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Emotional Intelligence in Patients With Addictive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521609
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date June 6, 2018
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • Change in Trait Meta-Mood Scale (TMMS-24) [ Time Frame: Changes from baseline scores at 2-months scores ]
    Assessment at pre- and post-intervention time points
  • Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) [ Time Frame: Pre-intervention only ]
    Pre-intervention assessment
Change History Complete list of historical versions of study NCT03521609 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • Change in Rosenberg Self-esteem Scale (RSES) [ Time Frame: Changes from baseline scores at 2-months scores ]
    Assessment at pre- and post-intervention time points
  • Change in Subjective Happiness Scale (SHS) [ Time Frame: Changes from baseline scores at 2-months scores ]
    Assessment at pre- and post-intervention time points
  • Change in Satisfaction with LIfe Scale (SWLS) [ Time Frame: Changes from baseline scores at 2-months scores ]
    Assessment at pre- and post-intervention time points
  • Change in State-Trait Anxiety Inventory - State subscale (STAI-S) [ Time Frame: Changes from baseline scores at 2-months scores ]
    Assessment at pre- and post-intervention time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotional Intelligence in Patients With Addictive Disorder
Official Title  ICMJE Emotional Intelligence in Patients With Addictive Disorder
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE Behavioral: Emotional intelligence intervention
Brief group intervention based on emotional intelligence
Study Arms  ICMJE 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.
Intervention: Behavioral: Emotional intelligence intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 30, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521609
Other Study ID Numbers  ICMJE IIBSP-INT-2017-106
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seyla De Francisco Prófumo, RN Fundació de Gestió Snitària de l'Hospital de la Santa Creu i Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP