Stress Reduction Therapy for Pregnant Women
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|ClinicalTrials.gov Identifier: NCT03404141|
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prenatal Stress||Other: Parent craft Behavioral: Cognitive-Behavioral Therapy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Psychological Therapy to Reduce Levels of Stress Among Pregnant Women|
|Estimated Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2020|
Experimental: Experimental group
The intervention administered to the experimental group will be a cognitive-behavior therapy applied by two specifically trained psychologists
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
Other: Parent craft
Midwife-guided classes for pregnant women about pregnancy and childbirth
- Change in hair cortisol levels [ Time Frame: Baseline, and 3 months ]Change in hair cortisol levels at different time points
- Change in Perceived Stress Scale (PSS) [ Time Frame: Baseline, and 3 months ]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)
- Change in Prenatal Distress Questionnaire (PDQ) [ Time Frame: Baseline, and 3 months ]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)
- Change in Symptoms Checklist 90 Revised (SCL-90-R) [ Time Frame: Baseline, and 3 months ]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.
- Change in Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Baseline, and 3 months ]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.