NCT04816032

Brief Summary

Migration is a global phenomenon that produces several psychological impacts on the migrant causing psychological changes and difficulties such as the development of psychological diseases, the decrease of the life expectancy, insecurity, isolation, and poorness. These diseases create a situation of emergency that has prompted the need to intervene with specific psychological treatments. This study proposed to verify the effectiveness of expressive writing on the elaborative processes of the migratory journey's trauma. Participants were twenty-eight migrants of a reception center. A blinded randomized controlled trial was performed to divide them into three groups: an experimental sample that performed the expressive writing treatment, a neutral sample that performed the neutral description writing, and a control sample. The samples were assessed in three times through self-report measures. The administration of expressive writing is expected to improve the psychological health condition of migrants

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 18, 2021

Last Update Submit

March 25, 2021

Conditions

Keywords

expressive writing treatment psychological health migrants

Outcome Measures

Primary Outcomes (1)

  • psychological health of the migrants assessed with Symptom Check-List Revised. A self-report questionnaire that assess the psychological and psychopathological dimensions

    Specifically, the somatization and in general, the global psychological functioning. The Symptom Check-List Revised Scale was a self-report questionnaire that measures psychological and psychopathological issues in clinical and non-clinical populations. It is composed from 90 items. Higher scores show the presence of psychopathological symptomology and psychological complications. The range of scores are less 45 more 75 with cut-off 55. It is composed by different dimensions.

    1 month

Secondary Outcomes (1)

  • Hope for the future, assessed with Beck Hopelessness Scale, self-report questionnaire

    1 month

Study Arms (3)

Pennebaker's expressive writing

EXPERIMENTAL

Three consecutive days for 20 minutes daily of expressive writing. The topic of the traumatic traveling experience, focalizing the attention on the deeper emotions, thoughts, and feelings.

Other: Pennebaker's expressive writing intervention

Writing about different aspects of their knowledge

ACTIVE COMPARATOR

Three consecutive days for 20 minutes daily of neutral writing. Different topics of own knowledge Description of the city, their room, their place where they live, or easy procedure like, how to make a coffee (or something else), their population, trying to remain free from deep emotions, thoughts, or feelings.

Other: Neutral writing

Control

NO INTERVENTION

No intervention

Interventions

It focuses on the emotional aspect of the written event

Pennebaker's expressive writing

Description of neutral topics with less emotional involvement

Writing about different aspects of their knowledge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years and the refugees or asylum seekers status

You may not qualify if:

  • psychiatric or neurologic diagnosis and drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carlo Lai Professor PhD

Roma, Rm, 00185, Italy

Location

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

Rome, 00185, Italy

Location

Related Publications (1)

  • Begotaraj E, Sambucini D, Ciacchella C, Pellicano GR, Pierro L, Wamser-Nanney R, Aceto P, De Paola C, Caroppo E, Lai C. Effectiveness of the expressive writing on the psychological distress and traumatic symptoms of the migrants: A prospective study multiarm randomized controlled trial. Psychol Trauma. 2023 Jul;15(5):738-747. doi: 10.1037/tra0001308. Epub 2022 Sep 29.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Carlo Lai, Professor

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 25, 2021

Study Start

November 2, 2017

Primary Completion

March 15, 2018

Study Completion

July 30, 2018

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

The data was collected and stored by the Dynamics department and clinical psychology laptop, protected by a password. The data are accessible only to the Chief Researcher, the Ph.D. student, and the secondary researcher. The study protocol will be shared with other sub-investigators involved in the study, but not sensitive data. The study report will be shared and published in a scientific journal, but the privacy of each participant will be respected according to the agreements established by the ethics committee.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
24 months
Access Criteria
The sensitive data are collected in an excel database on the department of Dynamic and Clinical psychology laptop, protected by a password. Each participant is identified by a personal numerical code, to guarantee them their privacy. All the sensitive data will be accessible only by the Chief investigator, the Ph.D. student, and the sub-investigator co-responsible for the study

Locations