Stress Reduction Therapy for Pregnant Women

Prenatal Stress Clinical Trial

Official title:

Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404141
• Other study ID #: Gestastress
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prenatal Stress

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 author´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