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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2021
Source Universidad de Granada
Contact Borja Romero
Phone 651048189
Email borjaromero@ugr.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Objective: To assess whether the group of pregnant women have lower levels of stress after attending the psychological therapy than the group attending parent craft classes. The cognitive-behavioural therapy to reduce stress will be held in 10 sessions (1 per week) as follows: First session: General information about pregnancy. Pregnant women will describe what can they do to reduce stress levels. Second session: Breathing techniques and talk about how last week went. Third session: Muscle relaxation and guided imagination techniques Fourth session: Cognitive restructuring. Being able to detect thoughts and feelings Fifth session: Detect cognitive distortions Sixth session: Cognitive restructuring Seventh session: Time management Eighth session: Problems solving Ninth session: Assertively and social skills Tenth session: How to ask for help when needed and learning to say "No".


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Parent craft
Midwife-guided classes for pregnant women about pregnancy and childbirth
Behavioral:
Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy to reduce stress levels among pregnant women

Locations

Country Name City State
Spain Granada Churriana de la vega Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

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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