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Psychosocial Intervention in Assisted Reproduction Treatments

Primary Purpose

Infertility Primary, Psychosocial Stressor, Anxiety Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group psychosocial intervention
Couple psychosocial intervention
Sponsored by
IVI Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility Primary focused on measuring Assisted Reproduction Treatment (ART), Psychology, Psychosocial intervention, Depression, Anxiety, Life quality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Group intervention

    Couple intervention

    No intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Depression
    Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression
    Anxiety
    State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety
    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.

    Secondary Outcome Measures

    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.
    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.
    Perceived social support (2)
    Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items

    Full Information

    First Posted
    September 17, 2020
    Last Updated
    March 30, 2023
    Sponsor
    IVI Sevilla
    Collaborators
    IVI Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04572659
    Brief Title
    Psychosocial Intervention in Assisted Reproduction Treatments
    Official Title
    Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    March 25, 2015 (Actual)
    Primary Completion Date
    June 30, 2019 (Actual)
    Study Completion Date
    June 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IVI Sevilla
    Collaborators
    IVI Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility Primary, Psychosocial Stressor, Anxiety Depression
    Keywords
    Assisted Reproduction Treatment (ART), Psychology, Psychosocial intervention, Depression, Anxiety, Life quality

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    174 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group intervention
    Arm Type
    Experimental
    Arm Title
    Couple intervention
    Arm Type
    Experimental
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Group psychosocial intervention
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Couple psychosocial intervention
    Intervention Description
    The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.
    Primary Outcome Measure Information:
    Title
    Depression
    Description
    Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression
    Time Frame
    6 months
    Title
    Anxiety
    Description
    State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety
    Time Frame
    6 months
    Title
    Life quality
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Coping
    Description
    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.
    Time Frame
    6 months
    Title
    Perceived social support (1)
    Description
    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.
    Time Frame
    6 months
    Title
    Perceived social support (2)
    Description
    Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Psychosocial Intervention in Assisted Reproduction Treatments

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