CBT-Meno is examined through a pre-pilot group with women Veterans with menopause concerns.

Approximately 12 weeks

Multiple sessions (virtual)

Single-arm Pilot Trial

Tailored CBT-Meno is tested in a single-arm pilot trial to assess feasibility, acceptability, fidelity, and preliminary efficacy.

Approximately 2 years

Multiple sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

Approximately 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Cognitive Behavioral Therapy for Menopause

Trial Overview The study tests a specialized Cognitive Behavioral Therapy tailored for menopausal symptoms (CBT-Meno) in women veterans, aiming to improve their functioning and quality of life by addressing both mental and physical health concerns.

How Is the Trial Designed?

Group I: Tailored CBT-Meno Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy for Menopause (CBT-Meno) is an evidenced-based intervention that includes psychoeducation, cognitive, and behavioral strategies for coping with common menopause symptoms and experiences. In Aims 1 and 2, CBT-Meno materials and procedures will be tailored for women Veterans through an iterative process involving: a) data from preliminary studies and a pre-pilot trial; b) input from content area experts; and c) stakeholder advisory panels. This tailored version of CBT-Meno will then be test in this clinical trial.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Cognitive-behavioral group treatment (CBGT) was moderately effective in reducing the frequency of hot flashes and night sweats in a pilot study of 19 menopausal women over 8 weekly sessions.

While there were improvements in psychosocial functioning, these were not statistically significant, suggesting that CBGT may still offer benefits for managing vasomotor symptoms in menopause despite the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral group treatment program for menopausal hot flashes: results of a pilot study. Keefer, L., Blanchard, EB.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31453958/

Cognitive behavior therapy for menopausal symptoms ... CBT-Meno was particularly effective in improving self-reported vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512224001981

Efficacy of cognitive behavioral therapy for menopausal ... A systematic review and meta-analysis show that cognitive and behavioral therapies (CBT) for menopausal symptoms have moderate effects [9]. CBT has been ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02480192

Cognitive Behavioural Therapy for Menopausal Symptoms The current study aims to explore whether CBGT for menopausal symptoms significantly improves quality of life compared to pre-treatment and wait list controls.

4. womensmentalhealth.org womensmentalhealth.org/posts/cbt-effective-menopausal-vasomotor-symptoms/

CBT is Effective for Menopausal Vasomotor Symptoms CBT was effective for reducing complaints of vasomotor symptoms regardless of age, body mass index, menopause status, or psychological factors at baseline.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/n/niceng23er1/

Cognitive behavioural therapy - NCBI Bookshelf - NIH This review will look at the effectiveness of cognitive behavioural therapy for managing symptoms associated with the menopause.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525009388

A randomized controlled trial comparing mobile-app-based ... Multiple studies indicate that CBT is an effective therapeutic method for alleviating menopausal symptoms in both the general population and breast cancer ...

7. academic.oup.com academic.oup.com/jsm/article-abstract/22/7/1184/8136438

Cognitive behavioural therapy for sexual concerns during ... Results suggest that CBT-SC-Meno leads to significant improvements in sexual functioning across several important sexual concern domains and ...