Psychosocial Intervention in Assisted Reproduction Treatments
- Conditions
- Infertility PrimaryAnxiety DepressionPsychosocial Stressor
- Interventions
- Other: Group psychosocial interventionOther: Couple psychosocial intervention
- Registration Number
- NCT04572659
- Lead Sponsor
- IVI Sevilla
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Childless couples
- About to undergo an ART treatment
- Undergoing ART treatment when signing the informed consent of the study
- Pregnant when signing the informed consent of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group intervention Group psychosocial intervention - Couple intervention Couple psychosocial intervention -
- Primary Outcome Measures
Name Time Method Depression 6 months Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression
Anxiety 6 months State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety
Life quality 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 Outcome Measures
Name Time Method Coping 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.
Perceived social support (1) 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.
Perceived social support (2) 6 months Interpersonal Evaluation List (ISEL). Multi- dimensional inventory measuring perceived social support in 40-items