Bipolar DisorderConklin MWWNCT02860910
Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders
A study testing Cognitive Behavioral Group Therapy in people with Bipolar Disorder and Major Depressive Disorder, run by Danette Conklin, PhD at 1 site in United States.
Trial summary
The general objective of this study is to advance insight into non-pharmacological treatments for maturing women that impact psychological health and wellbeing of women adapting to menopause, a natural but often challenging developmental milestone. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder, Menopause
- What is being tested?
- Cognitive Behavioral Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 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
- Self-identified as African-American or Caucasian females between 40-65 experiencing the early, late peri-menopause or early or late post-menopause stages of reproductive aging defined by The North American Menopause Society (NAMS, 2014), Menopause Practice guidelines, stages of reproductive aging. There are situations in which menopause status will not be able to be determined, such as with women who have had a hysterectomy. However, if the potential study participant meets all other inclusion criteria, then she can be enrolled in the study.
- Diagnosed with current or lifetime bipolar disorder or major depressive disorder as assessed by the MINI International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual-5 (DSM-5).
- Menopause symptoms can be natural or surgically induced.
- Willing to remain on current dose of psychotropic medications until the study has concluded.
- Experiencing one or more hot flashes and/or night sweats per day.
- Willing to have the 6 CBGT interventions audio recorded.
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- English speaking with at least a high school education.
- Montgomery-Asberg Depression Rating Scale (MADRS) total score > 7
- Women stable on psychotropic medications for ≥ 8 weeks.
- Medication regimens to treat their DSM-V diagnoses will be encouraged to continue in order to determine if the CBGT accounted for any change in symptoms.
Who cannot join
- Unwilling or unable to comply to study requirements.
- Women diagnosed with schizophrenia, schizoaffective, borderline personality disorder, and/or active psychosis, as confirmed by MINI.
- Diagnosed with active substance use disorder within past 12 months as confirmed on the MINI.
- Women currently treated with hormone therapy (HT) for Vasomotor Symptoms (VMS).
- Diagnosed with current post-traumatic stress disorder (PTSD).
- Participants experiencing acute mania as defined by a Young Mania Rating Scale (YMRS) score > 15
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- Serious suicidal risks judged by the investigator or having score equal or greater than 4 on MADRS item number 10 at screening or baseline.
- Participants being treated with chemotherapy and/or tamoxifen.
- Women who are not self-identifying as either African-American or Caucasian.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, 44106
About this study
Official title: Cross-Cultural Cognitive Behavioral Group Therapy: Evaluating the Effectiveness of a Manualized Cognitive Behavior Group Therapy Treatment for the Management of Menopause Symptoms in a Mood and Anxiety Disorder Population
The general objective of this study is to advance insight into non-pharmacological treatments for maturing women that impact psychological health and wellbeing of women adapting to menopause, a natural but often challenging developmental milestone.
Read the detailed description
This exploratory study proposes to expand the knowledge in the menopausal literature and evaluate the effectiveness of cognitive-behavioral group therapy (CBGT) in reducing problematic vasomotor symptoms, reducing daily interference and improving quality of life. The study will include two homogenous peri- or post-menopausal cohorts (African-American and Caucasian) with major depressive disorder or bipolar disorder. The intervention will be delivered in groups of 6 to 10 participants per group of both race/ethnicities in an outpatient setting during a 6-week time period. The participants will be assessed on the degree of hot flash problem rating, hot flash related daily interference, and menopause quality of life at screening, baseline, and post-treatment. Participants will also be assessed using the following predictor variables at the same time points: body mass index (BMI), level of perceived stress, severity of depression, severity of anxiety level of pleasure, severity of mania, hot flash beliefs and severity of couple's conflict.
