The Effectiveness of Expressive Writing on a Sample of New Mothers

NCT ID: NCT04803344

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-03-30

Brief Summary

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This pilot study aims to evaluate the effects of an expressive writing intervention on a sample of new mothers after the childbirth on the psychological health and on the healthcare costs. The mothers were evaluated also in a follow-up one month after the end of the expressive writing intervention.

Detailed Description

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Women are recruited starting from the sixth month of pregnancy; forty-one eventually agreed to participate and they were randomly assigned to two groups: an Experimental group (treated with the expressive writing task, one weeks-three months after childbirth) and a Control group (no intervention).

Psychological health is measured at three stages:

before intervention, at 8-9 months pregnant (T0); after intervention, from 1 week to 3 months after delivery (T1); and a follow-up after 1 to 3 months (T2). The assessment protocol consists of the Attachment Style Questionnaire (ASQ), the Prenatal Attachment Inventory (PAI), the Toronto Alexythimia Scale-20 (TAS-20), the Beck Depression Inventory (BDI-13), the State-Trait Anxiety Inventory (STAI-Y), the Rating Scale For Rapid Stress Assessment (VRS) and the 12-Item Short Form Survey (SF-12). The healthcare costs are collected at baseline (T0) and follow-up (T2) with a survey created ad hoc, in which participants reported the number and the type of the medical examinations, hospitalisations, prescribed drugs etc. Social and personal data are collected from the first survey.

Conditions

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Maternal Distress Health Care Utilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Group

After the childbirth, writing group participants has been asked to write for 3 consecutive days, 20 minutes each days, all the deepest emotions and feelings related to the pregnancy.

Group Type EXPERIMENTAL

Expressive Writing tecnique

Intervention Type BEHAVIORAL

Expressive Writing (EW), is a simple, potentially inexpensive, therapeutic intervention which involves writing daily for 15-20 min over 3-4 consecutive days. EW can be completed at home without the need for facilitation, a specialist therapist or a dedicated facility.

Control Group

Group Type ACTIVE_COMPARATOR

Neutral Writing

Intervention Type BEHAVIORAL

Participants were asked to write on neutral objects or events.

Interventions

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Expressive Writing tecnique

Expressive Writing (EW), is a simple, potentially inexpensive, therapeutic intervention which involves writing daily for 15-20 min over 3-4 consecutive days. EW can be completed at home without the need for facilitation, a specialist therapist or a dedicated facility.

Intervention Type BEHAVIORAL

Neutral Writing

Participants were asked to write on neutral objects or events.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years
* \> 6 months of pregnancy
* no medical complications during pregnancy

Exclusion Criteria

* medical complication during pregnancy
* no comprehension of Italian language
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Carlo Lai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Lai, Professor

Role: PRINCIPAL_INVESTIGATOR

Sapienza university of Rome, Department of Dynamic and Clinical Psychology, and Health Studies

Locations

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Department of Dynamic and Clinical Psychology, and Health Studies, Sapienza University

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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URomLS_2

Identifier Type: -

Identifier Source: org_study_id

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