Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Study Overview
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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.

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

Conditions
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Takotsubo Cardiomyopathy, Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Mindfulness-Based Sex Therapy
* Other: Treatment as usual


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient and partner<br> | Behavioral: Mindfulness-Based Sex Therapy<br>* 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.<br>|
| Experimental: patient ,partner and cardiac rehabilitation team<br> | Behavioral: Mindfulness-Based Sex Therapy<br>* 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.<br>|
| Active Comparator: Treatment as usual<br> | Other: Treatment as usual<br>* Routine discharge counseling<br>|

What is the study measuring?
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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 |