Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The Beck Depression Inventory
研究概览
简要总结
This study examined the effectiveness of a new cognitive-behavioural therapy for menopausal symptoms (CBT-Meno). Half of participants were randomly assigned to the 12-week CBT-Meno program and half to a 12-week waitlist. Common menopause symptoms (i.e., hot flashes/night sweats, depression, anxiety, poor sleep, and sexual concerns) were assessed at baseline, 12-weeks post-baseline, and (for women in the CBT-Meno condition) at 3-month follow-up.
详细描述
Women going through the menopausal transition often experience adverse physical changes (e.g., hot flashes/night sweats, sleep difficulties, sexual concerns) in addition to emotional difficulties (e.g., depression, anxiety) that can significantly impact functioning and overall quality of life. To date, hormone therapy (HT) has been the most commonly used treatment to relieve symptoms of menopause. However, reports have questioned the safety of HT long-term (e.g., risk of heart attacks, strokes, cancer) for some women. Cognitive-behavioural therapy (CBT), has been proposed as a low-risk treatment for menopausal symptoms. The investigators developed a comprehensive non-pharmacological, CBT for menopausal symptoms (CBT-Meno), published the treatment manual (Green, McCabe, & Soares, 2012), and obtained initial evidence supporting the effectiveness of CBT-Meno in a single-sample pilot study (Green et al., 2013). The goal in the study reported here was to conduct a larger randomized controlled trial to evaluate the effectiveness of the CBT-Meno program compared to a waitlist condition. The investigators hypothesized that participants would experience less intense/disruptive hot flashes/night sweats, reduced depression and anxiety, improvement in sleep difficulties, and sexual concerns. The investigators also predicted that these benefits would be maintained at 3-month follow-up and that participants would report high treatment satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors evaluated symptoms at baseline, 12-weeks post-baseline, and 3-month follow-up. Assessors were unaware of participants' assigned condition.
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
- 否
入选标准
- •Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
- •A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
- •Significant vasomotor symptoms: i.e., vasomotor symptoms that are (a) frequent (≥ 4 hot flashes per day/night or 21 or more per week); (b) distressing (≥ 3 or more on the vasomotor subscale of the Greene Climacteric Scale); and (c) interfering (≥ 30 or greater on the Hot Flash Related Daily Interference Scale).
- •Not taking hormonal, anti-depressant, or any herbal therapies or if taking these medications they must be taking a stable dose for at least three months prior to the study and for the duration of the study,
- •Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.
排除标准
- •Participants who are severely depressed/suicidal at the time of the screen or intake assessment that would warrant acute treatment and hence, render them unable to act as a wait list control participant if randomized to this condition,
- •Participants with Psychotic Disorders, or current Substance Dependence.
研究组 & 干预措施
Experimental Group (CBT-Meno)
After an initial assessment, the experimental group received 12 weekly sessions (2 hours each) of group-based cognitive-behavioural therapy for menopausal symptoms (CBT-Meno) (up to n=8 per group). Symptoms that were targeted included vasomotor symptoms (hot flashes/night sweats), depressive symptoms, anxiety, poor sleep, and sexual concerns. Participants were re-assessed at 12-weeks post-baseline and at 3 months post-treatment.
干预措施: CBT for Menopausal Symptoms (CBT-Meno) (Other)
Waitlist
After an initial assessment, the waitlist comparison group did not receive any treatment for 12 weeks. They were then re-assessed at 12-weeks post-baseline and this data was used to compare this group to the experimental group to determine the effectiveness of the CBT-Meno treatment. After this re-assessment participants in the waitlist condition were offered the same CBT-Meno treatment as the experimental group: 12 weekly sessions (2 hours long) of cognitive-behavioural therapy for menopausal symptoms.
结局指标
主要结局
The Beck Depression Inventory
时间窗: 12 weeks
The Beck Depression Inventory is a multiple choice questionnaire which measures depressive symptoms (Beck, Steer \& Brown, 1996). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces subjective depressive symptoms, compared to pre-treatment and wait-list controls.
The Hot Flash Related Daily Interference Scale
时间窗: 12 weeks
The Hot Flash Related Daily Interference Scale assesses the degree to which vasomotor functions interfere with daily life (Carpenter, 2001). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces vasomotor function daily interference, as captured by the Hot Flash Related Daily Interference Scale, compared to pre-treatment and wait-list controls.
次要结局
- The Hamilton Anxiety Scale(12 weeks)
- Ambulatory Sternal Skin-Conductance Monitoring(12 weeks)
- Female Sexual Functioning Index(12 weeks)
- The Greene Climacteric Scale - Sexual Concerns(12 weeks)
- Depression Anxiety Stress Scale (DASS)(12 weeks)
- Born Steiner Irritability Scale(12 weeks)
- Menopause Representation Questionnaire (MRQ)(12 weeks)
- Couples Satisfaction Index (CSI-32)(12 weeks)
- The Greene Climacteric Scale - Vasomotor Subscale(12 weeks)
- The Montgomery-Asberg Depression Rating Scale(12 weeks)
- Clinical Global Impression Scale (CGI)(12 weeks)
- Hot Flash Behaviour Scale (HFBehS)(12 weeks)
- Anxiety Sensitivity Index-3 (ASI-3)(12 weeks)
- The Pittsburgh Sleep Quality Inventory(12 weeks)
- Beck Anxiety Inventory (BAI)(12 weeks)
- The Utian Quality of Life Scale(12 weeks)
- Dysfunctional Attitudes Scale (DAS)(12 weeks)
- Hot Flash Rating Scale: Frequency & Problem Rating Scale (HFRS-FP)(12 weeks)
- Hot Flash Belief Scale (HFBS)(12 weeks)
- Client Satisfaction Questionnaire (CSQ)(12 weeks)
研究者
Sheryl Green
Clinical Health Psychologist
St. Joseph's Healthcare Hamilton