Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

NCT03372577 | Unknown DMC

• 1 other identifier: IR.QUMS.REC.1396.188
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Sexual functioning

  Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)

  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

  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

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

Secondary Outcomes (8)

• Mindfulness

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

• Marital satisfaction

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

• Psychological distress

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

• Rumination

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

• Emotion regulation

  changes from baseline, 1 Months ,6 months, 12 months and 18 months

Study Arms (3)

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

Interventions

Mindfulness-Based Sex Therapy 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; patient and partner

Treatment as usual OTHER

Routine discharge counseling

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cognitive disability
• having acute myocardial infarction
• cerebrovascular disease
• pheochromocytoma and viral or idiopathic myocarditis
• , participating in another RCT

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Booali Sina Hospital

Qazvin, 3419759811, Iran

RECRUITING

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Sexual Dysfunction, Physiological

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Genital Diseases; Urogenital Diseases

Central Study Contacts

Amir Pakpour, Ph.D.

CONTACT

+98-28-33239259; pakpour_amir@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Social Determinants of Health Research Center (SDH)

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 13, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: December 13, 2017

Record last verified: 2017-12

Locations

IR (1)