Prenatal Stress Clinical Trial
Official title:
Psychological Therapy to Reduce Levels of Stress Among Pregnant Women
NCT number | NCT03404141 |
Other study ID # | Gestastress |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 2021 |
Verified date | April 2021 |
Source | Universidad de Granada |
Contact | Borja Romero |
Phone | 651048189 |
borjaromero[@]ugr.es | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prenatal stress is associated with negative outcomes such as postpartum depression, prematurity or neurodevelopmental delays. The aim of this study is to implement a psychological therapy to reduce stress during pregnancy.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Low risk Pregnant women - Gestational age between 10-27 weeks - Proficiency in the Spanish language Exclusion Criteria: - Corticoids treatment - Gestational Diabetes - Psychological diagnosed |
Country | Name | City | State |
---|---|---|---|
Spain | Granada | Churriana de la vega | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Infant neurodevelopment | Infant neurodevelopment at 6 months of age | 6 months of age | |
Primary | Change in hair cortisol levels | Change in hair cortisol levels at different time points | Baseline, and 3 months | |
Secondary | Change in Perceived Stress Scale (PSS) | The PSS provides information on the perception of general stress during the preceding month. It consists on 14 items scores on a 5-point Likert scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Scores range from 0-56 (higher scores represent higher levels of stress) | Baseline, and 3 months | |
Secondary | Change in Prenatal Distress Questionnaire (PDQ) | It is a 12-item instrument scored on a 5-point Likert scale from 0 (none at all) to 4 (extremely) to assess specific worries and concerns pregnant women experience regarding medical problems, physical symptoms, body changes, labor, childbirth, relationships, and the baby's health. Scores range from 0-48 (higher scores represent higher levels of pregnancy specific-stress) | Baseline, and 3 months | |
Secondary | Change in Symptoms Checklist 90 Revised (SCL-90-R) | This is a 90-item scale scored using a 5-point Likert scale from 0 (never) to 4 (extremely). This instrument is used to assess 9 dimensions: Somatization, Obsession-compulsion, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The scale also has 7 extra items distributed among 3 global indexes of distress: the GSI, which measures overall psychological distress; the PSDI, which is used to measure the intensity of symptoms; and Positive Symptom Total, used to measure the number of self-reported symptoms. Using the authorĀ“s instructions, the scores are transformed to percentiles (0-100). Percentiles = 70 represent clinical symptoms in any of the subscale of this instrument. | Baseline, and 3 months | |
Secondary | Change in Connor-Davidson Resilience Scale (CD-RISC) | It consists of 25 items evaluated on a 5-point Likert scale ranging from 0-4: not true at all (0), rarely true (1), sometimes true (2), often true (3), and true nearly all of the time (4) - these ratings result in a number between 0-100, and higher scores indicate higher resilience. | Baseline, and 3 months |
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