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

September 25, 2019 updated by: Danette Conklin, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center - Mood Disorders Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Behavioral: Cognitive Behavioral Group Therapy

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

This is where you will find people and organizations involved with this study.

Sponsor

Danette Conklin, PhD

Investigators

  • Principal Investigator: Danette Conklin, PhD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

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)?

NO

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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