Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372577
Recruitment Status : Unknown
Verified December 2017 by Amir H Pakpour, Qazvin University Of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Amir H Pakpour, Qazvin University Of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Takotsubo Cardiomyopathy Sexual Dysfunction Behavioral: Mindfulness-Based Sex Therapy Other: Treatment as usual Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Mindfulness [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters

  2. Marital satisfaction [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.

  3. Psychological distress [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations

  4. Rumination [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Rumination is measured using Ruminative Thought Style Questionnaire (RTS). The RTS contains 20 items describing positive, negative and neutral facets of global rumination

  5. Emotion regulation [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).

  6. quality of life [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    HRQoL is measured using Short Form health survey (SF-12).

  7. Social Support [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).

  8. Sense of Coherence [ Time Frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months ]
    Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372577


Contacts
Layout table for location contacts
Contact: Amir Pakpour, Ph.D. +98-28-33239259 pakpour_amir@yahoo.com

Locations
Layout table for location information
Iran, Islamic Republic of
Booali Sina Hospital Recruiting
Qazvin, Iran, Islamic Republic of, 3419759811
Contact: Amir Pakpour, Ph.D.    +98-28-33239259    pakpour_amir@yahoo.com   
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Layout table for additonal information
Responsible Party: Amir H Pakpour, Director of Social Determinants of Health Research Center (SDH), Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT03372577    
Other Study ID Numbers: IR.QUMS.REC.1396.188
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction