Substance Use DisordersNCT06223191
Reducing Readmissions: BNI Trial in Substance Use Disorder
A study testing Brief Negotiated Interview and Narrative Interview in people with Substance Use Disorders and Substance Withdrawal, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial summary
The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use Disorders, Substance Withdrawal
- What is being tested?
- Brief Negotiated Interview and Narrative Interview
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHonduras
- Study dates
- 29 Jan 2024to 15 Sep 2024
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 18 or older who are hospitalized in the Alcohol Detoxification Unit during the period of January to March of 2024
- Patients with a score on the AUDIT scale greater than 15.
- Patients with a score equal to or greater than 4 for any substance on the World Health Organization-ASSIST.
- Patients from the Alcohol Detoxification Unit who provide their consent to participate in the study.
Who cannot join
- Patients with a score on the AUDIT scale less than 15.
- Patients with a score on the WHO-ASSIST scale for substances less than 4.
- Patients from the Alcohol Detoxification Unit who do not provide their consent to participate in the study.
- Patients from the Alcohol Detoxification Unit diagnosed with Delirium Tremens, Acute Intoxication of any substance, or conditions that alter consciousness.
- Patients from the Alcohol Detoxification Unit diagnosed with intellectual disability documented in the medical records.
- Female patients.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Facultad de Ciencias Medicas
Tegucigalpa, Francisco Morazán Department
About this study
Official title: Comparing Brief Negotiated Interview, Narrative Interview, and Standard Care to Reduce Readmission: A 2024 Clinical Trial in Substance Use Disorder Patients at Santa Rosita Psychiatric Specialties Hospital
The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief Negotiated Interview reduces rehospitalization rates at least to 50%? Participants will be submitted to a Structured interview with motivational interviewing techniques. Researchers will compare 2 control groups one with standards of care and the other one with a narrative interview to see if they reduce readmission.
Read the detailed description
The research investigates the effectiveness of the Brief Negotiated Interview (BNI) compared to Narrative Interview and Standards of Care in reducing readmissions among patients with Substance Use Disorder (SUD) in the Alcoholic Detoxification Unit of Santa Rosita Psychiatric Specialties Hospital in 2024. Employing a randomized clinical trial design, the study aims to address a critical gap in understanding the optimal intervention for this vulnerable population.
Study Design: This trial adopts a prospective, randomized, three-arm design, with participants randomly assigned to one of three groups: BNI, Narrative Interview, or Standard Care. The randomization process utilizes a computer-generated list, ensuring an allocation ratio of 1:1:1. The trial encompasses a recruitment period of three months, followed by a three-month follow-up period.
Participants: The target population comprises 150 male patients aged 18 or older admitted to the Alcoholic Detoxification Unit during January 2024.
Interventions:
Brief Negotiated Interview (BNI): Modeled after motivational interviewing techniques, BNI aims to empower patients to explore reasons for change. Administered as a single 30-minute session, BNI encourages patient autonomy in decision-making regarding behavioral changes related to substance use.
Narrative Interview: A 20-minute session applying narrative therapy techniques, encouraging patients to explore and reframe their stories concerning substance use. The session emphasizes externalizing issues and examining social and political factors contributing to the problem.
Standard Care: Following the Alcohol Detoxification Management Protocol, standard care includes pharmacological interventions (benzodiazepines, thiamine, etc.), psychological evaluation on the third day, psychoeducational sessions, and psychiatric assessment for dual diagnoses.
Outcomes: Primary outcomes involve measuring rehospitalization rates at three months, time to relapse, reduction in substance consumption, and changes in depressive and anxious symptoms.
Statistical Analysis:Descriptive statistics will characterize nominal and categorical variables. For continuous variables, means and standard deviations will be calculated. Chi-square tests will assess the relationship between rehospitalization and intervention groups. Risk ratios and incidence rates will be computed to determine the relative risk of readmission.
Ethical Considerations: The study adheres to CONSORT guidelines, receiving approval from the Institutional Review Board. Informed consent is obtained from all participants, ensuring comprehension of the study's purpose, risks, and benefits. Confidentiality is maintained, and participants are informed of their right to withdraw without interference in their clinical care.
