Clinical trial NCT02480192: Cognitive Behavioural Therapy for Menopausal Symptoms
Official title: Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal Depression
Keywords: Vasomotor
Symptoms
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
First posted: 2015-06-24
Enrollment: 72
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind, randomized controlled trial was conducted to assess the effectiveness of the CBT-Meno program compared to a waitlist comparison condition.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
2. A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
3. 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).
4. 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,
5. Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.

Exclusion Criteria:

1. 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,
2. Participants with Psychotic Disorders, or current Substance Dependence.

Primary outcomes:
measure: The Hot Flash Related Daily Interference Scale
timeFrame: 12 weeks
measure: The Beck Depression Inventory
timeFrame: 12 weeks
Secondary outcomes:
measure: The Greene Climacteric Scale - Vasomotor Subscale
timeFrame: 12 weeks
measure: The Montgomery-Asberg Depression Rating Scale
timeFrame: 12 weeks
measure: The Hamilton Anxiety Scale
timeFrame: 12 weeks
measure: The Pittsburgh Sleep Quality Inventory
timeFrame: 12 weeks
measure: Ambulatory Sternal Skin-Conductance Monitoring
timeFrame: 12 weeks
measure: Female Sexual Functioning Index
timeFrame: 12 weeks
measure: The Greene Climacteric Scale - Sexual Concerns
timeFrame: 12 weeks
measure: The Utian Quality of Life Scale
timeFrame: 12 weeks
measure: Dysfunctional Attitudes Scale (DAS)
timeFrame: 12 weeks
measure: Depression Anxiety Stress Scale (DASS)
timeFrame: 12 weeks
measure: Clinical Global Impression Scale (CGI)
timeFrame: 12 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: 12 weeks
measure: Hot Flash Rating Scale: Frequency & Problem Rating Scale (HFRS-FP)
timeFrame: 12 weeks
measure: Hot Flash Behaviour Scale (HFBehS)
timeFrame: 12 weeks
measure: Born Steiner Irritability Scale
timeFrame: 12 weeks
measure: Menopause Representation Questionnaire (MRQ)
timeFrame: 12 weeks
measure: Hot Flash Belief Scale (HFBS)
timeFrame: 12 weeks
measure: Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: 12 weeks
measure: Couples Satisfaction Index (CSI-32)
timeFrame: 12 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns, St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care
name: Sheryl Green, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donegan E, Frey BN, McCabe RE, Streiner DL, Fedorkow DM, Furtado M, Green SM. Impact of the CBT-Meno protocol on menopause-specific beliefs, dysfunctional attitudes, and coping behaviors. Menopause. 2022 Aug 1;29(8):963-972. doi: 10.1097/GME.0000000000002003.
citation: Green SM, Donegan E, McCabe RE, Fedorkow DM, Streiner DL, Frey BN. Objective and subjective vasomotor symptom outcomes in the CBT-Meno randomized controlled trial. Climacteric. 2020 Oct;23(5):482-488. doi: 10.1080/13697137.2020.1737929. Epub 2020 Apr 17.