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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03931187
Enrollment
67
Registered
2019-04-30
Start date
2018-12-01
Completion date
2019-07-01
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

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

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.

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.

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders; * Experiencing major traumatic events in the past 2 years.

Design outcomes

Primary

MeasureTime frameDescription
Change of depression scoreThe 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.
Change of anxiety scoreThe 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

MeasureTime frameDescription
Change of Blood CortisolThe 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.
Change of sleeping qualityThe 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.
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.The investigators will count the successful conception rate at each arms.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026