- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02860910
Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders (Conklin MWW)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center - Mood Disorders Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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.
- Unwilling or unable to comply to study requirements.
- Women diagnosed with schizophrenia, schizoaffective, borderline personality disorder, and/or active psychosis, as confirmed by MINI.
- Diagnosed with active substance use disorder within past 12 months as confirmed on the MINI.
- Women currently treated with hormone therapy (HT) for Vasomotor Symptoms (VMS).
- Diagnosed with current post-traumatic stress disorder (PTSD).
- Participants experiencing acute mania as defined by a Young Mania Rating Scale (YMRS) score > 15
- Serious suicidal risks judged by the investigator or having score equal or greater than 4 on MADRS item number 10 at screening or baseline.
- Participants being treated with chemotherapy and/or tamoxifen.
- Women who are not self-identifying as either African-American or Caucasian.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cognitive Behavioral Group Therapy
The six CBGT sessions are outlined in the manual entitled: Managing Hot Flushes with Group Cognitive Behaviour Therapy: An Evidenced-Based Treatment Manual for Health Care Professionals (Hunter & Smith, 2015) as follows: Session 1: Psycho-education and the cognitive behavioural model Session 2: Stress management, improving wellbeing and identifying precipitants Session 3: Managing hot flushes using a cognitive behavioural approach Session 4: Managing night sweats and improving sleep (part one) Session 5: Managing night sweats and improving sleep (part two) Session 6: Review and maintaining changes (One alteration: Open discussion about mood disorders, anxiety and the psychological impact instead of the psychological impact of breast cancer) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who begin cognitive group behavioral therapy
Time Frame: 2 years
|
2 years
|
Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score
Time Frame: Baseline and Week 6
|
Baseline and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Hot Flash Daily Interference Scale (HFRDIS) total score
Time Frame: Baseline and Week 6
|
Baseline and Week 6
|
Change in Menopause Representation Questionnaire (MRQ) total score
Time Frame: Baseline and Week 6
|
Baseline and Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danette Conklin, PhD, University Hospitals Cleveland Medical Center
Publications and helpful links
General Publications
- Conklin D, Carpenter JS, Whitney MS, DeLozier S, Ogede DO, Bazella C, McVoy M, Sajatovic M. Narrative Analyses: Cognitive Behavior Group Therapy for Women with Menopause and Bipolar or Major Depressive Disorders. Womens Health Rep (New Rochelle). 2021 Sep 22;2(1):430-442. doi: 10.1089/whr.2021.0025. eCollection 2021.
- Conklin DY, Goto T, Ganocy S, Loue S, LaGrotta C, Delozier S, Brownrigg B, Conroy C, D'Arcangelo N, Janes J, Ogede D, Sajatovic M. Manualized cognitive behavioral group therapy to treat vasomotor symptoms for women diagnosed with mood disorders. J Psychosom Res. 2020 Jan;128:109882. doi: 10.1016/j.jpsychores.2019.109882. Epub 2019 Nov 20.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-16-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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