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Cognitive Behavioural Therapy for Menopausal Symptoms (CBTMENO)

This study is currently recruiting participants.
Verified April 2016 by Sheryl Green, St. Joseph's Healthcare Hamilton
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480192
First Posted: June 24, 2015
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Sheryl Green, St. Joseph's Healthcare Hamilton
  Purpose
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) in some women. Cognitive-behavioural therapy (CBT), has been proposed as a low-risk treatment for menopausal symptoms and received some initial support. The investigators developed a comprehensive non-pharmacological, CBT based treatment program for menopausal symptoms, published the treatment manual, and have initial evidence supporting its effectiveness with the investigators' published pilot data. The investigators' goal is to conduct a large randomized controlled trial of Cognitive Behavioural Group Therapy (CBGT) for the improvement of menopausal symptoms. The investigators hypothesize that participants will experience fewer and less intense/disruptive hot flashes/night sweats, reduced depression and anxiety and improvement in sleep difficulties, sexual concerns, and overall quality of life. The investigators also predict that these benefits will be maintained at follow up and there will be high satisfaction associated with the program by participants.

Condition Intervention
Menopausal Depression Other: Cognitive Behavioural Therapy for Menopausal Symptoms

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sheryl Green, St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Ambulatory Sternal Skin-Conductance Monitoring [ Time Frame: 12 weeks ]
    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.

  • The Beck Depression Inventory [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures:
  • The Hot Flash Related Daily Interference Scale [ Time Frame: 12 weeks ]
    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.

  • The Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks ]
    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.

  • The Greene Climacteric Scale [ Time Frame: 12 weeks ]
    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?

  • The Beck Anxiety Inventory [ Time Frame: 12 weeks ]
    The Beck Anxiety Invetory is a self-report measure measuring subjective, somatic or panic-related symptoms of anxiety (Beck, 1993). The current study aims to explore whether CBGT for menopausal symptoms significantly improves subjective anxiety symptoms, as captured subjectively by the Beck Anxiety Inventory, compared to pre-treatment and wait list controls.

  • The Hamilton Anxiety Scale [ Time Frame: 12 weeks ]
    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.

  • The Pittsburgh Sleep Quality Inventory [ Time Frame: 12 weeks ]
    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.

  • The Utian Quality of Life Scale [ Time Frame: 12 weeks ]
    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.


Estimated Enrollment: 80
Study Start Date: June 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group
After an initial assessment, the experimental group will receive 12 weekly sessions (2 hours long) of Cognitive Behavioural Group Therapy (n=8 per group) for menopausal symptoms including vasomotor symptoms and depressive symptoms. They will then be re-assessed at post-treatment and 3 months post-treatment to determine the effectiveness of the treatment and whether these effects are maintained 3 months after treatment.
Other: Cognitive Behavioural Therapy for Menopausal Symptoms
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.
No Intervention: Wait-List Control
After an initial assessment, the wait-list control group will not receive any treatment for 12 weeks. They will then be re-assessed after 12 weeks and this data will be used to compare this group to the experimental group to determine the effectiveness of the treatment. After this re-assessment they will be offered the same treatment as the experimental group: 12 weekly sessions (2 hours long) of Cognitive Behavioural Group Therapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Menopausal staging: perimenopause or early postmenopause, as per STRAW definition (Harlow et al., 2012)
  2. A minimal of a Moderate level of severity of depressive symptoms (defined by the Beck Depression Inventory),
  3. Significant vasomotor symptoms (defined as sub-score of 3 or more on the vasomotor sub-scale of Greene's Climacteric Scale (Greene, 1998). Further, participants have to report significant occurrence of hot flashes (defined as at least 4/day or 30/week) and that these hot flashes have a significant negative impact on their functioning (defined by a score of 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480192


Contacts
Contact: Sheryl Green, PhD, C.Psych 905-522-1155 ext 33672 sgreen@stjoes.ca

Locations
Canada, Ontario
Women's Health Concerns, St. Joseph's Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Sheryl Green, PhD, C.Psych    905-522-1155 ext 39064    sgreen@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Ontario Mental Health Foundation
Investigators
Principal Investigator: Sheryl Green, PhD, C.Psych St. Joseph's Health Care
  More Information

Responsible Party: Sheryl Green, Clinical Health Psychologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02480192     History of Changes
Other Study ID Numbers: OMHF-SG1
First Submitted: May 22, 2015
First Posted: June 24, 2015
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Sheryl Green, St. Joseph's Healthcare Hamilton:
Vasomotor
Symptoms