About this trial
Sleepless nights during the menopausal period: what treatment works? About half of the women have trouble sleeping during the years around the menopause, the perimenopause. This is a period characterised by fluctuating sex hormones. Insomnia during the perimenopause can make women more likely to develop more severe climacteric symptoms and other mental health problems. It is therefore important to find the right treatment to treat insomnia. Currently, we do not know what the best treatment is for managing insomnia during the perimenopause. The Sleeping Through Menopause study is the first to evaluate, side by side, two interventions: menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The study aims to evaluate how well these treatments alleviate insomnia and climacteric symptoms including hot flashes, and by doing so alleviate or prevent other mental health issues. It will also explore how personal factors might affect treatment success.
In the study, 222 women with both insomnia and climacteric symptoms will be randomly assigned to one of four groups: MHT, CBCTi, a combination of both MHT and CBCTi, or a group with no treatment. The main goal is to evaluate how each treatment alleviates insomnia after 8 and 15 weeks. Secondary outcomes are sleep quality, climacteric symptoms including hot flashes, mental health, and daily functioning.
This study will help us understand the best ways to treat sleep problems during menopause and whether better sleep can improve other mental health and menopausal symptoms as well.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 40-55 years old
Insomnia severity index score =>10
Green Climacteric Score =>13
Self-considered capability of completing online questionnaires and diaries in Dutch/English
Disqualifiers
CBTi treatment in past year
Bipolar disorder or psychotic disorder
Contra-indication for Menopausal Hormone Therapy
Alcohol or drugs dependency (scores of ≥ 20 on the AUDIT and ≥25 on the DUDIT)
Trial design
Parallel
Treatments tested in this trial
Estrogens and Progestogens
DrugMenopausal Hormone Therapy, formerly known as Hormone Replacement Therapy (HRT), is a medical treatment that involves the use of hormones to relieve the symptoms of menopause and to reduce the risk of certain long-term health conditions associated with menopause. Menopause is a natural biological process that occurs when a women's ovaries stop producing effects, and her estrogen and progesteron hormone levels subsequently decrease. MHT typically involves administration of a combination of sec steroids. In this study MHT consists of estradiol transdermal patches (50 mcg (Systen), which provide a stable release of estradiol and lead to more stable blood levels. This is combined with 200 mg progesterone (Utrogestan tablets for 2 weeks) adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines.
Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy
BehavioralCBTi is a guided, internet-based cognitive behavioral therapy program for insomnia, containing information and exercises on sleep. It consists of five online sessions: 1. Psycho-education on sleep, disordered sleep and sleep hygiene (i.e. general guidelines about health and environmental factors influencing sleep), 2. Sleep restriction (i.e. restrict time in bed to the average sleep time) and stimulus control training (i.e. reinforce association of bed with sleeping), 3. Rumination and relaxation techniques, 4. Cognitive restructuring (i.e. changing misconceptions about sleep), 5. Relapse prevention.
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline).
The Insomnia Severity Index (ISI) is composed of seven items that evaluate the severity of sleep disturbance during the past 2 weeks. Each item is rated on a five-point Likert scale and the total score indicates the severity of insomnia. The higher the more severe.
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