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

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

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 Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Cognitive progressive muscular relaxation therapy

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Infertility Reproductive Center, Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women intervention arm; Intervention will be applied to the women within the couple.	Behavioral: Cognitive progressive muscular relaxation therapy; 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.
Experimental: Couple intervention arm; Intervention will be applied to the couple, both men and women.	Behavioral: Cognitive progressive muscular relaxation therapy; 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.
No Intervention: Control arm; The couple will receive the normal nursing care.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Couples Therapy; cognitive psychotherapy; progressive muscular relaxation; in vitro fertilization and embryo transfer(IVF-ET)
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Intervention on IVF-ET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participants are not willing to share the data.

Drug and device information, study documents

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