Clinical trial NCT04572659: Psychosocial Intervention in Assisted Reproduction Treatments
Official title: Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Primary
Psychosocial Stressor
Anxiety Depression
Keywords: Assisted Reproduction Treatment (ART)
Psychology
Psychosocial intervention
Depression
Anxiety
Life quality
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
Collaborators: name: IVI Madrid
First posted: 2020-10-01
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Life quality
timeFrame: 6 months
Secondary outcomes:
measure: Coping
timeFrame: 6 months
measure: Perceived social support (1)
timeFrame: 6 months
measure: Perceived social support (2)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
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