Bipolar Disorder, Major Depressive Disorder, Menopause
Conditions
Keywords
hot flashes, postmenopause, perimenopause
Brief 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.
Detailed 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.
Interventions
BEHAVIORALCognitive Behavioral Group Therapy
Sponsors
Danette Conklin, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who begin cognitive group behavioral therapy | 2 years |
| Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score | Baseline and Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hot Flash Daily Interference Scale (HFRDIS) total score | Baseline and Week 6 |
| Change in Menopause Representation Questionnaire (MRQ) total score | Baseline and Week 6 |
Countries
United States
Outcome results
None listed