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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Spain1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Best Possible Self | Experimental | Participants 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 Activities | Placebo comparator | Participants 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.
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)
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
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
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
Dysfunctional Attitudes Scale
Measured: 1 month
Difficulties in Emotion Regulation Scale
Measured: 1 month
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
Hope Scale
Measured: 1 month
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
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.
- First posted9 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ImmigrantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azucena García-Palacios, PhD, Principal investigator, Universitat Jaume I
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 21450262Peters 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 21252354Renner 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 24252218Sheldon, 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positive Activity Intervention to Promote Optimism and Psychological Wellbeing in Romanian Immigrants
- ClinicalTrials.gov ID
- NCT02493439
- Acronym / sponsor ID
- UJaumeI013
- Conditions
- Immigrants
- Keywords
- Best Possible Self, Positive Psychology, Romanian Immigrants, Optimism, Future Thinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Possible Self | Experimental | Behavioral: Best Possible SelfParticipants 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. |
| Daily Activities | Placebo comparator | Behavioral: Daily ActivitiesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Romanian immigrant in Spain
- Sign a consent form stating their willingness to participate
Key exclusion criteria (3 listed)
- Presence of severe physical illness
- Presence of severe psychological disorder
- Be currently involved in another psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Possible Self | Behavioural | Best Possible Self |
| Daily Activities | Behavioural | Daily Activities |
Primary outcome
Subjective Probability Task
Time frame: 1 month
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)
9 secondary outcomes
Positive and Negative Affect Scale
Time frame: 1 month
Beck Depression Inventory II
Time frame: 1 month
Overall Anxiety Severity and Impairment Scale
Time frame: 1 month
Dysfunctional Attitudes Scale
Time frame: 1 month
Difficulties in Emotion Regulation Scale
Time frame: 1 month
Life Orientation Test
Time frame: 1 month
Hope Scale
Time frame: 1 month
Quality of Life Index
Time frame: 1 month
Ryff Scales of Psychological Well-Being
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Background: PubMed 21450262Meevissen 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.
- BackgroundPeters 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.
- BackgroundMacLeod, Byrne, & Valentine (1996). Affect, emotional disorder, and future-directed thinking. Cognition & Emotion 10: 69-86.
- BackgroundMolero, 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.
- Background: PubMed 21252354Gonzalez-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.
- Background: PubMed 24252218Renner 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.
- BackgroundSheldon, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azucena García-Palacios, PhD principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.