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Clinical Trials/NCT03404141
NCT03404141
Unknown
N/A

Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

Universidad de Granada1 site in 1 country40 target enrollmentJune 1, 2018
ConditionsPrenatal Stress

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prenatal Stress
Sponsor
Universidad de Granada
Enrollment
40
Locations
1
Primary Endpoint
Change in hair cortisol levels
Last Updated
4 years ago

Overview

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.

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".

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Borja Romero-Gonzalez

PhD

Universidad de Granada

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in hair cortisol levels

Time Frame: Baseline, and 3 months

Change in hair cortisol levels at different time points

Secondary Outcomes

  • 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)
  • Change in Prenatal Distress Questionnaire (PDQ)(Baseline, and 3 months)
  • Change in Perceived Stress Scale (PSS)(Baseline, and 3 months)

Study Sites (1)

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