Back to results

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

Primary Purpose

Bipolar Disorder, Major Depressive Disorder, Menopause

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Group Therapy

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring hot flashes, postmenopause, perimenopause

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University Hospitals Cleveland Medical Center - Mood Disorders Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Group Therapy

Arm Description

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)

Outcomes

Primary Outcome Measures

Number of participants who begin cognitive group behavioral therapy

Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score

Secondary Outcome Measures

Change in Hot Flash Daily Interference Scale (HFRDIS) total score

Change in Menopause Representation Questionnaire (MRQ) total score

Full Information

NCT ID

NCT02860910

First Posted

June 14, 2016

Last Updated

September 25, 2019

Sponsor

Danette Conklin, PhD

1. Study Identification

Unique Protocol Identification Number

NCT02860910

Brief Title

Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders

Acronym

Conklin MWW

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Danette Conklin, PhD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder, Major Depressive Disorder, Menopause

Keywords

hot flashes, postmenopause, perimenopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Group Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Group Therapy

Primary Outcome Measure Information:

Title

Number of participants who begin cognitive group behavioral therapy

Time Frame

2 years

Title

Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score

Time Frame

Baseline and Week 6

Secondary Outcome Measure Information:

Title

Change in Hot Flash Daily Interference Scale (HFRDIS) total score

Time Frame

Baseline and Week 6

Title

Change in Menopause Representation Questionnaire (MRQ) total score

Time Frame

Baseline and Week 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danette Conklin, PhD

Organizational Affiliation

University Hospitals Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Cleveland Medical Center - Mood Disorders Program

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34671764

Citation

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.

Results Reference

derived

PubMed Identifier

31837624

Citation

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.

Results Reference

derived

Learn more about this trial

Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders

We'll reach out to this number within 24 hrs