However, many lack adequate research evidence to support
their efficacy or are associated with significant adverse ef-
and reviews recommend further controlled evalua-
tion, particularly for complementary therapies and herbal
There is a need for safe, acceptable, and
effective nonhormonal treatments for women during the meno-
pause transition and postmenopause with problematic symp-
toms, many of whom prefer nonmedical options.
Recent research suggests that psychological factors, includ-
ing emotional reactions such as anxiety or embarrassment, and
negative beliefs and catastrophic thoughts might moderate the
experience of HF/NS
and that relaxation and/or paced
breathing might reduce HF/NS.
Hunter and Liao
oped a cognitive behavioral treatment, including psychoedu-
cation, paced breathing/relaxation, and cognitive behavioral
therapy (CBT) to help women manage HF/NS, which was ac-
ceptable to women and showed promise in exploratory trials
of individual and group CBT, reducing HF/NS by 40% to
However, more evidence is needed to evaluate
CBT interventions using randomized controlled trials (RCTs).
Group and self-help methods of delivering CBT can be cost-
effective alternatives to one-to-o ne treatments.
in a recent systematic review of CBT interventions for depres-
sion and anxiety, guided self-help interventions (eg, using
telephone contacts) were found to be effective and compa-
rable with face-to-face treatments.
HF/NS can be measured by both subjective and physio-
Self-report measures include diary re-
cords of frequency and severity of HF/NS and measures of
the impact of HF/NS on daily life (problem-rating or bother-
Sternal skin conductance (SSC) monitoring is
considered the most valid physiological measure of HF/NS,
although there is discordance between subjective and phys-
iologically measured frequency, and optimal methods of mea-
surement are currently under investigation.
In general, HF/NS
frequency does not correlate highly with severity or bother
caused by HF/NS.
Consequently, HF/NS problem rating or
bother is now considered to be the most appropriate clini-
cal outcome measure because it is associated with help seek-
ing and reduced quality of life.
In the current study, HF/
NS problem rating is the primary outcome measure, and we
include a reliable subjective measure of HF/NS frequency
(Hot Flush Rating Scale
[HFRS]) and a physiological mea-
sure (SSC monitoring) to evaluate treatment effect s.
The aim of the current study was to evaluate the effective-
ness of group CBT and guided self-help CBT in alleviating
HF/NS in women wi th problematic menopausal symptoms in
an RCT. Group and self-help CBT are compared with a no
treatment control (NTC) group at 6 and 26 weeks after random-
ization. It is the first RCT to evaluate CBT for menopause
symptoms using both physiological (SSC) and self-report
measures of HF/NS.
The trial is reported in accordance with the CONSORT
guidelines for randomized control trials
and is described in
detail in a trial protocol article
(trial registration: current con-
trolled trials: ISRCTN57302613). Ethics approval was obtained
from King’s College London Research Ethics Committee (Psy-
chiatry, Nursing, and Midwifery Research Ethics Subcommittee;
reference: PNM/08/09-42). Data were collected at King’s Col-
lege London, and all participants gave written informed consent
before taking part.
Study population and eligibility criteria
Women with variable mens trual cycles (menopausal tran-
sition) or those who were more than 1 year from their last
menstrual period (postmenopause)
with problematic HF/NS
were recruited from South London general practices, breast
screening clinics, a menopause Web site (Menopause Mat-
ters), and local newspaper advertisements between March
2009 and May 2010. Broad inclusion criteria were applied
because we were interested in the impact of self -help CBT
upon less problematic HF/NS. Inclusion criteria were English
speaking; 18 years or older; having problematic HF/NS (score
above 2 on the HFRS
) for at least 1 month (minimum weekly
frequency of 10); living within traveling dista nce of London;
and willingness to maintain, or report any change in, any
menopause treatments, remedies, or supplements at a similar
level during the trial. Exclusion criteria were nonYEnglish
speaking, history of breast cancer, and having medical or psy-
chiatric conditions that would affect the ability to participate.
Potential participants opted into the study in response to
posters and leaflets and contacted the trial coordinator by tele-
phone or e-mail. They were screened by telephone and, if eli-
gible, sent trial information. Those who were interested in
participating attended an assessment interview covering medi-
cal history, menop ausal symptoms, and treatment use. They
also completed a consent form and sociodemographic and
baseline questionnaires and were fitted with an SSC hot flush
monitor (Bahr Monitor; Simplex Scientific LLC), which they
wore for 24 hours and returned the next day. Participants who
consented were randomly allocated to treatment groups (group
CBT, self-help CBT, and NTC) through an Internet random-
ization site (www.random.org) in a 1:1:1 ratio with block sizes
of 18 to 30 participants.
Posttreatment assessments occurred at 6 weeks after ran-
domization. Participants in all three arms of the study com-
pleted questionnaires and 24-hour SSC hot flus h monitoring.
Follow-up assessments occurred at 26 weeks after random-
ization; the participants completed questionnaires and an
interview about their experience of the trial and the interven-
tions (to be reported elsewher e).
Group CBT included 2-hour sessions, once a week, for
4 weeks (8 h in total). The sessions focused on psychoeduca-
tion, stress management, paced breathing, and CBT, including
individual goal setting and homework.
The CBT for
HF/NS is based on a theoretical model of HF/NS, which out-
lines specific components and hypothesizes how these might
750 Menopause, Vol. 19, No. 7, 2012 * 2012 The North American Menopause Society
AYERS ET AL
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