Behavior, AddictiveBMNINCT04125303
The Effectiveness of a Brief Motivational Nursing Intervention
A study testing brief motivational psychoeducational therapy in people with Behavior, Addictive, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behavior, Addictive
- What is being tested?
- brief motivational psychoeducational therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2016to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- younger than 18 or older than 65
- Non drugs and alcohol users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Brief Motivational Nursing Intervention to Reduce Psychoactive Substance Consumption in Entertainment-sector Workers: A Transversal, Observation, and Semi-experimental Study
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.
Read the detailed description
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.
- Conditions
- Behavior, Addictive
- Being tested
- brief motivational psychoeducational therapy
- Keywords
- cannabis, cocaine, alcohol, entertainment workers, nursing interventions
- Medical subject headings
- Behavior, Addictive, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief motivational psychoeducational therapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: brief motivational psychoeducational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 May 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, AddictiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Almodóvar Fernández, Cardenal Herrera University
- Investigators
- Gonzalo Haro Cortés, Dr, Study director, Universidad CEU cardenal Herrera-Consorcio Hospitalario Provincial de Castellón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125303
- Sponsor's protocol ID
- DGNRI316-06-23
- Acronym
- BMNI
- Status last verified
- Oct 2019
- First submitted
- 30 Sep 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31184429
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Brief Motivational Nursing Intervention to Reduce Psychoactive Substance Consumption in Entertainment-sector Workers: A Transversal, Observation, and Semi-experimental Study
- ClinicalTrials.gov ID
- NCT04125303
- Acronym / sponsor ID
- BMNI / DGNRI316-06-23
- Conditions
- Behavior, Addictive
- Keywords
- cannabis, cocaine, alcohol, entertainment workers, nursing interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: brief motivational psychoeducational therapyBased 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- younger than 18 or older than 65
- Non drugs and alcohol users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief motivational psychoeducational therapyThe 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). | Behavioural | Intervention Group |
Primary outcome
General perception of health related quality of life EQ-5D-3L
Time frame: At 1 month
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.
Health related quality of life TECVASP
Time frame: At 1 month
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.
Motivation to change
Time frame: At 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Background: PubMed 31184429Almodovar-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Haro Cortés, Dr study director
Universidad CEU cardenal Herrera-Consorcio Hospitalario Provincial de Castellón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief motivational psychoeducational therapy in people with Behavior, Addictive, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General perception of health related quality of life EQ-5D-3L (time frame: At 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.