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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02493439
Other study ID # UJaumeI013
Secondary ID
Status Recruiting
Phase N/A
First received July 6, 2015
Last updated July 14, 2015
Start date May 2015
Est. completion date November 2015

Study information

Verified date July 2015
Source Universitat Jaume I
Contact Cristina Botella, PhD
Phone +34 964 38 76 39
Email botella@uji.es
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Romanian immigrant in Spain

- Sign a consent form stating their willingness to participate

Exclusion Criteria:

- Presence of severe physical illness

- Presence of severe psychological disorder

- Be currently involved in another psychological treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Best Possible Self

Daily Activities


Locations

Country Name City State
Spain University Jaume I Castellón de la Plana Castellón

Sponsors (1)

Lead Sponsor Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

References & Publications (7)

González-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: 10.1177/0020764010347336. — View Citation

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

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. — View Citation

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.

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.

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Other Self Concordance Motivation This questionnaire assess extrinsic and intrinsic motivation to practice the imagery exercise, rated on a 9-point scale ranging from 1 "not at all for this reason" to 9 "completely for this reason". SCM has been correlated withparticipants' frequency of practicing a daily imagery exercise and with self-reported imagery performance, a key aspect in self-applied interventions. baseline No
Other Multidimensional Scale of Perceived Discrimination This scale is made up of 20 items that measure four aspects of perceived discrimination: blatant group discrimination, subtle group discrimination, blatant individual discrimination and subtle individual discrimination. baseline No
Other Social Support This scale is an adapted version of the questionnaire designed by Gonzalez-Castro and Ubillos (2011). This questionnaire measures the social support received from other Romanians in Spain and from the Spanish people, in three areas: tangible social support (support in leisure activities), emotional support (care, love) and informational and instrumental support (help in addressing problems). In addition, the questionnaire measures the support received from those who live in the country of origin of the immigrant (1 = never receives support, 4 = receives a lot of support). baseline No
Primary 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 (a=0.80-0.82 and 0.91, respectively) 1 month No
Secondary 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). 1 month No
Secondary 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. 1 month No
Secondary 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. 1 month No
Secondary Dysfunctional Attitudes Scale 1 month No
Secondary Difficulties in Emotion Regulation Scale 1 month No
Secondary 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 (a=0.80-0.82 and 0.91, respectively). 1 month No
Secondary Hope Scale 1 month No
Secondary 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) 1 month No
Secondary Ryff Scales of Psychological Well-Being 1 month No