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Psychosocial Intervention in Assisted Reproduction Treatments

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04572659
Enrollment
174
Registered
2020-10-01
Start date
2015-03-25
Completion date
2019-06-30
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Depression, Infertility Primary, Psychosocial Stressor

Keywords

Assisted Reproduction Treatment (ART), Psychology, Psychosocial intervention, Depression, Anxiety, Life quality

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.

Interventions

OTHERGroup 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.

OTHERCouple psychosocial intervention

The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.

Sponsors

IVI Madrid
CollaboratorOTHER
Vida Recoletas Sevilla
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression6 monthsBeck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression
Anxiety6 monthsState-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety
Life quality6 monthsFertility 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

MeasureTime frameDescription
Coping6 monthsCoping 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.
Perceived social support (1)6 monthsMultidimensional 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.
Perceived social support (2)6 monthsInterpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026