Menopausal DepressionCBTMENONCT02480192
Cognitive Behavioural Therapy for Menopausal Symptoms
A study testing CBT for Menopausal Symptoms (CBT-Meno) in people with Menopausal Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Menopausal Depression
- What is being tested?
- CBT for Menopausal Symptoms (CBT-Meno)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2015to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
- A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
- 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).
- 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,
- Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.
Who cannot join
- 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,
- Participants with Psychotic Disorders, or current Substance Dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Menopausal Depression
- Being tested
- CBT for Menopausal Symptoms (CBT-Meno)
- Keywords
- Vasomotor, Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Menopausal Symptoms (CBT-Meno)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (CBT-Meno) | Experimental | After an initial assessment, the experimental group received 12 weekly sessions (2 hours each) of group-based cognitive-behavioural therapy for menopausal symptoms (CBT-Meno) (up to n=8 per group). Symptoms that were targeted included vasomotor symptoms (hot flashes/night sweats), depressive symptoms, anxiety, poor sleep, and sexual concerns. Participants were re-assessed at 12-weeks post-baseline and at 3 months post-treatment. Receives: Other: CBT for Menopausal Symptoms (CBT-Meno) |
| Waitlist | No intervention | After an initial assessment, the waitlist comparison group did not receive any treatment for 12 weeks. They were then re-assessed at 12-weeks post-baseline and this data was used to compare this group to the experimental group to determine the effectiveness of the CBT-Meno treatment. After this re-assessment participants in the waitlist condition were offered the same CBT-Meno treatment as the experimental group: 12 weekly sessions (2 hours long) of cognitive-behavioural therapy for menopausal symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (20)
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?
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Female Sexual Functioning Index
Assesses sexual concerns (e.g., arousal, desire, satisfaction) over the past month
Measured: 12 weeks
The Greene Climacteric Scale - Sexual Concerns
The GCS includes an item that assesses sexual concerns in the past week
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menopausal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
- Investigators
- Sheryl Green, PhD, C.Psych, Principal investigator, St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480192
- Sponsor's protocol ID
- OMHF-SG1
- Acronym
- CBTMENO
- Status last verified
- Mar 2019
- First submitted
- 22 May 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35881942Green 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.
PubMed 32299247
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy for Menopausal Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02480192
- Acronym / sponsor ID
- CBTMENO / OMHF-SG1
- Conditions
- Menopausal Depression
- Keywords
- Vasomotor, Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (CBT-Meno) | Experimental | Other: CBT for Menopausal Symptoms (CBT-Meno)After an initial assessment, the experimental group received 12 weekly sessions (2 hours each) of group-based cognitive-behavioural therapy for menopausal symptoms (CBT-Meno) (up to n=8 per group). Symptoms that were targeted included vasomotor symptoms (hot flashes/night sweats), depressive symptoms, anxiety, poor sleep, and sexual concerns. Participants were re-assessed at 12-weeks post-baseline and at 3 months post-treatment. |
| Waitlist | No intervention | –After an initial assessment, the waitlist comparison group did not receive any treatment for 12 weeks. They were then re-assessed at 12-weeks post-baseline and this data was used to compare this group to the experimental group to determine the effectiveness of the CBT-Meno treatment. After this re-assessment participants in the waitlist condition were offered the same CBT-Meno treatment as the experimental group: 12 weekly sessions (2 hours long) of cognitive-behavioural therapy for menopausal symptoms. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Menopausal staging: perimenopause or postmenopausal as per STRAW definitions (Harlow et al., 2012) or having surgically-induced menopause
- A minimum of mild level of severity of depressive symptoms (defined by the Beck Depression Inventory, scores of 14 or greater during initial screen),
- 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).
- 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,
- Speak, read, and write in English sufficiently to comprehend testing procedures and written materials in group treatment.
Key exclusion criteria (2 listed)
- 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,
- Participants with Psychotic Disorders, or current Substance Dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental Group (CBT-Meno) |
Primary outcome
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 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.
20 secondary outcomes
The Greene Climacteric Scale - Vasomotor Subscale
Time frame: 12 weeks
The Montgomery-Asberg Depression Rating Scale
Time frame: 12 weeks
The Hamilton Anxiety Scale
Time frame: 12 weeks
The Pittsburgh Sleep Quality Inventory
Time frame: 12 weeks
Ambulatory Sternal Skin-Conductance Monitoring
Time frame: 12 weeks
Female Sexual Functioning Index
Time frame: 12 weeks
The Greene Climacteric Scale - Sexual Concerns
Time frame: 12 weeks
The Utian Quality of Life Scale
Time frame: 12 weeks
Dysfunctional Attitudes Scale (DAS)
Time frame: 12 weeks
Depression Anxiety Stress Scale (DASS)
Time frame: 12 weeks
Clinical Global Impression Scale (CGI)
Time frame: 12 weeks
Beck Anxiety Inventory (BAI)
Time frame: 12 weeks
Hot Flash Rating Scale: Frequency & Problem Rating Scale (HFRS-FP)
Time frame: 12 weeks
Hot Flash Behaviour Scale (HFBehS)
Time frame: 12 weeks
Born Steiner Irritability Scale
Time frame: 12 weeks
Menopause Representation Questionnaire (MRQ)
Time frame: 12 weeks
Hot Flash Belief Scale (HFBS)
Time frame: 12 weeks
Anxiety Sensitivity Index-3 (ASI-3)
Time frame: 12 weeks
Couples Satisfaction Index (CSI-32)
Time frame: 12 weeks
Client Satisfaction Questionnaire (CSQ)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 35881942Donegan 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.
- Derived from this study: PubMed 32299247Green 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Green, PhD, C.Psych principal investigator
St. Joseph's Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Menopausal Symptoms (CBT-Meno) in people with Menopausal Depression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hot Flash Related Daily Interference Scale (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480192, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.