Stress Reduction Therapy for Pregnant Women

Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Prenatal Stress
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy; Other: Parent craft

Detailed 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".

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Borja Romero; Phone Number: 651048189; Email: borjaromero@ugr.es

Study Locations

• Spain
  • Granada
    • Churriana de la vega, Granada, Spain, 18194
      • Recruiting
      • Granada
      • Contact: Borja Romero; Phone Number: 651048189; Email: borjaromero@ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; The intervention administered to the experimental group will be a cognitive-behavior therapy applied by two specifically trained psychologists. Due to COVID-19 pandemic, this group will be implemented online using a videocall online platform (from April 2019 to the end of mobility restrictions).	Behavioral: Cognitive-Behavioral Therapy; Cognitive-Behavioral Therapy to reduce stress levels among pregnant women
ACTIVE_COMPARATOR: Control group; The intervention administered to the control group will consist on a regular parent craft classes offered by the community midwife Due to COVID-19 pandemic, this group will be implemented online using a videocall online platform (from April 2019 to the end of mobility restrictions).	Other: Parent craft; Midwife-guided classes for pregnant women about pregnancy and childbirth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hair cortisol levels	Change in hair cortisol levels at different time points	Baseline, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant neurodevelopment	Infant neurodevelopment at 6 months of age	6 months of age

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Borja Romero, Universidad de Granada

Publications and helpful links

General Publications

• Romero-Gonzalez B, Puertas-Gonzalez JA, Strivens-Vilchez H, Gonzalez-Perez R, Peralta-Ramirez MI. Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial. J Psychosom Res. 2020 Aug;135:110162. doi: 10.1016/j.jpsychores.2020.110162. Epub 2020 May 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (ACTUAL): January 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Stress; pregnancy; cortisol; psychological therapy
• Other Study ID Numbers: Gestastress

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No