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Stress Reduction Therapy for Pregnant Women

Psychological Therapy to Reduce Levels of Stress Among Pregnant Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03404141
Enrollment
40
Registered
2018-01-19
Start date
2018-06-01
Completion date
2021-12-31
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prenatal Stress

Keywords

Stress, pregnancy, psychological therapy, cortisol

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.

Interventions

OTHERParent craft

Midwife-guided classes for pregnant women about pregnancy and childbirth

BEHAVIORALCognitive-Behavioral Therapy

Cognitive-Behavioral Therapy to reduce stress levels among pregnant women

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in hair cortisol levelsBaseline, and 3 monthsChange in hair cortisol levels at different time points

Secondary

MeasureTime frameDescription
Change in Perceived Stress Scale (PSS)Baseline, and 3 monthsThe 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)Baseline, and 3 monthsIt 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)Baseline, and 3 monthsThis 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)Baseline, and 3 monthsIt 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.

Other

MeasureTime frameDescription
Infant neurodevelopment6 months of ageInfant neurodevelopment at 6 months of age

Countries

Spain

Contacts

Primary ContactBorja Romero
borjaromero@ugr.es651048189

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026