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

NCT02860910 | Completed DMC

• 1 other identifier: 04-16-11
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Major Depressive Disorder; Menopause

Keywords

hot flashes; postmenopause; perimenopause

Outcome Measures

Primary Outcomes (2)

• Number of participants who begin cognitive group behavioral therapy

  2 years

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

  Baseline and Week 6

Secondary Outcomes (2)

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

  Baseline and Week 6

• Change in Menopause Representation Questionnaire (MRQ) total score

  Baseline and Week 6

Study Arms (1)

Cognitive Behavioral Group Therapy

EXPERIMENTAL

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

Interventions

Cognitive Behavioral Group Therapy BEHAVIORAL

Cognitive Behavioral Group Therapy

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danette Conklin, PhD: lead

Study Sites (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• 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.

  PMID: 34671764 DERIVED

• 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.

  PMID: 31837624 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Major; Hot Flashes

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Danette Conklin, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Midlife Wellness for Woman

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: August 9, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)