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ImmigrantsNCT02493439

A Positive Activity Intervention to Promote Wellbeing in Romanian Immigrants

A study testing Best Possible Self and Daily Activities in people with Immigrants, run by Universitat Jaume I at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to test the efficacy of an intervention focused on promoting positive emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian immigrants living in Spain. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Immigrants
What is being tested?
Best Possible Self and Daily Activities
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteSpain
Study dates
May 2015to Nov 2015
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

  • Romanian immigrant in Spain
  • Sign a consent form stating their willingness to participate

Who cannot join

  • Presence of severe physical illness
  • Presence of severe psychological disorder
  • Be currently involved in another psychological treatment

Trial locations and contacts

1 site in 1 country.

Cristina Botella, PhD contact

+34 964 38 76 39 ext. 7639

botella@uji.es

Andreea M Dragomir-Davis, MA contact

+34 964 38 76 49 ext. 7649

andreea@uji.es

Spain1 site, 1 recruiting

  • University Jaume I

    Castellon, Castellón, 12071

    Cristina Botella, PhD, +34 964 38 76 39 ext. 7639, botella@uji.es

    Andreea M Dragomir-Davis, MA, +34 964 38 76 49 ext. 7649, andreea@uji.es

    Recruiting

Other trials in Spain

About this study

Official title: A Positive Activity Intervention to Promote Optimism and Psychological Wellbeing in Romanian Immigrants

This study aims to test the efficacy of an intervention focused on promoting positive emotions (Best Possible Self - BPS) to improve the psychological wellbeing of Romanian immigrants living in Spain. It is hypothesized that the BPS intervention will significantly improve a series of positive mental health outcomes, i.e., optimism, future expectancies, and affect, compared to the Control group.

Read the detailed description

Previous studies have shown that groups of immigrants may face a series of problems unique to the process of immigration, such as working, legal, social, and mental and physical health problems.

BPS is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. This exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population. Taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of BPS on optimism, mood and affect in an immigrant population. The design employed in this study is similar to the used in other studies.

Conditions
Immigrants
Being tested
Best Possible Self, Daily Activities
Keywords
Best Possible Self, Positive Psychology, Romanian Immigrants, Optimism, Future Thinking

What participants receive

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

  • Best Possible SelfBehavioural

  • Daily ActivitiesBehavioural

Study groups in NCT02493439
Study groupRoleWhat they receive
Best Possible SelfExperimentalParticipants are asked to write and imagine about a future in which they have reached all their goals in four different domains: personal, professional, social and health. The participants are instructed to practice the BPS intervention for a month, 5 minutes/day.
Receives: Behavioral: Best Possible Self
Daily ActivitiesPlacebo comparatorParticipants are asked to think and write about the activities carried out in the last 24 hours. The participants are instructed to practice the Daily Activities exercise for a month, 5 minutes/day.
Receives: Behavioral: Daily Activities

What is being measured

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

  1. Subjective Probability Task

    This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively)

    Measured: 1 month

Secondary outcomes (9)

  1. Positive and Negative Affect Scale

    This measure analyzes the levels of positive (PA) and negative affect (NA). The instrument consists of 20 items, 10 for each level of affect. Participants rate on a 5-point scale (Not at all - Extremely).

    Measured: 1 month

  2. Beck Depression Inventory II

    This is one of the most widely questionnaires used to evaluate severity of depression in pharmacological and psychotherapy trials. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and test-retest reliability of around 0.8.

    Measured: 1 month

  3. Overall Anxiety Severity and Impairment Scale

    OASIS is a brief instrument consisting of 5 items that measure the frequency and severity of anxiety, as well as the level of avoidance and work/school/home and social interference that anxiety produces.

    Measured: 1 month

  4. Dysfunctional Attitudes Scale

    Measured: 1 month

  5. Difficulties in Emotion Regulation Scale

    Measured: 1 month

  6. Life Orientation Test

    This scale measures positive and negative expectancies about future events. It consists of 20 statements referring to negative expectancies and 10 statements referring to positive expectancies. Participants answer on a 7-point scale (Not at all likely to occur - Extremely likely to occur). Some studies have found an appropriate levels of internal consistency for positive and negative expectancies (α=0.80-0.82 and 0.91, respectively).

    Measured: 1 month

  7. Hope Scale

    Measured: 1 month

  8. Quality of Life Index

    It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others)

    Measured: 1 month

  9. Ryff Scales of Psychological Well-Being

    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 posted9 Jul 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2015 (estimated)
  4. Study completionNov 2015 (estimated)

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02493439
Sponsor's protocol ID
UJaumeI013
Status last verified
Jul 2015
First submitted
6 Jul 2015
Last updated
15 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Meevissen YM, Peters ML, Alberts HJ. Become more optimistic by imagining a best possible self: effects of a two week intervention. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):371-8. doi: 10.1016/j.jbtep.2011.02.012. Epub 2011 Mar 2.

    PubMed 21450262

  • Peters ML, Flink IK, Boersma K, Linton SJ. Manipulating optimism: can imagining a best possible self be used to increase positive future expectancies? Journal of Positive Psychology 5: 204-211, 2010.

  • MacLeod, Byrne, & Valentine (1996). Affect, emotional disorder, and future-directed thinking. Cognition & Emotion 10: 69-86.

  • Molero, F., Recio, P., García-Ael, C., Fuster, M. J., & Sanjuán, P. (2013). Measuring dimensions of perceived discrimination in five stigmatized groups. Social indicators research, 114(3), 901-914.

  • Gonzalez-Castro JL, Ubillos S. Determinants of psychological distress among migrants from Ecuador and Romania in a Spanish city. Int J Soc Psychiatry. 2011 Jan;57(1):30-44. doi: 10.1177/0020764009347336.

    PubMed 21252354

  • Renner F, Schwarz P, Peters ML, Huibers MJ. Effects of a best-possible-self mental imagery exercise on mood and dysfunctional attitudes. Psychiatry Res. 2014 Jan 30;215(1):105-10. doi: 10.1016/j.psychres.2013.10.033. Epub 2013 Nov 1.

    PubMed 24252218

  • Sheldon, K. M., & Lyubomirsky, S. (2006). How to increase and sustain positive emotion: The effects of expressing gratitude and visualizing best possible selves. The Journal of Positive Psychology, 1(2), 73-82.

Questions about this trial

What is this clinical trial studying?

A study testing Best Possible Self and Daily Activities in people with Immigrants, run by Universitat Jaume I 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 2 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 15 Jul 2015. 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. Some participants in this study may receive a placebo. 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 Cristina Botella, PhD (+34 964 38 76 39 ext. 7639, botella@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Probability Task (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 NCT02493439, which also lists 7 linked publications.

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 15 Jul 2015.

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