Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders (NCT02860910) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders
United States59 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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.
✓. 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).
✓. Menopause symptoms can be natural or surgically induced.
✓. Willing to remain on current dose of psychotropic medications until the study has concluded.
✓. Experiencing one or more hot flashes and/or night sweats per day.
✓. Willing to have the 6 CBGT interventions audio recorded.
✓. English speaking with at least a high school education.
✓. Montgomery-Asberg Depression Rating Scale (MADRS) total score \> 7
Exclusion criteria
✕. Unwilling or unable to comply to study requirements.
✕. Women diagnosed with schizophrenia, schizoaffective, borderline personality disorder, and/or active psychosis, as confirmed by MINI.
What they're measuring
1
Number of participants who begin cognitive group behavioral therapy
Timeframe: 2 years
2
Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score