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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
Sponsor:
Information provided by (Responsible Party):
Rafael A. Caparros Gonzalez, Universidad de Granada

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.


Condition or disease Intervention/treatment Phase
Prenatal Stress Other: Parent craft Behavioral: Cognitive-Behavioral Therapy Not Applicable

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".


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in hair cortisol levels [ Time Frame: Baseline, and 3 months ]
    Change in hair cortisol levels at different time points


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Rafael A. Caparros Gonzalez, Research Assistant, pHD Candidate, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03404141     History of Changes
Other Study ID Numbers: Gestastress
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rafael A. Caparros Gonzalez, Universidad de Granada:
Stress
pregnancy
psychological therapy
cortisol