- Conditions
- Bipolar Disorder, Major Depressive Disorder, Menopause
- Being tested
- Cognitive Behavioral Group Therapy
- Keywords
- hot flashes, postmenopause, perimenopause
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Group Therapy | Experimental | The six CBGT sessions are outlined in the manual entitled: Managing Hot Flushes with Group Cognitive Behaviour Therapy: An Evidenced-Based Treatment Manual for Health Care Professionals (Hunter \& Smith, 2015) as follows:
Session 1: Psycho-education and the cognitive behavioural model Session 2: Stress management, improving wellbeing and identifying precipitants Session 3: Managing hot flushes using a cognitive behavioural approach Session 4: Managing night sweats and improving sleep (part one) Session 5: Managing night sweats and improving sleep (part two) Session 6: Review and maintaining changes (One alteration: Open discussion about mood disorders, anxiety and the psychological impact instead of the psychological impact of breast cancer) Receives: Behavioral: Cognitive Behavioral Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who begin cognitive group behavioral therapy
Measured: 2 years
Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score
Measured: Baseline and Week 6
Secondary outcomes (2)
Change in Hot Flash Daily Interference Scale (HFRDIS) total score
Measured: Baseline and Week 6
Change in Menopause Representation Questionnaire (MRQ) total score
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionOct 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 Bipolar DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danette Conklin, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Danette Conklin, PhD, University Hospitals Cleveland Medical Center
- Investigators
- Danette Conklin, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860910
- Sponsor's protocol ID
- 04-16-11
- Acronym
- Conklin MWW
- Status last verified
- Sep 2019
- First submitted
- 14 Jun 2016
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Conklin D, Carpenter JS, Whitney MS, DeLozier S, Ogede DO, Bazella C, McVoy M, Sajatovic M. Narrative Analyses: Cognitive Behavior Group Therapy for Women with Menopause and Bipolar or Major Depressive Disorders. Womens Health Rep (New Rochelle). 2021 Sep 22;2(1):430-442. doi: 10.1089/whr.2021.0025. eCollection 2021.
PubMed 34671764Conklin DY, Goto T, Ganocy S, Loue S, LaGrotta C, Delozier S, Brownrigg B, Conroy C, D'Arcangelo N, Janes J, Ogede D, Sajatovic M. Manualized cognitive behavioral group therapy to treat vasomotor symptoms for women diagnosed with mood disorders. J Psychosom Res. 2020 Jan;128:109882. doi: 10.1016/j.jpsychores.2019.109882. Epub 2019 Nov 20.
PubMed 31837624
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Cognitive Behavioral Group Therapy: Evaluating the Effectiveness of a Manualized Cognitive Behavior Group Therapy Treatment for the Management of Menopause Symptoms in a Mood and Anxiety Disorder Population
- ClinicalTrials.gov ID
- NCT02860910
- Acronym / sponsor ID
- Conklin MWW / 04-16-11
- Conditions
- Bipolar Disorder, Major Depressive Disorder, Menopause
- Keywords
- hot flashes, postmenopause, perimenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Danette Conklin, PhDUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 9 Aug 2016 (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.
The general objective of this study is to advance insight into non-pharmacological treatments for maturing women that impact psychological health and wellbeing of women adapting to menopause, a natural but often challenging developmental milestone.
