Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders

Major Depressive Disorder Clinical Trial

— Conklin MWW  

Official title:

Cross-Cultural Cognitive Behavioral Group Therapy: Evaluating the Effectiveness of a Manualized Cognitive Behavior Group Therapy Treatment for the Management of Menopause Symptoms in a Mood and Anxiety Disorder Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860910
• Other study ID #: 04-16-11
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2019
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The general objective of this study is to advance insight into non-pharmacological treatments for maturing women that impact psychological health and wellbeing of women adapting to menopause, a natural but often challenging developmental milestone.

Description:

This exploratory study proposes to expand the knowledge in the menopausal literature and evaluate the effectiveness of cognitive-behavioral group therapy (CBGT) in reducing problematic vasomotor symptoms, reducing daily interference and improving quality of life. The study will include two homogenous peri- or post-menopausal cohorts (African-American and Caucasian) with major depressive disorder or bipolar disorder. The intervention will be delivered in groups of 6 to 10 participants per group of both race/ethnicities in an outpatient setting during a 6-week time period. The participants will be assessed on the degree of hot flash problem rating, hot flash related daily interference, and menopause quality of life at screening, baseline, and post-treatment. Participants will also be assessed using the following predictor variables at the same time points: body mass index (BMI), level of perceived stress, severity of depression, severity of anxiety level of pleasure, severity of mania, hot flash beliefs and severity of couple's conflict.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria.

1. Self-identified as African-American or Caucasian females between 40-65 experiencing the early, late peri-menopause or early or late post-menopause stages of reproductive aging defined by The North American Menopause Society (NAMS, 2014), Menopause Practice guidelines, stages of reproductive aging. There are situations in which menopause status will not be able to be determined, such as with women who have had a hysterectomy. However, if the potential study participant meets all other inclusion criteria, then she can be enrolled in the study.

2. Diagnosed with current or lifetime bipolar disorder or major depressive disorder as assessed by the MINI International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual-5 (DSM-5).

3. Menopause symptoms can be natural or surgically induced.

4. Willing to remain on current dose of psychotropic medications until the study has concluded.

5. Experiencing one or more hot flashes and/or night sweats per day.

6. Willing to have the 6 CBGT interventions audio recorded.

7. English speaking with at least a high school education.

8. Montgomery-Asberg Depression Rating Scale (MADRS) total score > 7

9. Women stable on psychotropic medications for = 8 weeks.

Medication regimens to treat their DSM-V diagnoses will be encouraged to continue in order to determine if the CBGT accounted for any change in symptoms.

Exclusion Criteria.

1. Unwilling or unable to comply to study requirements.

2. Women diagnosed with schizophrenia, schizoaffective, borderline personality disorder, and/or active psychosis, as confirmed by MINI.

3. Diagnosed with active substance use disorder within past 12 months as confirmed on the MINI.

4. Women currently treated with hormone therapy (HT) for Vasomotor Symptoms (VMS).

5. Diagnosed with current post-traumatic stress disorder (PTSD).

6. Participants experiencing acute mania as defined by a Young Mania Rating Scale (YMRS) score > 15

7. Serious suicidal risks judged by the investigator or having score equal or greater than 4 on MADRS item number 10 at screening or baseline.

8. Participants being treated with chemotherapy and/or tamoxifen.

9. Women who are not self-identifying as either African-American or Caucasian.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Menopause

Intervention

Behavioral:
• Cognitive Behavioral Group Therapy

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center - Mood Disorders Program	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Danette Conklin, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who begin cognitive group behavioral therapy		2 years
Primary	Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score		Baseline and Week 6
Secondary	Change in Hot Flash Daily Interference Scale (HFRDIS) total score		Baseline and Week 6
Secondary	Change in Menopause Representation Questionnaire (MRQ) total score		Baseline and Week 6