Is cognitive behaviour therapy an effective option for women who have troublesome menopausal symptoms?

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report more neutral or positive changes, for example, not having menstrual periods (Brown, Brown, Judd, & Bryant, 2018;Hvas, 2006;Smith, Mann, Mirza, & Hunter, 2011). Social attitudes may in turn influence an individual woman's views about menopause, as well as her appraisal of VMS (Rendall, Simmons, & Hunter, 2008). We have found that negative beliefs and appraisals of VMS and behavioural avoidance (e.g., avoiding social situations) were significantly associated with more problematic VMS (Hunter, Ayers, & Smith, 2011;Rendall et al., 2008;Reynolds, 2000). The three main types of negative beliefs and appraisals of VMS are: 1. Beliefs about hot flushes in a social context, 'they are embarrassing and shameful', 2. Perceived control over hot flushes, 'They will never end, I can't cope', and 3. Beliefs about night sweats and sleep, 'If I wake I'll never get back to sleep', 'if I have night sweats I'll feel terrible the next day'.
Women often report that VMS symptoms are more difficult to deal with while at work, due to embarrassment and worry about the reactions of others (Griffiths & Hunter, 2015). Not surprisingly, if women think that they are viewed as 'unattractive, old, or useless'thoughts which are associated with unduly negative stereotypes about menopause in generalthey are more likely to feel distressed. Having to hide signs of menopause is often mentioned as an additional source of anxiety when at work. Certain situations at work can precipitate or exacerbate hot flushes such as work stress, high visibility tasks such as presentations, uniforms, and hot and poorly ventilated environments (Hardy, Griffiths, Norton, & Hunter, 2018;Hardy, Thorne, Griffiths, & Hunter, 2018).
Based on this research, Hunter and Mann (2010) developed a theoretical model of VMS that draws upon symptom perception, self-regulation, and cognitive behavioural theories to explain women's perceptions, appraisals, and reactions to VMS symptoms ( Figure 1). The model includes the influence of concurrent stress, mood, negative beliefs, and behaviours. Internal and external factors, such as anxiety, spicy food, and alcohol, can trigger hot flushes, while attentional focus on bodily sensations (somatic amplification) is associated with VMS reporting. Cognitive reactions can exacerbate distress and VMS, for example, negative beliefs about menopause and VMS (relating to social embarrassment, disgust, feeling out of control and worry about sleep) and behavioural reactions, such as avoiding social situations, are associated with more problematic VMS. We tested the model by investigating the relationships between perceived stress, mood, VMS beliefs and subjective and physiological measures of menopausal VMS (Hunter & Chilcot, 2013). Over half (53.2%) of the variance in VMS problem rating could be explained; with stress, anxiety, and somatic amplification predicting VMS problem rating, but only via their impact on VMS beliefs. These findings support the CBT model at the level of symptom perception and cognitive appraisal.
The MENOS CBT treatment protocol was based on this model, being interactive and educational, with a focus on helping people to reduce stress, to manage hot flushes and night sweats, and improve sleep . Relationships between physical symptoms, cognitions (thoughts and beliefs), feelings and behavioural reactions are examined, using educational PowerPoint slides, group discussion, handouts, and homework to be worked on between sessions. Negative beliefs about hot flushes in social contexts, such as 'everyone is looking at me', can lead to feelings of shame and embarrassment and increased physiological arousal, which in turn increases hot flush intensity. Women might then wish to leave or avoid situations believing that they are unable to cope. The intervention aims to counter these negative cycles using a range of strategies to help women to deal with stress, VMS, and sleep problems. In summary, the sessions include: Information about menopause and VMS with physiological explanation and introduction to the cognitive behavioural model Identifying individual goals Monitoring and modifying hot flush triggers or precipitants CBT to reduce stress and improve well-being, including diaphragmatic breathing exercise Exploring the impact of unhelpful cognitions (thoughts, beliefs, and attitudes) relating to menopause, ageing, and VMS, and encouraging supportive alternatives Encouraging helpful behavioural strategies, for example, reducing avoidance, pacing activities Information and CBT strategies for managing night sweats and sleep Maintenance plans.
The group CBT treatment targets are worked on over 4 or 6 weekly sessions comprising 8 hr in total and were delivered by a clinical health psychologist in the MENOS trials. Self-help CBT involves a booklet and audio with up to 1.5 hr of telephone guidance, with the same content as group CBT, followed over 4 weeks. Goals are agreed at the outset, and individualized homework is carried out between sessions. The final session includes a review and maintenance plan to encourage the continuation of the strategies that the women found helpful.
