Sleeping through Menopause

Phase 4

Not yet recruiting

Interventions: Drug: Estrogens and Progestogens
Behavioral: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy

Brief Summary: This study aims to evaluate effectiveness of stand alone MHT and a guided online CBTi with CRS on insomnia and depressive symptoms in perimenopausal women. Additionally, the added effect of a combination of MHT and guided online CBTi and CRS will be evaluated on the same outcome measurements. This study aims to ameliorate mental health complaints and improve well-being in perimenopausal women.

Detailed Description: The primary outcome measure is insomnia severity (Bastien et al., 2001). Secondary outcomes address five domains: depressive symptoms, symptoms of other mental health symptoms, climacteric symptoms, daytime functioning and well-being and other sleep measurements. The severity of mental health complaints characterizing different diagnostic dimensions, as well as well-being and daytime functioning including health behaviours and use of care, all assessed by online survey or clinical interview at T0, T1 (2 months) and T2 (4 months).

Climacteric symptoms are assessed with the Green Climacteric Scale at T0, T1, T2. Hot flashes are measured with ambulatory sternal skin conductance monitoring (Purplexus). The other sleep measures include other indicators of sleep and overnight alleviation of distress assessed from the Carney Consensus Sleep Diary, kept online for a week; rest-activity rhythm and activity-based sleep estimates obtained with an actigraph at 7 baseline nights (T0), 7 post-interventions nights (T1) and 7 follow-up nights (T2); objective sleep efficiency, REM sleep fragmentation and heartrate with an ambulatory headband EEG at 5 baseline nights (T0), 5 post-interventions nights (T1) and 5 follow-up nights (T2).

Recruitment & Eligibility

Inclusion Criteria

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 and English

Presence of a menstrual cycle (<1yr since last menstruation)

Exclusion Criteria

CBTi treatment in past 3 months

Bipolar disorder or psychotic disorder

Contra-indication for Menopausal Hormonal Therapy

Use of hormonal contraceptives

Women using thyroid medication of lamotrigine

Women already on MHT

Arm && Interventions

Group	Intervention	Description
HRT	Estrogens and Progestogens	Participants will receive the standard care hormone replacement therapy.
HRT and Sleep modules	Estrogens and Progestogens	Participants will receive both the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy, and the standard care hormone replacement therapy.
HRT and Sleep modules	Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy	Participants will receive both the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy, and the standard care hormone replacement therapy.

Primary Outcome Measures

Name	Time	Method
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). Insomnia severity will be assessed with the Insomnia Severity Index (ISI) (Bastien et al., 2001) at these three timepoints.		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). Insomnia severity will be assessed with the Insomnia Severity Index (ISI) (Bastien et al., 2001) at these three timepoints.

Secondary Outcome Measures

Name	Time	Method
Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS		Individual differences: Sleep history (questionnaire), CTQ, PSST, EPDS
Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband).		Other sleep outcomes: subjective sleep efficiency (sleep diary), objective sleep efficiency, REM sleep fragmentation (EEG headband).
Depressive symptoms: IDS-SR		Depressive symptoms: IDS-SR
Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL		Other mental health outcomes: RMT-20, PMH scale, MHQoL, EuroQoL
Wellbeing and daytime functioning: PLB, Cantrill's ladder		Wellbeing and daytime functioning: PLB, Cantrill's ladder
Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch)		Climacteric symptoms: GCS, HFRDIS, objective frequency hotflushes (watch)

Locations (2): OLVG Stichting
🇳🇱
Amsterdam, Netherlands
Netherlands Institute for Neuroscience
🇳🇱
Amsterdam, Netherlands
OLVG Stichting
🇳🇱Amsterdam, Netherlands
Birit Broekman
Site contact
+31205108911
b.broekman@amsterdamumc.nl