- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03521609
Emotional Intelligence in Patients With Addictive Disorder
June 4, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
The study aims to evaluate the level of emotional intelligence in patients diagnosed with substance use disorder and to evaluate the benefits in emotional skills after a brief intervention based on emotional intelligence.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients will be recruited by consecutive non-probabilistic sampling in the Addictions Day Hospital of the Addictions Unit of the Hospital de la Santa Creu i Sant Pau in Barcelona.
The level of emotional intelligence will be assessed through the following measurement instruments: MSCEIT for the objective emotional intelligence coefficient and the TMMS-24 for the perceived emotional intelligence.
Patients will attend 9 sessions of brief group intervention based on emotional intelligence and pre-post intervention differences in participants' TMMS-24 scores will be analyzed
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Barcelona, Spain, 08025
- Santa Creu i Sant Pau Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Substance Use Disorder (DSM-5)
- 18 to 80 years old
Exclusion Criteria:
- Presence of severe psychopathological alteration (including severe intoxication)
- Inability to understand the Spanish language or difficulties writing or reading
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emotional Intelligence Intervention
Patient's emotional abilities will be stimulated by means of a brief intervention in a group format (nine sessions).
In these sessions we will use both projective and guided-fantasy techniques for the emotional diagnosis, as well as psychoeducational workshops of both emotional education and emotional intelligence development.
|
Brief group intervention based on emotional intelligence
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived emotional intelligence, measured with the Spanish version of the Trait Meta-Mood Scale (Fernandez-Berrocal, Extremera & Ramos, 2004).
Time Frame: Changes from baseline scores at 2-months scores
|
The Trait Meta-Mood Scale (TMMS-24) is a 24-item self-report instrument with three subscales measuring three key aspects of perceived emotional intelligence: Attention, Clarity and Repair.
Each of these three subscales consists of eight items with a 5-point Likert response format (ranging from 1 to 5).
Subscale total scores are obtained by summing responses to all items and thus range from 8 to 40, with higher scores indicating greater level of the characteristic assessed.
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Changes from baseline scores at 2-months scores
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Score on an ability measure of emotional intelligence, the Spanish version of the Mayer-Salovey-Caruso Emotional Intelligence Test (Extremera & Fernández-Berrocal, 2016).
Time Frame: Pre-intervention only
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The Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) consists of 141 items that yield an overall emotional intelligence (EI) score and two EI area scores: the Experiential EI and Strategic EI scores.
The aforementioned scores have a mean of 100 and a standard deviation of 15, with higher scores indicating greater emotional intelligence.
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Pre-intervention only
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-esteem, measured with the Spanish version of the Rosenberg Self-Esteem Scale (Martin-Albo, Núñez, Navarro & Grijalvo, 2007).
Time Frame: Changes from baseline scores at 2-months scores
|
The Rosenberg Self-Esteem Scale (RSES) is a self-report measure of global self-esteem.
It consists of ten items with a 4-point Likert response format (ranging from 1 to 4).
The RSES total score is obtained by summing responses to all items and thus ranges from 10 to 40, with higher scores indicating greater self-esteem.
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Changes from baseline scores at 2-months scores
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Change in subjective happiness, measured with the Spanish version of the Subjective Happiness Scale (Extremera & Fernández-Berrocal, 2013).
Time Frame: Changes from baseline scores at 2-months scores
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The Subjective Happiness Scale (SHS) is a self-report measure of global subjective happiness.
It consists of four items with a 7-point Likert response format (ranging from 1 to 7).
The SHS total score is obtained by averaging responses to all items and thus ranges from 1 to 7, with higher scores indicating greater happiness.
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Changes from baseline scores at 2-months scores
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Change in life satisfaction, measured with the Spanish version of the Satisfaction with Life Scale (Vásquez, Duque & Hervás, 2013).
Time Frame: Changes from baseline scores at 2-months scores
|
The Satisfaction with Life Scale (SWLS) is a self-report measure of life satisfaction.
It consists of five items with a 7-point Likert response format (ranging from 1 to 7).
The SWLS total score is obtained by summing responses to all items and thus ranges from 5 to 35, with higher scores indicating greater life satisfaction.
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Changes from baseline scores at 2-months scores
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Change in anxiety levels, measured with the Spanish version of the State-Trait Anxiety Inventory - State subscale (Spielberger, Gorsuch & Lushene, 2011).
Time Frame: Changes from baseline scores at 2-months scores
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The State-Trait Anxiety Inventory - State subscale (STAI-S) is a self-report measure of state anxiety.
It consists of 20 items with a 4-point Likert response format (ranging from 0 to 3).
The STAI-S total direct score is obtained by summing responses to all items and thus ranges from 0 to 60, with higher scores indicating greater levels of state anxiety.
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Changes from baseline scores at 2-months scores
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seyla De Francisco Prófumo, RN, Fundació de Gestió Snitària de l'Hospital de la Santa Creu i Sant Pau
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2018
Primary Completion (Anticipated)
July 1, 2020
Study Completion (Anticipated)
October 1, 2020
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
April 30, 2018
First Posted (Actual)
May 11, 2018
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-INT-2017-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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