AODD and AODR DisorderMOTIVANCT02159391
The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs.
A study testing Brief Motivational Interview in people with AODD and AODR Disorder, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- AODD and AODR Disorder
- What is being tested?
- Brief Motivational Interview
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Dec 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Trauma patients who have had: 1) A road crash, 2) A sport injury, 3) Occupational accident.
- Tested positive on alcohol and/or other abuse drugs tests.
Who cannot join
- Cognitive or brain-damage that prevent assessment and Brief Motivational Interview
- Psychopathological disorders
- Residence status that prevents follow-up (residence outside of Spain, homeless).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism.
Read the detailed description
Objectives:
- To determine the efficacy of Brief Motivational Interview against an usual hospital treatment (no psychological treatment) in patients who have suffered an accident under the influence of drugs (1) to reduce risk behaviors and drug consumption and (2) to increase motivation to change behavior and risk perception.
- To investigate the mediating role of impulsive personality and decision making in the impact of Brief Motivational Interview on reduction of risk driving.
- To assess the economic viability of the results of Brief Motivational Interview through a cost-utility analysis.
- Conditions
- AODD and AODR Disorder
- Being tested
- Brief Motivational Interview
- Keywords
- Accident Prevention, Alcohol Drinking, Substance-Related Disorders, Motivational Interviewing, Adult, Humans, Intervention Studies, Recurrence, Risk Factors, Trauma Centers, Wounds and Injuries/epidemiology, Wounds and Injuries/etiology*, Wounds and Injuries/prevention & control*
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders, Recurrence, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterviewBehavioural
The Brief Motivational Interview implies an empathic interviewing style which (i) recognizes, examines and tries to resolve the patient´s ambivalence to facilitate behavioral change, (ii) promotes self-efficacy, (iii) allows flexibility in strategies, including short-term aims to reduce consumption and decrease damage linked to this consumption (like road accidents), (iv) works to reduce the patient's resistances, and (v) provides individualized feedback, if deemed appropriate, to promote recognition of the problem and cognitive restructuring.
| Study group | Role | What they receive |
|---|---|---|
| Usual Intervention | No intervention | A standard intervention will be performed by nursing staff during hospital admission. Written information about the consequences of driving under the influence of alcohol and/or drugs will be provided. No psychological intervention. |
| Brief Motivational Interview | Experimental | A Brief Motivational Interviewing will be performed during hospital admission by a psychologist experienced with this intervention. Receives: Behavioral: Brief Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk behavior
Measure with Short Driver Behaviour Questionnaire (SDBQ) and Domain-Specific Risk-Taking (DOSPERT)
Measured: Baseline, month 3.
Secondary outcomes (4)
Alcohol and Other Drug consumption
Measure with Timeline Followback (TLFB), Interview for Research on Addictive Behavior (IRAB) and Audit Test.
Measured: Baseline, month 3.
Motivation to change
Measure with SOCRATES-8
Measured: Baseline, post-intervention, month 3
Risk perception
Risk perception questionnaire, perceived risk of alcohol and drug (EDADES).
Measured: Baseline, post-intervention, month 3.
General Health
Measure with SF6D
Measured: Baseline, month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AODD and AODR DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada, Andaluz Health Service
- Responsible party
- Principal investigator, Raquel Vilar Lopez, Universidad de Granada
- Investigators
- Raquel Vilar, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159391
- Sponsor's protocol ID
- PI 0691-2013
- Other IDs
- PI-0691-2013
- Acronym
- MOTIVA
- Status last verified
- Sep 2015
- First submitted
- 6 Jun 2014
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Brief Motivational Interviewing for Trauma Patients Related to Alcohol or Other Abuse Drugs.
- ClinicalTrials.gov ID
- NCT02159391
- Acronym / sponsor ID
- MOTIVA / PI 0691-2013
- Conditions
- AODD and AODR Disorder
- Keywords
- Accident Prevention, Alcohol Drinking, Substance-Related Disorders, Motivational Interviewing, Adult, Humans, Intervention Studies, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalUniversity, hospital or other
- Collaborators
- Universidad de Granada, Andaluz Health Service
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Jun 2014 (estimated)
- 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.
The purpose of this study is to determine whether the Brief Motivational Interview will produce a significantly reduction in risk behavior than usual treatment 3 months after discharge from hospital in people who have survived a traumatism.
Detailed description
Objectives:
- To determine the efficacy of Brief Motivational Interview against an usual hospital treatment (no psychological treatment) in patients who have suffered an accident under the influence of drugs (1) to reduce risk behaviors and drug consumption and (2) to increase motivation to change behavior and risk perception.
- To investigate the mediating role of impulsive personality and decision making in the impact of Brief Motivational Interview on reduction of risk driving.
- To assess the economic viability of the results of Brief Motivational Interview through a cost-utility analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Intervention | No intervention | –A standard intervention will be performed by nursing staff during hospital admission. Written information about the consequences of driving under the influence of alcohol and/or drugs will be provided. No psychological intervention. |
| Brief Motivational Interview | Experimental | Behavioral: Brief Motivational InterviewA Brief Motivational Interviewing will be performed during hospital admission by a psychologist experienced with this intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Trauma patients who have had: 1) A road crash, 2) A sport injury, 3) Occupational accident.
- Tested positive on alcohol and/or other abuse drugs tests.
Key exclusion criteria (3 listed)
- Cognitive or brain-damage that prevent assessment and Brief Motivational Interview
- Psychopathological disorders
- Residence status that prevents follow-up (residence outside of Spain, homeless).
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 InterviewThe Brief Motivational Interview implies an empathic interviewing style which (i) recognizes, examines and tries to resolve the patient´s ambivalence to facilitate behavioral change, (ii) promotes self-efficacy, (iii) allows flexibility in strategies, including short-term aims to reduce consumption and decrease damage linked to this consumption (like road accidents), (iv) works to reduce the patient's resistances, and (v) provides individualized feedback, if deemed appropriate, to promote recognition of the problem and cognitive restructuring. | Behavioural | Brief Motivational Interview |
Primary outcome
Risk behavior
Time frame: Baseline, month 3.
Measure with Short Driver Behaviour Questionnaire (SDBQ) and Domain-Specific Risk-Taking (DOSPERT)
4 secondary outcomes
Alcohol and Other Drug consumption
Time frame: Baseline, month 3.
Motivation to change
Time frame: Baseline, post-intervention, month 3
Risk perception
Time frame: Baseline, post-intervention, month 3.
General Health
Time frame: Baseline, month 3.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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.
Raquel Vilar, PhD principal investigator
Universidad de Granada
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 Interview in people with AODD and AODR Disorder, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 2015. 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?
Results are not available in the source record.
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?
Risk behavior (time frame: Baseline, month 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2015.