Detailed description
This exploratory study proposes to expand the knowledge in the menopausal literature and evaluate the effectiveness of cognitive-behavioral group therapy (CBGT) in reducing problematic vasomotor symptoms, reducing daily interference and improving quality of life. The study will include two homogenous peri- or post-menopausal cohorts (African-American and Caucasian) with major depressive disorder or bipolar disorder. The intervention will be delivered in groups of 6 to 10 participants per group of both race/ethnicities in an outpatient setting during a 6-week time period. The participants will be assessed on the degree of hot flash problem rating, hot flash related daily interference, and menopause quality of life at screening, baseline, and post-treatment. Participants will also be assessed using the following predictor variables at the same time points: body mass index (BMI), level of perceived stress, severity of depression, severity of anxiety level of pleasure, severity of mania, hot flash beliefs and severity of couple's conflict.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Group Therapy | Experimental | Behavioral: Cognitive Behavioral Group TherapyThe six CBGT sessions are outlined in the manual entitled: Managing Hot Flushes with Group Cognitive Behaviour Therapy: An Evidenced-Based Treatment Manual for Health Care Professionals (Hunter \& Smith, 2015) as follows: Session 1: Psycho-education and the cognitive behavioural model Session 2: Stress management, improving wellbeing and identifying precipitants Session 3: Managing hot flushes using a cognitive behavioural approach Session 4: Managing night sweats and improving sleep (part one) Session 5: Managing night sweats and improving sleep (part two) Session 6: Review and maintaining changes (One alteration: Open discussion about mood disorders, anxiety and the psychological impact instead of the psychological impact of breast cancer) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Self-identified as African-American or Caucasian females between 40-65 experiencing the early, late peri-menopause or early or late post-menopause stages of reproductive aging defined by The North American Menopause Society (NAMS, 2014), Menopause Practice guidelines, stages of reproductive aging. There are situations in which menopause status will not be able to be determined, such as with women who have had a hysterectomy. However, if the potential study participant meets all other inclusion criteria, then she can be enrolled in the study.
- Diagnosed with current or lifetime bipolar disorder or major depressive disorder as assessed by the MINI International Neuropsychiatric Interview (MINI) for Diagnostic and Statistical Manual-5 (DSM-5).
- Menopause symptoms can be natural or surgically induced.
- Willing to remain on current dose of psychotropic medications until the study has concluded.
- Experiencing one or more hot flashes and/or night sweats per day.
Key exclusion criteria (9 listed)
- Unwilling or unable to comply to study requirements.
- Women diagnosed with schizophrenia, schizoaffective, borderline personality disorder, and/or active psychosis, as confirmed by MINI.
- Diagnosed with active substance use disorder within past 12 months as confirmed on the MINI.
- Women currently treated with hormone therapy (HT) for Vasomotor Symptoms (VMS).
- Diagnosed with current post-traumatic stress disorder (PTSD).
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 |
|---|---|---|
| Cognitive Behavioral Group Therapy | Behavioural | Cognitive Behavioral Group Therapy |
Primary outcome
Number of participants who begin cognitive group behavioral therapy
Time frame: 2 years
Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score
Time frame: Baseline and Week 6
2 secondary outcomes
Change in Hot Flash Daily Interference Scale (HFRDIS) total score
Time frame: Baseline and Week 6
Change in Menopause Representation Questionnaire (MRQ) total score
Time frame: Baseline and Week 6
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 30 Sep 2019.
- Derived from this study: PubMed 34671764Conklin D, Carpenter JS, Whitney MS, DeLozier S, Ogede DO, Bazella C, McVoy M, Sajatovic M. Narrative Analyses: Cognitive Behavior Group Therapy for Women with Menopause and Bipolar or Major Depressive Disorders. Womens Health Rep (New Rochelle). 2021 Sep 22;2(1):430-442. doi: 10.1089/whr.2021.0025. eCollection 2021.
- Derived from this study: PubMed 31837624Conklin DY, Goto T, Ganocy S, Loue S, LaGrotta C, Delozier S, Brownrigg B, Conroy C, D'Arcangelo N, Janes J, Ogede D, Sajatovic M. Manualized cognitive behavioral group therapy to treat vasomotor symptoms for women diagnosed with mood disorders. J Psychosom Res. 2020 Jan;128:109882. doi: 10.1016/j.jpsychores.2019.109882. Epub 2019 Nov 20.
- Individual participant dataSharing planned: No
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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.
Danette Conklin, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Group Therapy in people with Bipolar Disorder and Major Depressive Disorder, run by Danette Conklin, PhD at 1 site in United States.
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 10 inclusion and 9 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 30 Sep 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 United States. 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?
Number of participants who begin cognitive group behavioral therapy (time frame: 2 years). 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 NCT02860910, 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 30 Sep 2019.