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

NCT ID: NCT02860910

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-10-31

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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Menopause

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Cognitive Behavioral Group Therapy

Intervention Type: BEHAVIORAL

Interventions

Cognitive Behavioral Group Therapy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Danette Conklin, PhD

OTHER

Sponsor Role: lead

Responsible Party

Danette Conklin, PhD

Director of Midlife Wellness for Woman

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Danette Conklin, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34671764 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31837624 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

04-16-11

Identifier Type: -

Identifier Source: org_study_id