The Effectiveness of Expressive Writing on a Sample of New Mothers

NCT04803344 | Completed

• 1 other identifier: URomLS_2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Distress; Health Care Utilization

Outcome Measures

Primary Outcomes (5)

• Health-related quality of life

  In order to evaluate the Health-related quality of life, the 12-Item Short Form Health Survey was used. This standardized questionnaire is composed by 12 items selected from SF-36 and produces two summaries, physical (PCS) and mental (MCS) scale (Brazier and Roberts, 2004).

  Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

• Anxiety

  In order to evaluate the levels of anxiety, the Spielberger State-Trait Anxiety Inventory, STAI-Y, (Spielberger, 1983; Spielberger et al., 1970) was used. It is a self-report questionnaire developed to evaluate both state and trait anxiety, respectively a transitory emotional state and a personality trait considered relatively stable.

  Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

• Depression

  In order to evaluate the levels of depression, The 13-item short form of Beck Depression Inventory (BDI-II) was used.

  Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

• Healthcare spending

  In order to test the healthcare spending to all participants were asked (through a specific questionnaire built ad hoc for the specific situation) the number of medical visits, the number of hospitalizations, the number of admissions to emergency room for acute episodes, the number of hospitalizations stay days in the last year. The study hypothesized a lower number of medical visits, hospitalization's days and admissions to emergency room for those mothers who performed the expressive writing task.

  Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

• Stress

  In order to test the stress levels, the Valutazione Rapida dello stress (VRS) was used. The VRS is rapid self-assessment rating scale for measure of percieved stress. This scale is composed of 15 items and five areas: anxiety, depression, somatization, aggressiveness, and social support. The social support scale measures the percieved lack of social support (Tarsitani and Biondi, 1999).

  Before (T0) and after the writing intervention (T1) and at the follow-up (T2). The outcome assessment lasts about 1 hour

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Expressive Writing tecnique

Control Group

ACTIVE COMPARATOR

Behavioral: Neutral Writing

Interventions

Expressive Writing tecnique 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.

Experimental Group

Neutral Writing BEHAVIORAL

Participants were asked to write on neutral objects or events.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study was conducted on new mothers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• medical complication during pregnancy
• no comprehension of Italian language

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

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

Rome, 00185, Italy

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carlo Lai, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: March 17, 2021
• Study Start: April 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)