Stress Reduction Therapy for Pregnant Women

NCT03404141 | Unknown DMC

• 1 other identifier: Gestastress
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prenatal Stress

Keywords

Stress; pregnancy; psychological therapy; cortisol

Outcome Measures

Primary Outcomes (1)

• Change in hair cortisol levels

  Change in hair cortisol levels at different time points

  Baseline, and 3 months

Secondary Outcomes (4)

• Change in Perceived Stress Scale (PSS)

  Baseline, and 3 months

• Change in Prenatal Distress Questionnaire (PDQ)

  Baseline, and 3 months

• Change in Symptoms Checklist 90 Revised (SCL-90-R)

  Baseline, and 3 months

• Change in Connor-Davidson Resilience Scale (CD-RISC)

  Baseline, and 3 months

Other Outcomes (1)

• Infant neurodevelopment

  6 months of age

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Parent craft OTHER

Midwife-guided classes for pregnant women about pregnancy and childbirth

Control group

Cognitive-Behavioral Therapy BEHAVIORAL

Cognitive-Behavioral Therapy to reduce stress levels among pregnant women

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low risk Pregnant women
• Gestational age between 10-27 weeks
• Proficiency in the Spanish language

You may not qualify if:

• Corticoids treatment
• Gestational Diabetes
• Psychological diagnosed

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Granada

Churriana de la Vega, Granada, 18194, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 32485622 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Borja Romero

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Borja Romero

CONTACT

651048189; borjaromero@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 19, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-04

Locations

ES (1)