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

Sponsor

Danette Conklin, PhD (Other)

Overall Status

Completed

CT.gov ID

NCT02860910

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder Major Depressive Disorder Menopause	Behavioral: Cognitive Behavioral Group Therapy	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2016

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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.