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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.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent craft | Other | Midwife-guided classes for pregnant women about pregnancy and childbirth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hair cortisol levels | Change in hair cortisol levels at different time points | Baseline, and 3 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant neurodevelopment | Infant neurodevelopment at 6 months of age | 6 months of age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Borja Romero | Contact | 651048189 | borjaromero@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Borja Romero | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Granada | Recruiting | Churriana de la Vega | Granada | 18194 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32485622 | Derived | 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. |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Cognitive-Behavioral Therapy | Behavioral | Cognitive-Behavioral Therapy to reduce stress levels among pregnant women |
|
| 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 |