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临床试验/NCT02860910
NCT02860910已完成不适用

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

Danette Conklin, PhD2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
2
主要终点
Number of participants who begin cognitive group behavioral therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

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)

干预措施: Cognitive Behavioral Group Therapy (Behavioral)

结局指标

主要结局

Number of participants who begin cognitive group behavioral therapy

时间窗: 2 years

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

时间窗: Baseline and Week 6

次要结局

  • Change in Menopause Representation Questionnaire (MRQ) total score(Baseline and Week 6)
  • Change in Hot Flash Daily Interference Scale (HFRDIS) total score(Baseline and Week 6)

研究者

发起方
Danette Conklin, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Danette Conklin, PhD

Director of Midlife Wellness for Woman

University Hospitals Cleveland Medical Center

研究点 (2)

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