MedDataX Logo

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

NCT ID: NCT03931187

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women intervention arm

Intervention will be applied to the women within the couple.

Group Type EXPERIMENTAL

Cognitive progressive muscular relaxation therapy

Intervention Type 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.

Couple intervention arm

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

Group Type EXPERIMENTAL

Cognitive progressive muscular relaxation therapy

Intervention Type 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.

Control arm

The couple will receive the normal nursing care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central South University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anni Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Infertility Reproductive Center, Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38647487 (View on PubMed)

Chen 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.

Reference Type DERIVED
PMID: 38056467 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Intervention on IVF-ET

Identifier Type: -

Identifier Source: org_study_id