Cognitive Behavioural Therapy for Menopausal Symptoms

Menopausal Depression Clinical Trial

— CBTMENO  

Official title:

Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480192
• Other study ID #: OMHF-SG1
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: April 30, 2018

Study information

• Verified date: March 2019
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopausal Depression

Intervention

Other:
• CBT for Menopausal Symptoms (CBT-Meno)
This 12-week CBT-based group treatment program consists of a combination of components including: a) psychoeducation about the nature of menopause including examination about thoughts and beliefs, b) cognitive and behavioural modification related to vasomotor symptoms, c) cognitive-behavioural strategies for depression, e) cognitive-behavioural strategies for anxiety and panic, d) sleep hygiene and cognitive-behavioural strategies for sleep difficulties, f) psychoeducation and lifestyle and behavioural modifications for urogenital complaints, and g) psychoeducation and cognitive-behavioural strategies for sexual concerns.

Locations

Country	Name	City	State
Canada	Women's Health Concerns, St. Joseph's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Ontario Mental Health Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hot Flash Related Daily Interference Scale	The Hot Flash Related Daily Interference Scale assesses the degree to which vasomotor functions interfere with daily life (Carpenter, 2001). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces vasomotor function daily interference, as captured by the Hot Flash Related Daily Interference Scale, compared to pre-treatment and wait-list controls.	12 weeks
Primary	The Beck Depression Inventory	The Beck Depression Inventory is a multiple choice questionnaire which measures depressive symptoms (Beck, Steer & Brown, 1996). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces subjective depressive symptoms, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	The Greene Climacteric Scale - Vasomotor Subscale	The Greene Climacteric Scale is a self-report questionnaire which measures four menopause-related domains: Vasomotor symptoms, depression and anxiety, physical complaints, and sexual concerns (Greene, 1998). The current study aims to explore whether CBGT for menopausal symptoms significantly improves typical menopausal symptoms, as captured by the Greene Climacteric Scale, compared to pre-treatment and wait list controls?	12 weeks
Secondary	The Montgomery-Asberg Depression Rating Scale	The Montgomery-Asberg Depression Rating Scale (Montgomery & Asberg, 1979) is a measure that requires an interview format assessing depressive symptoms in menopausal women and contains a global severity score. The current study aims to explore whether CBGT for menopausal symptoms significantly reduces menopausal depressive symptoms, as captured by the Montgomery-Asberg Depression Rating Scale, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	The Hamilton Anxiety Scale	The Hamilton Anxiety Scale is an interview format rating scale developed to quantify the severity of anxiety symptomatology and contains a global score (Hamilton, 1956). The current study aims to explore whether CBGT for menopausal symptoms significantly improves objective anxiety symptoms, as captured by the Hamilton Anxiety Scale, compared to pre-treatment and wait list controls.	12 weeks
Secondary	The Pittsburgh Sleep Quality Inventory	The Pittsburgh Sleep Quality Inventory (Buysee et al, 1989) is a self-report inventory that contains seven component scores along with one global score indicating overall sleep quality. The current study aims to explore whether CBGT for menopausal symptoms significantly improves sleep disruption, as captured by the Pittsburgh Sleep Quality Inventory, compared to pre-treatment and wait list controls.	12 weeks
Secondary	Ambulatory Sternal Skin-Conductance Monitoring	Vasomotor symptoms will be assessed objectively through ambulatory sternal skin-conductance monitoring which will be worn for 2 consecutive days prior to each assessment. The current study aims to explore whether CBGT for menopausal symptoms significantly reduces vasomotor symptoms (hot flashes/night sweats) compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Female Sexual Functioning Index	Assesses sexual concerns (e.g., arousal, desire, satisfaction) over the past month	12 weeks
Secondary	The Greene Climacteric Scale - Sexual Concerns	The GCS includes an item that assesses sexual concerns in the past week	12 weeks
