Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Sexual Dysfunction Clinical Trial

Official title:

Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03372577
• Other study ID #: IR.QUMS.REC.1396.188
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2017
• Last updated: December 9, 2017
• Start date: December 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: December 2017
• Source: Qazvin University Of Medical Sciences
• Contact: Amir Pakpour, Ph.D.
• Phone: +98-28-33239259
• Email: pakpour_amir[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: July 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Sexual Dysfunction
• Takotsubo Cardiomyopathy

Intervention

Behavioral:
• 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.

Other:
• Treatment as usual
Routine discharge counseling

Locations

Country	Name	City	State
Iran, Islamic Republic of	Booali Sina Hospital	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Mindfulness	Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	Marital satisfaction	The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	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	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	Rumination	Rumination is measured using Ruminative Thought Style Questionnaire (RTS). The RTS contains 20 items describing positive, negative and neutral facets of global rumination	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	Emotion regulation	Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	quality of life	HRQoL is measured using Short Form health survey (SF-12).	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	Social Support	Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).	changes from baseline, 1 Months ,6 months, 12 months and 18 months
Secondary	Sense of Coherence	Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).	changes from baseline, 1 Months ,6 months, 12 months and 18 months