Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET
1 other identifier
interventional
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 14, 2021
November 1, 2021
5 months
April 23, 2019
November 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Change of Blood Cortisol
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 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 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.
Study Arms (3)
Women intervention arm
EXPERIMENTALIntervention will be applied to the women within the couple.
Couple intervention arm
EXPERIMENTALIntervention will be applied to the couple, both men and women.
Control arm
NO INTERVENTIONThe couple will receive the normal nursing care.
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
- Experiencing major traumatic events in the past 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infertility Reproductive Center, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410013, China
Related Publications (2)
Wang A, Zhang W, Li H, Guo Y, Yu NX, Zhang J. An 8-week community-based resilience group intervention for Chinese parents who lost their only child: A two-armed pragmatic waitlist-control trial. Psychol Trauma. 2025 Jan;17(1):225-234. doi: 10.1037/tra0001670. Epub 2024 Apr 22.
PMID: 38647487DERIVEDChen D, Wang A, Zhang W, Guo Y, Yao S, Chen X, Zhang J. Effectiveness of double ABCX-based psychotherapy for psychological distress among women undergoing in vitro fertilization-embryo transfer: a three-arm randomized controlled trial. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2278015. doi: 10.1080/0167482X.2023.2278015. Epub 2023 Dec 6.
PMID: 38056467DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 30, 2019
Study Start
December 1, 2018
Primary Completion
May 1, 2019
Study Completion
July 1, 2019
Last Updated
December 14, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share
The participants are not willing to share the data.