Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET

Study Overview
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Brief Summary
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The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.

Official Title
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Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: Cognitive progressive muscular relaxation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment; Junior high school and above; voluntarily accepted for investigation and signed informed consent. Exclusion Criteria: Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders; Experiencing major traumatic events in the past 2 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women intervention arm<br>Intervention will be applied to the women within the couple. | Behavioral: Cognitive progressive muscular relaxation therapy<br>* This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET.<br>|
| Experimental: Couple intervention arm<br>Intervention will be applied to the couple, both men and women. | Behavioral: Cognitive progressive muscular relaxation therapy<br>* This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET.<br>|
| No Intervention: Control arm<br>The couple will receive the normal nursing care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of depression score | The Self-reported Depression Scale （SDS）will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive. | The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month). | 
| Change of anxiety score | The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious. | The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood Cortisol | This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test. | The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month). | 
| Change of sleeping quality | The physical condition closely related to stress. The investigators will use Self-Rating Scale of Sleep to measure the sleeping quality of the participants. The total sore ranges from 5 to 50, with higher score reflects better sleep quality. | The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month). | 
| Successful conception rate (%) | The investigators will count the successful conception rate at each arms. | The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive psychotherapy, progressive muscular relaxation, in vitro fertilization and embryo transfer(IVF-ET), Couples Therapy