Working... Menu

Stress Reduction Therapy for Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03404141
Recruitment Status : Not yet recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
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".

Layout table for study information
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Layout table for additonal information
Responsible Party: Rafael A. Caparros Gonzalez, Research Assistant, pHD Candidate, Universidad de Granada 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

Layout table for additional information
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:
psychological therapy