Conclusion: This comprehensive research design integrates rigorous methodology, ethical considerations, and a tailored intervention approach to address the multifaceted challenges faced by patients with SUD. The outcomes are expected to contribute valuable insights to the field, guiding evidence-based practices for enhanced patient outcomes and reduced readmission rates
- Conditions
- Substance Use Disorders, Substance Withdrawal
- Being tested
- Brief Negotiated Interview, Narrative Interview
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Negotiated InterviewOther
The BNI is a specialized "brief intervention" for the medical setting, has foundations in motivational interviewing techniques. The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. The BNI is in the form of an algorithm, or "script", that guides providers through the health intervention with carefully phrased key questions and responses, all at the providers' fingertips
Narrative InterviewOther
The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions.
| Study group | Role | What they receive |
|---|---|---|
| Brief Negotiated Interview | Experimental | The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. Instead of telling the patient what changes he/she should make, the BNI is intentionally designed to elicit reasons for change and action steps from the patient. It gives the patient voice and choice, making any potential behavior changes all the more empowering to the patient. Receives: Other: Brief Negotiated Interview |
| Narrative Interview | Placebo comparator | The Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions. Receives: Other: Narrative Interview |
| Standards of Care | No intervention | This arm includes the use of benzodiazepines (Diazepam or Lorazepam) when CIWA-Ar scale is ≥9. Other medications may include Thiamine, Potassium Chloride, oral rehydration salts, parenteral fluids, antiemetics, and gastric protectants if medically necessary. Patients undergo a psychological evaluation on the third day of admission. All patients receive at least one psychoeducational session on alcohol and substance use during their hospitalization. Psychiatric evaluation is available for those with dual diagnoses such as mood disorders, anxiety disorders, psychotic disorders, or multiple substance use. The total hospitalization time in the ward is 8 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission Rate
Measurement of the readmissions rate at 3 months from the study's initiation. This could be a key indicator to assess the impact of interventions on relapse prevention.
Measured: 3 months
Risk Rate of Readmission
Measurement of the risk rate through the ratio of the readmission rate treatment group and the control group rate
Measured: 3 months
Secondary outcomes (1)
HADS Score
Assessment of the presence of depressive and anxious symptoms in patients with substance use. Through HADS ScaleThis primary outcome would directly address the participants' mental health as a result of the interventions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start29 Jan 2024
- Primary completion22 May 2024
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Manuel Rosales Gomez, Universidad Nacional Autonoma de Honduras
- Investigators
- Carlos M. Rosales, MD, Principal investigator, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223191
- Sponsor's protocol ID
- BNIReadmissions
- Status last verified
- May 2024
- First submitted
- 21 Dec 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Brief Negotiated Interview, Narrative Interview, and Standard Care to Reduce Readmission: A 2024 Clinical Trial in Substance Use Disorder Patients at Santa Rosita Psychiatric Specialties Hospital
- ClinicalTrials.gov ID
- NCT06223191
- Acronym / sponsor ID
- BNIReadmissions
- Conditions
- Substance Use Disorders, Substance Withdrawal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief Negotiated Interview reduces rehospitalization rates at least to 50%? Participants will be submitted to a Structured interview with motivational interviewing techniques. Researchers will compare 2 control groups one with standards of care and the other one with a narrative interview to see if they reduce readmission.
Detailed description
The research investigates the effectiveness of the Brief Negotiated Interview (BNI) compared to Narrative Interview and Standards of Care in reducing readmissions among patients with Substance Use Disorder (SUD) in the Alcoholic Detoxification Unit of Santa Rosita Psychiatric Specialties Hospital in 2024. Employing a randomized clinical trial design, the study aims to address a critical gap in understanding the optimal intervention for this vulnerable population.
Study Design: This trial adopts a prospective, randomized, three-arm design, with participants randomly assigned to one of three groups: BNI, Narrative Interview, or Standard Care. The randomization process utilizes a computer-generated list, ensuring an allocation ratio of 1:1:1. The trial encompasses a recruitment period of three months, followed by a three-month follow-up period.
Participants: The target population comprises 150 male patients aged 18 or older admitted to the Alcoholic Detoxification Unit during January 2024.
Interventions:
Brief Negotiated Interview (BNI): Modeled after motivational interviewing techniques, BNI aims to empower patients to explore reasons for change. Administered as a single 30-minute session, BNI encourages patient autonomy in decision-making regarding behavioral changes related to substance use.
