Stress Reduction Therapy for Pregnant Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

Conditions
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Prenatal Stress

Intervention / Treatment
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* Other: Parent craft
* Behavioral: Cognitive-Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* Cognitive-Behavioral Therapy to reduce stress levels among pregnant women<br>|
| Active Comparator: Control group<br>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<br>* Midwife-guided classes for pregnant women about pregnancy and childbirth<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, pregnancy, psychological therapy, cortisol