Takotsubo CardiomyopathyNCT03372577
Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy
A study testing Mindfulness-Based Sex Therapy and Treatment as usual in people with Takotsubo Cardiomyopathy and Sexual Dysfunction, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a sudden temporary weakening of the myocardium. . In a recent study, women report more sexual dysfunction than men after 1 year after TC. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Takotsubo Cardiomyopathy, Sexual Dysfunction
- What is being tested?
- Mindfulness-Based Sex Therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2017to 1 Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years old at least
- confirmed diagnosis of TC by a cardiologist according Mayo Clinic diagnostic criteria; an acute left ventricular apical ballooning of unknown cause
- willingness to partaking for the duration of the trial
- a basic fluency in Persian
- living with a partner/spouse
Who cannot join
- cognitive disability
- having acute myocardial infarction
- cerebrovascular disease
- pheochromocytoma and viral or idiopathic myocarditis
- , participating in another RCT
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Booali Sina Hospital
Qazvin, 3419759811
Amir Pakpour, Ph.D., +98-28-33239259, pakpour_amir@yahoo.com
About this study
Official title: Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women
Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a sudden temporary weakening of the myocardium. . In a recent study, women report more sexual dysfunction than men after 1 year after TC. Despite that a number of studies have assessed female sexual dysfunction (FSD) for TC , there is no information regarding prevalence and associated factors on FSD in women with TC. However, in a recent study on Iranian female patients with TC, more than 77% of these patients suffered from FSD. This study is aimed to assess the effectiveness of a Mindfulness-based Sex Therapy on Patients With TC.
- Conditions
- Takotsubo Cardiomyopathy, Sexual Dysfunction
- Being tested
- Mindfulness-Based Sex Therapy, Treatment as usual
- Medical subject headings
- Takotsubo Cardiomyopathy, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Sex TherapyBehavioural
It is based on an integration of psychoeducation, sex therapy, and mindfulness-based skills. the intervention will be delivered by a group of facilitators on a group based weekly.
Treatment as usualOther
Routine discharge counseling
| Study group | Role | What they receive |
|---|---|---|
| patient and partner | Experimental | Not described Receives: Behavioral: Mindfulness-Based Sex Therapy |
| patient ,partner and cardiac rehabilitation team | Experimental | Not described Receives: Behavioral: Mindfulness-Based Sex Therapy |
| Treatment as usual | Active comparator | Not described Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual functioning
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sexual Distress
Female Sexual Distress Scale;The FSDS-R is a self-reported questionnaire consisting of 13 items assessing different aspects of sexual activity-related distress in women
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Intimacy
Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary outcomes (8)
Mindfulness
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Psychological distress
Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Rumination
Rumination is measured using Ruminative Thought Style Questionnaire (RTS). The RTS contains 20 items describing positive, negative and neutral facets of global rumination
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Emotion regulation
Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
quality of life
HRQoL is measured using Short Form health survey (SF-12).
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Social Support
Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sense of Coherence
Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).
Measured: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372577
- Sponsor's protocol ID
- IR.QUMS.REC.1396.188
- Status last verified
- Dec 2017
- First submitted
- 9 Dec 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women
- ClinicalTrials.gov ID
- NCT03372577
- Acronym / sponsor ID
- IR.QUMS.REC.1396.188
- Conditions
- Takotsubo Cardiomyopathy, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 13 Dec 2017 (actual)
- 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.
Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a sudden temporary weakening of the myocardium. . In a recent study, women report more sexual dysfunction than men after 1 year after TC. Despite that a number of studies have assessed female sexual dysfunction (FSD) for TC , there is no information regarding prevalence and associated factors on FSD in women with TC. However, in a recent study on Iranian female patients with TC, more than 77% of these patients suffered from FSD. This study is aimed to assess the effectiveness of a Mindfulness-based Sex Therapy on Patients With TC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient and partner | Experimental | Behavioral: Mindfulness-Based Sex Therapy |
| patient ,partner and cardiac rehabilitation team | Experimental | Behavioral: Mindfulness-Based Sex Therapy |
| Treatment as usual | Active comparator | Other: Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years old at least
- confirmed diagnosis of TC by a cardiologist according Mayo Clinic diagnostic criteria; an acute left ventricular apical ballooning of unknown cause
- willingness to partaking for the duration of the trial
- a basic fluency in Persian
- living with a partner/spouse
Key exclusion criteria (5 listed)
- cognitive disability
- having acute myocardial infarction
- cerebrovascular disease
- pheochromocytoma and viral or idiopathic myocarditis
- , participating in another RCT
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 |
|---|---|---|
| Mindfulness-Based Sex TherapyIt is based on an integration of psychoeducation, sex therapy, and mindfulness-based skills. the intervention will be delivered by a group of facilitators on a group based weekly. | Behavioural | patient ,partner and cardiac rehabilitation team, patient and partner |
| Treatment as usualRoutine discharge counseling | Other | Treatment as usual |
Primary outcome
Sexual functioning
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Sexual Distress
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Female Sexual Distress Scale;The FSDS-R is a self-reported questionnaire consisting of 13 items assessing different aspects of sexual activity-related distress in women
Intimacy
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales
8 secondary outcomes
Mindfulness
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Marital satisfaction
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Psychological distress
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Rumination
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Emotion regulation
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
quality of life
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Social Support
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sense of Coherence
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
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Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Sex Therapy and Treatment as usual in people with Takotsubo Cardiomyopathy and Sexual Dysfunction, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2017. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Pakpour, Ph.D. (+98-28-33239259, pakpour_amir@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual functioning (time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2017.