Psychosocial Intervention in Assisted Reproduction Treatments
Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments
1 other identifier
interventional
174
0 countries
N/A
Brief Summary
The aim of the study was to evaluate and compare different strategies of psychosocial intervention for patients undergoing IVF treatment in a private fertility clinic. Recruited patients were assigned to one of three groups: group intervention, couple intervention or no intervention (control group). Three main variables were assessed: depression, anxiety and life quality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
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
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedApril 3, 2023
March 1, 2023
4.3 years
September 17, 2020
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Depression
Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression
6 months
Anxiety
State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety
6 months
Life quality
Fertility Quality of Life (FertiQoL) scoring (spanish version). FertiQoL consists of 36 items scored according to 5 response categories. The response scale has a range of 0 to 4. Higher scores mean higher quality of life.
6 months
Secondary Outcomes (3)
Coping
6 months
Perceived social support (1)
6 months
Perceived social support (2)
6 months
Study Arms (3)
Group intervention
EXPERIMENTALCouple intervention
EXPERIMENTALNo intervention
NO INTERVENTIONInterventions
Several couples attended a total of six group psychotherapy sessions conducted by a psychologist. Between 4 and 7 couples were treated in each group session.
The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.
Eligibility Criteria
You may qualify if:
- Childless couples
- About to undergo an ART treatment
You may not qualify if:
- Undergoing ART treatment when signing the informed consent of the study
- Pregnant when signing the informed consent of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vida Recoletas Sevillalead
- IVI Madridcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
October 1, 2020
Study Start
March 25, 2015
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
April 3, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share