NCT03521609

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

May 25, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

April 30, 2018

Last Update Submit

June 4, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in perceived emotional intelligence, measured with the Spanish version of the Trait Meta-Mood Scale (Fernandez-Berrocal, Extremera & Ramos, 2004).

    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).

    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 Outcomes (4)

  • Change in self-esteem, measured with the Spanish version of the Rosenberg Self-Esteem Scale (Martin-Albo, Núñez, Navarro & Grijalvo, 2007).

    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).

    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).

    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).

    Changes from baseline scores at 2-months scores

Study Arms (1)

Emotional Intelligence Intervention

EXPERIMENTAL

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

Interventions

Brief group intervention based on emotional intelligence

Emotional Intelligence Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Substance Use Disorder (DSM-5)
  • to 80 years old

You may not qualify if:

  • Presence of severe psychopathological alteration (including severe intoxication)
  • Inability to understand the Spanish language or difficulties writing or reading

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Creu i Sant Pau Hospital

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Seyla De Francisco Prófumo, RN

    Fundació de Gestió Snitària de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

May 25, 2018

Primary Completion

July 1, 2020

Study Completion

October 1, 2020

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations