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
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
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
NCT ID
NCT04572659
First Posted
September 17, 2020
Last Updated
March 30, 2023
Sponsor
IVI Sevilla
Collaborators
IVI Madrid
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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