Clinical trials assessing CBT have tended to use the Hot Flush Problem-Rating as the primary outcome measure and hot flush frequency, mood, sleep, and QOL as secondary outcomes. The Hot Flush Rating Scale is a short scale which measures hot flush and night sweat frequency and 'problem rating' (three items including distress, extent to which VMS are a problem and interference with daily routine; Hunter & Liao, 1995;Hunter et al., 2019). Hot flush problem rating is associated with work and social adjustment, QOL, and use of health services. Sternal skin conductance, a psychophysiological measure of VMS, is included in MENOS1  and MENOS2 (Ayers, Smith, Hellier, Mann, & Hunter, 2012) trials, although the concordance between subjective and physiological measures is relatively low .
The trials, including 1,166 women in total, are shown in Table 1 and consistently show moderate to large effect sizes for CBT compared with usual care or wait list control. CBT significantly reduced the impact (problem rating) of VMS, compared with a wait control, in MENOS 1 and 2 trials Mann et al., 2012), including patients with breast cancer and well women, respectively, by an average of 50%, with improvements maintained at 26-week follow-up. Comparison of group CBT with self-help CBT (MENOS2) suggested that both forms of CBT were equally effective in reducing problematic VMS; both improved night sweat frequency and mood, but group CBT resulted in more improvements to QOL compared with self-help CBT. CBT reduced subjective frequency of night sweats by an average of 39% and reduced objectively measured hot flushes (sternal skin conductance monitoring) in well women, but not in patients with breast cancer (Stefanopoulou & Hunter, 2013). This may be due to differences in the nature of menopausal symptoms in patients with breast cancer, since they may be influenced by cancer treatments.
Using a single group design, we found that self-help CBT offered to women with minimal telephone guidance (MENOS3) was effective at comparable levels found in the MENOS 1 and MENOS2 trials (Stefanopoulou & Hunter, 2014). Telephone-based CBT has also been shown to reduce sleep problems and insomnia reported by women during the menopausal transition and postmenopause (McCurry et al., 2016).
In a Dutch study (EVA, Duijts et al., 2012), patients with breast cancer who were premenopausal when diagnosed showed a significant decrease in hot flush problem rating following group CBT compared with physical exercise or usual care at post-treatment and 6-month follow-up. In order to increase accessibility to CBT for this population, we investigated the efficacy of Internet-delivered CBT (iCBT), with and without therapist support, adapted from the MENOS protocols (Atema et al., 2019). Women in the guided iCBT arm received additional support by telephone and weekly online feedback from a trained psychologist or medical social worker. Compliance rates were high. Compared with women in the control group, those in the guided and self-managed iCBT groups reported a significantly greater decrease in the perceived impact of VMS and improvement in sleep quality. At 24-week follow-up, the effects remained significant, and both intervention groups demonstrated a significant reduction in VMS frequency, as well as problem rating. iCBT was effective with and without therapist support, but the improvement was greater with some guidance.
In MENOS4, we tested whether breast cancer nurses can be trained to deliver Group CBT effectively across six oncology centres in England (MENOS4; Fenlon et al., 2020). The nurses were trained by a clinical health psychologist and two CBT groups carried out in each centre. There was a significant (46%) reduction in the mean VMS problem rating score from randomization to 26 weeks in the CBT arm compared with a 15% reduction in the usual care arm. Secondary outcomes, including frequency of VMS, sleep, anxiety, and depression all improved significantly. These results suggest that specialist nurses can be trained to deliver CBT effectively for the alleviation of troublesome menopausal VMS in women following breast cancer in a clinical setting. We conducted the Menos@work RCT to evaluate a brief self-help booklet version of the CBT with women working in eight UK organizations, who were experiencing problematic VMS Hardy, Thorne, et al., 2018). This brief intervention, delivered without any clinical input, significantly reduced VMS frequency and problem-ratings, and improved sleep quality at 6-and 20-week follow-up, compared with a waitlist control group. Measures of work and social adjustment and 'presenteeism' being at work and having difficulty coping with symptomsalso significantly improved for women who had had CBT, compared with those who did not.
