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

Central South University67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

Cognitive progressive muscular relaxation therapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Infertility Reproductive Center, Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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