Psychosocial Intervention in Assisted Reproduction Treatments

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Depression; Psychosocial Stressor; Infertility Primary
• Intervention / Treatment: Other: Group psychosocial intervention; Other: Couple psychosocial intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: Group 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.
Experimental: Couple intervention	Other: Couple psychosocial intervention; The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Perceived social support (2)	Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items	6 months

Collaborators and Investigators

• Sponsor: IVI Sevilla
• Collaborators: IVI Madrid

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2015
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Psychosocial intervention; Life quality; Psychology; Assisted Reproduction Treatment (ART)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Infertility
• Other Study ID Numbers: PSYCHOSOCIAL_ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No