Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

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.

Study Overview

• Status: Unknown
• Conditions: Sexual Dysfunction; Takotsubo Cardiomyopathy
• Intervention / Treatment: Behavioral: Mindfulness-Based Sex Therapy; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir Pakpour, Ph.D.; Phone Number: +98-28-33239259; Email: pakpour_amir@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Recruiting
    • Booali Sina Hospital
    • Contact: Amir Pakpour, Ph.D.; Phone Number: +98-28-33239259; Email: pakpour_amir@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: patient and partner	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.
EXPERIMENTAL: patient ,partner and cardiac rehabilitation team	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.
ACTIVE_COMPARATOR: Treatment as usual	Other: Treatment as usual; Routine discharge counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: December 9, 2017
• First Submitted That Met QC Criteria: December 9, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2017
• Last Update Submitted That Met QC Criteria: December 9, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: IR.QUMS.REC.1396.188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No