Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

NCT ID: NCT03372577

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Takotsubo Cardiomyopathy Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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patient and partner

Group Type EXPERIMENTAL

Mindfulness-Based Sex Therapy

Intervention Type BEHAVIORAL

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.

patient ,partner and cardiac rehabilitation team

Group Type EXPERIMENTAL

Mindfulness-Based Sex Therapy

Intervention Type BEHAVIORAL

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 usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Routine discharge counseling

Interventions

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Mindfulness-Based Sex Therapy

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.

Intervention Type BEHAVIORAL

Treatment as usual

Routine discharge counseling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* cognitive disability
* having acute myocardial infarction
* cerebrovascular disease
* pheochromocytoma and viral or idiopathic myocarditis
* , participating in another RCT
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Qazvin University Of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir H Pakpour

Director of Social Determinants of Health Research Center (SDH)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Booali Sina Hospital

Qazvin, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Amir Pakpour, Ph.D.

Role: CONTACT

Phone: +98-28-33239259

Email: [email protected]

Facility Contacts

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Amir Pakpour, Ph.D.

Role: primary

Other Identifiers

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IR.QUMS.REC.1396.188

Identifier Type: -

Identifier Source: org_study_id