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Clinical Trials/NCT04572659
NCT04572659
Completed
N/A

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

IVI Sevilla0 sites174 target enrollmentMarch 25, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infertility Primary
Sponsor
IVI Sevilla
Enrollment
174
Primary Endpoint
Depression
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

A total of 87 couples have participated in this study. All couples were about to start an assisted reproduction treatment (artificial insemination or in vitro fertilization). Couples were assigned to one of three study groups: group intervention, couple intervention or no intervention (control group). Patients in the first group (group intervention) attended six group psychotherapy sessions. Patients in the second group attended six psychotherapy sessions (particular sessions in this case). The patients in the third group received no psycho-social intervention. Assignation to each group was not randomized, it depended on scheduling availability of the patients. Patients attended one session every week or 15 days. Each session lasted 90 minutes. Sessions were designed to minimize the possible negative psycho -social impact of infertility and its treatment. Different aspects were approached in these sessions including emotion expression, social coping, communication skills, emotion management in different social situations, identification of dysfunctional thoughts, cognitive restructuring, and cognitive distortions. The outcomes measured were: anxiety, depression, life quality, coping and perceived social support. These variables were assessed before ART, after ART and in a follow-up performed six months after ART. Psychological variables were assessed using different well-recognized inventories.

Registry
clinicaltrials.gov
Start Date
March 25, 2015
End Date
June 30, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
IVI Sevilla
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Childless couples
  • About to undergo an ART treatment

Exclusion Criteria

  • Undergoing ART treatment when signing the informed consent of the study
  • Pregnant when signing the informed consent of the study

Outcomes

Primary Outcomes

Depression

Time Frame: 6 months

Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression

Anxiety

Time Frame: 6 months

State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety

Life quality

Time Frame: 6 months

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.

Secondary Outcomes

  • Coping(6 months)
  • Perceived social support (1)(6 months)
  • Perceived social support (2)(6 months)

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