Psychosocial Intervention in Assisted Reproduction Treatments

Anxiety Depression Clinical Trial

Official title:

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572659
• Other study ID #: PSYCHOSOCIAL_ART
• Status: Completed
• Phase: N/A
• Start date: March 25, 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2023
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Depression
• Depression
• Infertility
• Infertility Primary
• Psychosocial Stressor

Intervention

Other:
• Group psychosocial intervention
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.
• Couple psychosocial intervention
The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
IVI Sevilla	IVI Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Anxiety	State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety	6 months
Primary	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	Coping	Coping Orientation to Problems Experienced (COPE) inventory. 28 item self-report questionnaire. The scale can determine someone's primary coping styles with scores on the following three subscale: Problem-Focussed Coping, Emotion-Focussed Coping, and Avoidant Coping.	6 months
Secondary	Perceived social support (1)	Multidimensional Scale of Perceived Social Support (MSPSS). 12-item measure of perceived adequacy of social support from three sources: family, friends, & significant other; using a 5-point Likert scale.	6 months
Secondary	Perceived social support (2)	Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items	6 months