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Completed

NCT Number: NCT04572659

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.

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Key information

Conditions

Infertility Primary Anxiety Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Psychosocial Stressor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group psychosocial intervention

Other

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

Other

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

Primary outcomes

  1. Depression

    Time frame: 6 months

    Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression

  2. Anxiety

    Time frame: 6 months

    State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety

  3. Life quality

    Time frame: 6 months

    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.

Secondary outcomes

  1. Coping

    Time frame: 6 months

    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.

  2. Perceived social support (1)

    Time frame: 6 months

    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.

  3. Perceived social support (2)

    Time frame: 6 months

    Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Collaborators

  • IVI Madrid

Registry information

Official study title

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2020
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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