Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-04-05 @ 6:52 AM
Study NCT ID:
NCT04125303
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2019-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Brief Motivational Nursing Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Outcomes assesor'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-11', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-10-11', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General perception of health related quality of life EQ-5D-3L', 'timeFrame': 'At 1 month', 'description': '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.'}, {'measure': 'Health related quality of life TECVASP', 'timeFrame': 'At 1 month', 'description': 'Assessment of the Quality of Life in Psychoactive Substance Addicts Test TECVAS\n\nIt 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.'}, {'measure': 'Motivation to change', 'timeFrame': 'At 1 month', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabis', 'cocaine', 'alcohol', 'entertainment workers', 'nursing interventions'], 'conditions': ['Behavior, Addictive']}, 'referencesModule': {'references': [{'pmid': '31184429', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Checking whether changes in the perception of the quality of life related to health, after the nursing intervention, influence these patients' motivation to change. 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. First part undertook in 284 entertainmentsector workers, selected by non-probabilistic sampling, while second part undertook in 50 entertainment-business workers, selected by consecutive sampling from those who consumed substances. A short group-based motivational intervention session was implemented by nursing staff, and a before and after evaluation was completed. The EuroQol-5D and Test for the Evaluation of the Quality of Life in Addicts to Psychoactive Substances (TECVASP) were used. The patients' motivation to change was evaluated through the Stages of Change Readiness and Treatment Eagerness Scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 65 years\n* working conditions that fulfilled the Health and Safety requirements\n* acceptance of the informed consent to participation.\n* Drugs and alcohol users\n\nExclusion Criteria:\n\n* younger than 18 or older than 65\n* Non drugs and alcohol users'}, 'identificationModule': {'nctId': 'NCT04125303', 'acronym': 'BMNI', 'briefTitle': 'The Effectiveness of a Brief Motivational Nursing Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'The Effectiveness of a Brief Motivational Nursing Intervention to Reduce Psychoactive Substance Consumption in Entertainment-sector Workers: A Transversal, Observation, and Semi-experimental Study', 'orgStudyIdInfo': {'id': 'DGNRI316-06-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '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).', 'interventionNames': ['Behavioral: brief motivational psychoeducational therapy']}], 'interventions': [{'name': 'brief motivational psychoeducational therapy', 'type': 'BEHAVIORAL', 'description': "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).", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12006', 'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'University CEU Cardenal Herrera', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}], 'overallOfficials': [{'name': 'Gonzalo Haro Cortés, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad CEU cardenal Herrera-Consorcio Hospitalario Provincial de Castellón'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nursing Coordinator', 'investigatorFullName': 'Isabel Almodóvar Fernández', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}