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Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders (Conklin MWW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02860910
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : September 30, 2019
Information provided by (Responsible Party):
Danette Conklin, PhD, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Major Depressive Disorder Menopause Behavioral: Cognitive Behavioral Group Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

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)

Behavioral: Cognitive Behavioral Group Therapy

Primary Outcome Measures :
  1. Number of participants who begin cognitive group behavioral therapy [ Time Frame: 2 years ]
  2. Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score [ Time Frame: Baseline and Week 6 ]

Secondary Outcome Measures :
  1. Change in Hot Flash Daily Interference Scale (HFRDIS) total score [ Time Frame: Baseline and Week 6 ]
  2. Change in Menopause Representation Questionnaire (MRQ) total score [ Time Frame: Baseline and Week 6 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02860910

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United States, Ohio
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Danette Conklin, PhD
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Principal Investigator: Danette Conklin, PhD University Hospitals Cleveland Medical Center
  Study Documents (Full-Text)

Documents provided by Danette Conklin, PhD, University Hospitals Cleveland Medical Center:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Danette Conklin, PhD, Director of Midlife Wellness for Woman, University Hospitals Cleveland Medical Center Identifier: NCT02860910    
Other Study ID Numbers: 04-16-11
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Danette Conklin, PhD, University Hospitals Cleveland Medical Center:
hot flashes
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Mood Disorders
Mental Disorders
Bipolar and Related Disorders