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Completed

NCT Number: NCT03931187

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infertility Reproductive Center, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive progressive muscular relaxation therapy

Behavioral

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.

Primary outcomes

  1. Change of depression score

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

    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.

  2. Change of anxiety score

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

    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.

Secondary outcomes

  1. Change of Blood Cortisol

    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).

    This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.

  2. Change of sleeping 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).

    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.

  3. Successful conception rate (%)

    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.

    The investigators will count the successful conception rate at each arms.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2019
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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