CClinicalTrials.gg
CompletedNCT03931187Updated Dec 14, 2021

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

An interventional study of Cognitive progressive muscular relaxation therapy in Infertility, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by Central South University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Infertility

Browse trials for

Keywords

  • cognitive psychotherapy
  • progressive muscular relaxation
  • in vitro fertilization and embryo transfer(IVF-ET)
  • Couples Therapy
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 67 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Women intervention arm

    Intervention will be applied to the women within the couple.

    Behavioral: Cognitive progressive muscular relaxation therapy

  • Experimental
    Couple intervention arm

    Intervention will be applied to the couple, both men and women.

    Behavioral: Cognitive progressive muscular relaxation therapy

  • No intervention
    Control arm

    The couple will receive the normal nursing care.

Interventions

  • BehavioralCognitive 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.

06

What researchers measure

Primary outcomes

  1. 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).

  2. 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

  1. 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).

  2. 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).

  3. 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.

07

Study locations

1 site
  • Infertility Reproductive Center, Second Xiangya Hospital, Central South University
    Changsha, Hunan 410013, China
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 20, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The participants are not willing to share the data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03931187
Lead sponsor
Central South University
Responsible party
Anni Wang (Principal Investigator, Central South University) — Principal investigator
First posted
Apr 30, 2019
Start date
Dec 1, 2018
Primary completion
May 1, 2019
Completion
Jul 1, 2019
Last update
Dec 14, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion