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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • Barcelona, Spain, 08025
        • Santa Creu i Sant Pau Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Emotional intelligence intervention
Brief group intervention based on emotional intelligence

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Changes from baseline scores at 2-months scores
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
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.
Pre-intervention only

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Changes from baseline scores at 2-months scores
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
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.
Changes from baseline scores at 2-months scores
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.
Changes from baseline scores at 2-months scores
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
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.
Changes from baseline scores at 2-months scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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