AzTrials
AzTrials

Psychological HealthEWPHMNCT04816032

"Expressive Writing Psychological Health Migrants (EWPHM)

A study testing Pennebaker's expressive writing intervention and Neutral writing in people with Psychological Health, run by University of Roma La Sapienza at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Health
What is being tested?
Pennebaker's expressive writing intervention and Neutral writing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesItaly
Study dates
2 Nov 2017to 30 Jul 2018
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • psychiatric or neurologic diagnosis and drug abuse.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • Carlo Lai Professor PhD

    Roma, Rm, 00185

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

    Rome, 00185

Other trials in Italy

About this study

Official title: "Effectiveness of the Expressive Writing on the Somatization and Psychological Health of the Migrants: a Longitudinal Study"

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

Read the detailed description

Emigration is a global phenomenon with a significant impact in both, host countries and especially on people who decide to migrate. Italy seems to be a chosen destination for migrants, mainly due to its geographical position, as one of the European Union's border countries. Italy is mentioned as the fifth European country in Europe about the number of migrants. Currently, there are 5 million immigrants in Italy. Recent migratory flows in Italy have changed the cultural background of the main communities residing in the country. However, several studies have pointed out that the migration phenomenon is not a comfortable linear process, on the contrary, there are difficulties related to migratory traveling and the way it is carried out. Among others, the traveling experience could leave relevant marks on a psychological level. Recent studies underlie the effect of migration on the development of psychological diseases, on the loss of hope for the future that it affected the life expectancy causing insecurity, isolation, and poorness, and producing modification on the possible existing symptomatology. Moreover, the discrimination and disorientation that migrants experience while traveling and in host countries seem to have a relationship with anxiety symptoms.

Therefore, many investigations applied psychological intervention to treat the described symptomatology. The literature highlights the importance of the treatments such as cognitive-behavioral therapy, narrative exposure therapy, dynamic therapy, combined psychological treatments, and combined psychological with pharmacological treatments. Of the mentioned treatments, the narrative exposure treatment seems to be the less applied intervention, a meta-analysis suggested a fairly effective application of NET on populations with trauma, however, this result must be taken with caution. The NET is a trauma-focused therapy, based on trauma expositions in an autobiographical context. This treatment provides both verbal and non-verbal application, as the expressive writing-EW. Additionally, Pennebaker considered that expressive writing referring to the own traumatic events with emotional descriptions could be of help in the resolution of the own life narrations and the insert of own memories in life history. The expressive writing technique applies to the own serious traumatic events, from 3 to 5 consecutive days, for 15 minutes daily. This technique is more structured compare to NET which can be both written and oral and doesn't necessarily provide a brief exposition. The expressive writing is applied in a more extended context of trauma, violence, war, natural catastrophe, cancer, and torture. Currently in literature, there not seem to be any authoritative studies that have applied the expressive writing technique to the trauma of the migratory journey. The present investigation allows extending the acknowledgment of this treatment applied to a population of adult migrants submitted to forced migration.

The aim of this study was to provide evidence of the effectiveness of expressive writing on mental and physical health in migrants considering the mediation role of the hope for the future. The hypothesis was that migrants who performed an expressive writing treatment will show a decrease in symptomatology in association with a greater sense of hope for the future.

The study involved three different samples: experimental, neutral, and control group. The three samples were composed through a randomized controlled trial placing 22 participants for each sample. The random allocation of participants within the three samples was blindly performed.

The non-profit association "Medihospes" located in Rome provided the migrant participants. Each participant was invited to read and accept the study by completing and signing the informed consent form. The inclusion criteria were age >18 years and the refugees' or asylum seekers' status. The exclusion criteria were psychiatric or neurologic diagnosis and drug abuse.

The study was settled in three different times. At T0 time were administered a self-report questionnaires' battery composed of four measures: Beck Hopelessness Scale, BHS, Toronto Alexithymia Scale 20, TAS-20, Symptom Check-List Revised, SCL-90-R, Impact of Event Scale-Revised, IES-R.

After this first assessment, the participants of the experimental sample received the expressive writing Pennebaker's treatment, the participants of the neutral sample received instructions of writing on a general topic of their choice and the participants of the control sample received no treatment or instructions.

After one week to the treatment phase (T1) and after one month from T1 time (T2) the same self-report questionnaire's battery was administered to all the participants.

Treatment Pennebaker's expressive writing was applied for three consecutive days for 20 minutes daily. The participants of the experimental sample were asked to write about the traumatic traveling experience, focalizing the attention on the deeper emotions, thoughts, and feelings.

The participants of the neutral sample were asked to write about different topics of their knowledge for three consecutive days for 20 minutes daily; the topics could relate the description of the city, their room, their place where they live, or easy procedure like, how to make a coffee (or something else), or to describe their population, trying to remain free from deep emotions, thoughts or feelings.

Being tested
Pennebaker's expressive writing intervention, Neutral writing
Keywords
expressive writing treatment psychological health migrants
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pennebaker's expressive writing interventionOther

    It focuses on the emotional aspect of the written event

  • Neutral writingOther

    Description of neutral topics with less emotional involvement

Study groups in NCT04816032
Study groupRoleWhat they receive
Pennebaker's expressive writingExperimentalThree 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.
Receives: Other: Pennebaker's expressive writing intervention
Writing about different aspects of their knowledgeActive comparatorThree 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.
Receives: Other: Neutral writing
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month

Secondary outcomes (1)
  1. Hope for the future, assessed with Beck Hopelessness Scale, self-report questionnaire

    The outcome was assessed with Beck Hopelessness Scale. The scale is a self-report that quantifiy the hopelessness within three specific subscales (future, motivation, and expectation). Higher score means higher greater loss of hope for the future. The range of the scores are 0-20 with cut-off 9 (moderate loss of hope)

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start2 Nov 2017
  3. Primary completion15 Mar 2018
  4. Study completion30 Jul 2018

Resources

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
Single blind
Who is masked
Participant
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816032
Sponsor's protocol ID
URomLS_3
Acronym
EWPHM
Status last verified
Mar 2021
First submitted
18 Mar 2021
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36174151

Questions about this trial

What is this clinical trial studying?

A study testing Pennebaker's expressive writing intervention and Neutral writing in people with Psychological Health, run by University of Roma La Sapienza at 2 sites in Italy.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

psychological health of the migrants assessed with Symptom Check-List Revised. A self-report questionnaire that assess the psychological and psychopathological dimensions (time frame: 1 month). 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 NCT04816032, 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 30 Mar 2021.

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