Additional studies have addressed the question of how does CBT work and for whom (i.e., moderators and mediators of the treatment effects). With regard to moderators, in MENOS2 CBT was effective regardless of age, body mass index, menopause status, or psychological factors at baseline; in other words, the effect was approximately equal for all participating women . For patients with breast cancer (MENOS1), CBT was effective at reducing VMS problem rating regardless of age, BMI, menopausal status at time of diagnosis, or type of cancer treatment. The treatment effect was significantly greater in women not receiving chemotherapy (although it was still significantly effective for those who had had chemotherapy), those with higher levels of psychological distress at baseline and for non-white women . These findings suggest that CBT is widely applicable for women having problematic HFNS, regardless of sociodemographic or health-related factors.
Secondary mediation analyses of MENOS 1 showed that CBT appeared to work by changing VMS beliefs, that is, cognitive appraisal, and by improving mood and sleep . For women going through the menopause transition (MENOS2), the effect of CBT on VMS problem rating was mediated by changes in cognitions (beliefs about coping/control of hot flushes, beliefs about night sweats and sleep) but not by changes in mood . In subsequent studies (Menos@work, EVA online and Menos4), significant changes in beliefs and behaviours were also evident. As was the case for MENOS1 and 2, the development of healthier beliefs relating to social impact of VMS, perceived control and beliefs about the impact of night sweats on sleep, mediated treatment effects in Eva online using iCBT (Atema et al., 2019). These results support the CBT model and suggest that the CBT works mainly by changing the cognitive appraisal of VMS.
Qualitative interviews with participants at the end of MENOS1 and 2 trials were conducted to explore women's views of the treatment (Balabanovic, Ayers, & Hunter, 2012. Women reported increased confidence and ability to cope with hot flushes and night sweats; key factors mentioned were acceptance and a restored sense of control (experienced on a number of different levels and often facilitated by calm breathing). Many women reported that they attended differently to their hot flushes; for example, they may have had VMS but did not notice them. Perhaps reflecting the skills learned, the beneficial effects of the treatment, in some cases, extended beyond management of menopausal symptoms. Women also found the group context helpful in terms of normalizing their experiences, motivating them in homework tasks, and providing support.
CBT for VMS has also been evaluated for women who have VMS and depression. Conklin et al. (2020) carried out a pilot, single group study using the MENOS protocol for group CBT for 59 women with problematic VMS plus a diagnosis of mood disorders (48 had major depression; 11 bipolar disorder). Pre-post analysis revealed significant improvement for VMS problem rating, mood, anxiety, and QOL. There was good compliance and CBT intervention was considered to be acceptable and feasible for women with psychological disorders. Using a different protocol (CBT-Meno), Green et al. (2019) evaluated a 12-session CBT group-based treatment for women who had both problematic VMS and moderate to severe depressed mood in an exploratory trial with significant reductions in VMS interference and bother, and in self-reported depressive symptoms at 3-month follow-up.
VMS can also affect men. Androgen deprivation therapy (ADT) is a common hormonal treatment for prostate cancer; however, it may be associated with troublesome side effects that include VMS which can be frequent and severe and impact on QOL. In an exploratory trial (MANCAN), we found that a self-help CBT (booklet adapted for men) significantly reduced VMS in men with prostate cancer when delivered by a clinical health psychologist, compared with usual care (Stefanopoulou, Yousaf, Grunfeld, & Hunter, 2015); the improvements were maintained but group differences were not significant at 32 weeks. A multicentre trial is currently in progress that includes more support and a booster group session.
We have worked with community groups supporting black and minority ethnic women through the menopause and found that including the CBT programme in a 12week course reduced women's reports of VMS (Bellott, Rouse, & Hunter, 2018). We are also working with charities such as Maggie's cancer charity and Turning Point, a charity supporting people with a range of health problems, to increase access to the treatment via training and online services. Self-help books (Hunter & Smith 2020, and a group CBT training manual for health professionals (Hunter & Smith, 2015), have been published, so that women can use the self-help CBT themselves and health professionals can offer group CBT for women with problematic VMS. Annual training for health professionals is also available via the British Menopause Society (thebms.org.uk).

Conclusions
The MENOS CBT protocol is a brief therapy (4-6 sessions) that is theory and evidencebased; it is acceptable to women and effectively reduces the impact of VMS, improves sleep, and has benefits to QOL. CBT has been found to be consistently effective when delivered in groups, self-help book, and online formats (with or without additional support). The MENOS CBT protocol has been recommended as an effective non-hormonal treatment for VMS by The North American Menopause Society (2015), and in clinical practice statements (Hickey et al., 2017;Woyka, 2020); and for the treatment of anxiety and depression for women during the menopause transition and postmenopause (NICE, 2015).