Psychosocial Intervention in Assisted Reproduction Treatments

IVI Sevilla

Status: Completed

Conditions: Anxiety Depression; Infertility Primary; Psychosocial Stressor

Treatments: Other: Group psychosocial intervention; Other: Couple psychosocial intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04572659

PSYCHOSOCIAL_ART

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

174 participants in 3 patient groups

Group intervention

Experimental group

Treatment:

Other: Group psychosocial intervention

Couple intervention

Experimental group

Treatment:

Other: Couple psychosocial intervention

No intervention

No Intervention group