Prenatal StressNCT03404141
Stress Reduction Therapy for Pregnant Women
A study testing Parent craft and Cognitive-Behavioral Therapy in people with Prenatal Stress, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Stress
- What is being tested?
- Parent craft and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low risk Pregnant women
- Gestational age between 10-27 weeks
- Proficiency in the Spanish language
Who cannot join
- Corticoids treatment
- Gestational Diabetes
- Psychological diagnosed
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Granada
Churriana de la Vega, Granada, 18194
Borja Romero, 651048189, borjaromero@ugr.es
About this study
Official title: Psychological Therapy to Reduce Levels of Stress Among Pregnant Women
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.
Read the 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".
- Conditions
- Prenatal Stress
- Being tested
- Parent craft, Cognitive-Behavioral Therapy
- Keywords
- Stress, pregnancy, psychological therapy, cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent craftOther
Midwife-guided classes for pregnant women about pregnancy and childbirth
Cognitive-Behavioral TherapyBehavioural
Cognitive-Behavioral Therapy to reduce stress levels among pregnant women
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Cognitive-Behavioral Therapy |
| 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). Receives: Other: Parent craft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hair cortisol levels
Change in hair cortisol levels at different time points
Measured: Baseline, and 3 months
Secondary outcomes (4)
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)
Measured: Baseline, and 3 months
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)
Measured: 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.
Measured: 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.
Measured: Baseline, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jun 2018
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borja Romero-Gonzalez, Universidad de Granada
- Investigators
- Borja Romero, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404141
- Sponsor's protocol ID
- Gestastress
- Status last verified
- Apr 2021
- First submitted
- 15 Dec 2017
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32485622
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Therapy to Reduce Levels of Stress Among Pregnant Women
- ClinicalTrials.gov ID
- NCT03404141
- Acronym / sponsor ID
- Gestastress
- Conditions
- Prenatal Stress
- Keywords
- Stress, pregnancy, psychological therapy, cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Cognitive-Behavioral TherapyThe 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 | Other: Parent craftThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low risk Pregnant women
- Gestational age between 10-27 weeks
- Proficiency in the Spanish language
Key exclusion criteria (3 listed)
- Corticoids treatment
- Gestational Diabetes
- Psychological diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent craftMidwife-guided classes for pregnant women about pregnancy and childbirth | Other | Control group |
| Cognitive-Behavioral TherapyCognitive-Behavioral Therapy to reduce stress levels among pregnant women | Behavioural | Experimental group |
Primary outcome
Change in hair cortisol levels
Time frame: Baseline, and 3 months
Change in hair cortisol levels at different time points
4 secondary outcomes
Change in Perceived Stress Scale (PSS)
Time frame: Baseline, and 3 months
Change in Prenatal Distress Questionnaire (PDQ)
Time frame: Baseline, and 3 months
Change in Symptoms Checklist 90 Revised (SCL-90-R)
Time frame: Baseline, and 3 months
Change in Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Baseline, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 32485622Romero-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borja Romero principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent craft and Cognitive-Behavioral Therapy in people with Prenatal Stress, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borja Romero (651048189, borjaromero@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair cortisol levels (time frame: Baseline, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.