Secondary	The Utian Quality of Life Scale	Quality of life will be assessed through The Utian Quality of Life Scale (Utian et al, 2002) is a self-report questionnaire which contains four domains namely, occupational, health, emotional, and sexual in addition to a total score representing quality of life. The current study aims to explore whether CBGT for menopausal symptoms significantly improves quality of life compared to pre-treatment and wait list controls.	12 weeks
Secondary	Dysfunctional Attitudes Scale (DAS)	The Dysfunctional Attitudes Scale (DAS; Weissman, 1979) will be used to assess common beliefs about the self, others, and the future that are considered risk factors of depressive symptoms.	12 weeks
Secondary	Depression Anxiety Stress Scale (DASS)	The Depression Anxiety Stress Scale (DASS; Lovibond & Lovibond, 1995) is a self-report questionnaire that assesses three negative emotional states using three scales (depression scale, anxiety scale, and stress scale). The DASS will be used to explore whether CBGT for menopausal symptoms significantly reduces depressive, anxious, and stress related symptoms, as captured by the DASS, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Clinical Global Impression Scale (CGI)	Global severity of illness and change in clinical condition will be assessed using the Clinical Global Impression Scale (CGI; Guy, 1976). The current study aims to explore whether CBGT for menopausal symptoms significantly improves global illness severity, as captured by the CGI, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Beck Anxiety Inventory (BAI)	Changes in subjective somatic or panic-related symptoms of anxiety will be assessed using the Beck Anxiety Inventory (BAI; Beck, 1993). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces anxiety symptoms, as captured by the BAI, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Hot Flash Rating Scale: Frequency & Problem Rating Scale (HFRS-FP)	Changes in frequency of and distress related to hot flashes will be assessed using the Hot Flash Rating Scale: Frequency & Problem Rating Scale (HFRS-FP; Hunter & Liao, 1995). The current study aims to explore whether CBGT for menopausal symptoms reduces the frequency and distress of hot flashes, as captured by the HFRS-FP, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Hot Flash Behaviour Scale (HFBehS)	Changes in behavioural reactions to menopausal hot flashes and night sweats will be assessed using the Hot Flash Behaviour Scale (HFBehS; Hunter & Ayers, 2011). The current study aims to explore whether CBGT for menopausal symptoms has an impact on behavioural reactions to menopausal vasomotor symptoms (hot flashes/ night sweats), as captured by the HFBehS, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Born Steiner Irritability Scale	The Born Steiner Irritability Scale (Born et al., 2004) is a female specific, self-report measure that will be used to assess changes in irritability (annoyance, anger, tension, hostility, and sensitivity to noise and touch). The current study aims to examine whether CBGT for menopausal symptoms is effective in significantly reducing irritability as captured by the Born Steiner Irritability scale, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Menopause Representation Questionnaire (MRQ)	Cognitions about menopause including those about identity, consequences, time frame and perceptions of control and cure will be assessed using the Menopause Representation Questionnaire (MRQ; Hunter & Dea, 2010). The current study aims to explore whether CBGT for menopausal symptoms has an impact on cognitions about menopause, as captured by the MRQ, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Hot Flash Belief Scale (HFBS)	Thoughts associated with the menopausal experience of hot flushes and night sweats will be assessed using the Hot Flash Belief Scale (HFBS; Rendall et al. 2008). The current study aims to explore whether CBGT for menopausal symptoms has an impact on beliefs and thoughts associated with hot flushes and night sweats, as captured by the HFBS, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Anxiety Sensitivity Index-3 (ASI-3)	Changes in anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007). The current study aims to explore whether CBGT for menopausal symptoms significantly reduces fear of anxiety-related situation, as captured by the ASI-3, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Couples Satisfaction Index (CSI-32)	Changes in relationship satisfaction will be assessed using the Couples Satisfaction Index (CSI-32; Funk & Rogge, 2007). The current study aims to explore whether CBGT for menopausal symptoms improves relationship satisfaction, as captured by the CSI-32, compared to pre-treatment and wait-list controls.	12 weeks
Secondary	Client Satisfaction Questionnaire (CSQ)	Participant satisfaction with the CGBT for menopausal symptoms treatment will be assessed using the Client Satisfaction Questionnaire (CSQ; Larsen et al., 1979).	12 weeks