NCT04125303

Brief Summary

This was a two-staged study undertaken in entertainment-sector workers in Spain: the first part was transversal and observational, and the second was semi-experimental. A short group-based motivational intervention session was implemented by nursing staff, and a before and after evaluation was completed. By reducing the patients' perception of their quality of life, this brief nursing intervention facilitated a favourable increase in the motivation for change among these workers and was effective in 12% of cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

September 30, 2019

Last Update Submit

October 11, 2019

Conditions

Keywords

cannabiscocainealcoholentertainment workersnursing interventions

Outcome Measures

Primary Outcomes (3)

  • General perception of health related quality of life EQ-5D-3L

    Health related quality of life (HRQL) meassured by EQ-5D (EuroQuol) The EQ-5D-3L descriptive system comprises the following 5 dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/disconfort and anxiety/depression. Each dimension has 3 respnse levels of severity: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropiate response level of each five dimensions.

    At 1 month

  • Health related quality of life TECVASP

    Assessment of the Quality of Life in Psychoactive Substance Addicts Test TECVAS It consists of 22 items (18 positive and 4 negative \[items 15, 19, 20 and 21\]) with a graded response format of five alternatives. The response alternatives are coded with the following alternatives: a) in the positive items: nothing (5 points), little (4 points), sometimes (3 points), enough (2 points) and much (1 point); b) in the negative items: nothing (1 point), little (2 points), sometimes (3 points), enough (4 points) and much (5 points). Therefore, in each element, a higher score represents a more positive evaluation of the content, and in the test, a higher score represents a better HRQL.

    At 1 month

  • Motivation to change

    Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES Scale) SOCRATES is an experimental instrument designed to assess readiness for change in alcohol and drugs abusers. The instrument yields three factorially-derived scale scores: Recognition (Re), Ambivalence (Am), and Taking Steps (Ts). It is a public domain instrument and may be used without special permission. The statements describes a way that the user might (or might not) feel about his/her drug use. For each statement, he/she has to circle one number from 1 to 5, to indicate how much they agree or disagree with it right now.

    At 1 month

Study Arms (1)

Intervention Group

EXPERIMENTAL

Based on NANDA diagnosis recommendations, entertainment-sector workers were asked to record their perceptions and the meaning of their substance-use problem in a diary. The intervention was subsequently designed based on brief motivational psychoeducational therapy (BMPT).

Behavioral: brief motivational psychoeducational therapy

Interventions

The brief motivational psychoeducational therapy (BMPT) it lasted an average of 90 min and followed the following structure: (i) brainstorming the concepts of health, lifestyle, and substance-use prevention; (ii) analysis of a work accident at an international rock group concert, which was used to generate (iii), a debate on consumer habits (30 min); (iv) discussion of the substance types and classifications known by the participants; (v) Prochaska and DiClemente's stages of change and (vi), the consequences of drug use (50 min); and finally, (vii) a true/false quiz used to discuss myths and beliefs about drugs (10 min).

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 65 years
  • working conditions that fulfilled the Health and Safety requirements
  • acceptance of the informed consent to participation.
  • Drugs and alcohol users

You may not qualify if:

  • younger than 18 or older than 65
  • Non drugs and alcohol users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University CEU Cardenal Herrera

Castellon, Castellón, 12006, Spain

Location

Related Publications (1)

  • Almodovar-Fernandez I, Sanchez-Thevenet P, Benito A, Baquero A, Mari-Sanmillan MI, Haro G. The effectiveness of a brief motivational nursing intervention to reduce psychoactive substance consumption in entertainment-sector workers: A transversal, observation, and semi-experimental study. Int J Ment Health Nurs. 2019 Oct;28(5):1090-1098. doi: 10.1111/inm.12620. Epub 2019 Jun 11.

    PMID: 31184429BACKGROUND

MeSH Terms

Conditions

Behavior, AddictiveMarijuana Abuse

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Gonzalo Haro Cortés, Dr

    Universidad CEU cardenal Herrera-Consorcio Hospitalario Provincial de Castellón

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Outcomes assesor
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Coordinator

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 14, 2019

Study Start

May 1, 2016

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations