Cognitive Behavioral Therapy for Menopause

Recruiting at 1 trial location

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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

Women are the fastest-growing group of U.S. Veterans. Over half of those using VA care are 45 or older, with more age-related health concerns than civilian women. The VA urgently needs gender-informed strategies to ensure women Veterans receive tailored care that addresses their intersecting mental, physical, and age related health concerns, as well as gender-linked stressors. One prominent example is menopause, a health transition period that, for many women, can be associated with negative physical and mental health concerns that can worsen their functioning and quality of life. This project will: (1) integrate stakeholder feedback to tailor Cognitive Behavioral Therapy for Menopause (CBT-Meno) for women Veterans with menopause concerns; and (2) refine and evaluate tailored CBT-Meno as a treatment to address these intersecting needs in a clinical trial.

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 data supports the effectiveness of the treatment Tailored Cognitive Behavioral Therapy for Menopause?

Research shows that cognitive behavioral therapy (CBT) can effectively reduce menopausal symptoms like hot flashes, improve sleep, and enhance quality of life. It has been found to be beneficial in various formats, including group sessions and self-help, and is recommended for managing anxiety and depression during menopause. ^{1 2 3 4 5}

Is cognitive behavioral therapy (CBT) safe for treating menopausal symptoms?

Cognitive behavioral therapy (CBT) is generally considered safe for treating menopausal symptoms, as it is a non-drug therapy that focuses on managing symptoms like hot flashes, stress, and sleep problems. It has been found acceptable to women and is recommended by health organizations for managing menopause-related issues. ^{1 2 3 6 7}

How is Tailored Cognitive Behavioral Therapy for Menopause different from other treatments for menopause?

Tailored Cognitive Behavioral Therapy for Menopause is unique because it focuses on managing menopausal symptoms like hot flashes, mood swings, and sleep problems through psychological techniques rather than medication. It is a brief therapy that can be delivered in various formats, such as group sessions, self-help books, or online, making it flexible and accessible for many women. ^{1 2 3 4 8}

Research Team

Haley Miles-McLean, PhD

Principal Investigator

Rehabilitation R&D Service, Baltimore, MD

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive therapy and behavior therapy for menopausal symptoms: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for menopausal symptoms. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for menopausal symptoms (CBT-Meno): a randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of the CBT-Meno protocol on menopause-specific beliefs, dysfunctional attitudes, and coping behaviors. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A behavioral group treatment program for menopausal hot flashes: results of a pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Menopausal hormone therapy (MHT): refining our understanding of MHT research, optimally applying results, and considering the future of MHT. [2012]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Risks, Benefits, and Treatment Modalities of Menopausal Hormone Therapy: Current Concepts. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Comparing the effects of face-to-face versus phone counseling based on cognitive-behavioral therapy for vasomotor symptoms in postmenopausal women: a randomized controlled trial. [2023]