Narrative Interview: A 20-minute session applying narrative therapy techniques, encouraging patients to explore and reframe their stories concerning substance use. The session emphasizes externalizing issues and examining social and political factors contributing to the problem.
Standard Care: Following the Alcohol Detoxification Management Protocol, standard care includes pharmacological interventions (benzodiazepines, thiamine, etc.), psychological evaluation on the third day, psychoeducational sessions, and psychiatric assessment for dual diagnoses.
Outcomes: Primary outcomes involve measuring rehospitalization rates at three months, time to relapse, reduction in substance consumption, and changes in depressive and anxious symptoms.
Statistical Analysis:Descriptive statistics will characterize nominal and categorical variables. For continuous variables, means and standard deviations will be calculated. Chi-square tests will assess the relationship between rehospitalization and intervention groups. Risk ratios and incidence rates will be computed to determine the relative risk of readmission.
Ethical Considerations: The study adheres to CONSORT guidelines, receiving approval from the Institutional Review Board. Informed consent is obtained from all participants, ensuring comprehension of the study's purpose, risks, and benefits. Confidentiality is maintained, and participants are informed of their right to withdraw without interference in their clinical care.
Conclusion: This comprehensive research design integrates rigorous methodology, ethical considerations, and a tailored intervention approach to address the multifaceted challenges faced by patients with SUD. The outcomes are expected to contribute valuable insights to the field, guiding evidence-based practices for enhanced patient outcomes and reduced readmission rates
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Negotiated Interview | Experimental | Other: Brief Negotiated InterviewThe BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. Instead of telling the patient what changes he/she should make, the BNI is intentionally designed to elicit reasons for change and action steps from the patient. It gives the patient voice and choice, making any potential behavior changes all the more empowering to the patient. |
| Narrative Interview | Placebo comparator | Other: Narrative InterviewThe Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions. |
| Standards of Care | No intervention | –This arm includes the use of benzodiazepines (Diazepam or Lorazepam) when CIWA-Ar scale is ≥9. Other medications may include Thiamine, Potassium Chloride, oral rehydration salts, parenteral fluids, antiemetics, and gastric protectants if medically necessary. Patients undergo a psychological evaluation on the third day of admission. All patients receive at least one psychoeducational session on alcohol and substance use during their hospitalization. Psychiatric evaluation is available for those with dual diagnoses such as mood disorders, anxiety disorders, psychotic disorders, or multiple substance use. The total hospitalization time in the ward is 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 18 or older who are hospitalized in the Alcohol Detoxification Unit during the period of January to March of 2024
- Patients with a score on the AUDIT scale greater than 15.
- Patients with a score equal to or greater than 4 for any substance on the World Health Organization-ASSIST.
- Patients from the Alcohol Detoxification Unit who provide their consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients with a score on the AUDIT scale less than 15.
- Patients with a score on the WHO-ASSIST scale for substances less than 4.
- Patients from the Alcohol Detoxification Unit who do not provide their consent to participate in the study.
- Patients from the Alcohol Detoxification Unit diagnosed with Delirium Tremens, Acute Intoxication of any substance, or conditions that alter consciousness.
- Patients from the Alcohol Detoxification Unit diagnosed with intellectual disability documented in the medical records.
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 Negotiated InterviewThe BNI is a specialized "brief intervention" for the medical setting, has foundations in motivational interviewing techniques. The BNI helps health care providers explore health behavior change with patients in a respectful, non-judgmental way within a finite time period. The BNI is in the form of an algorithm, or "script", that guides providers through the health intervention with carefully phrased key questions and responses, all at the providers' fingertips | Other | Brief Negotiated Interview |
| Narrative InterviewThe Narrative Interview is a therapeutic approach that aims to motivate the individual's conscious and transformative knowledge, skills, and capabilities. This interview is based on the technical components of narrative therapy, where the patient narrates their story, using externalizing language and considering social and political aspects related to the issue. It will focus on exploring past and present feelings, thoughts, and actions. | Other | Narrative Interview |
Primary outcome
Hospital Readmission Rate
Time frame: 3 months
Measurement of the readmissions rate at 3 months from the study's initiation. This could be a key indicator to assess the impact of interventions on relapse prevention.
Risk Rate of Readmission
Time frame: 3 months
Measurement of the risk rate through the ratio of the readmission rate treatment group and the control group rate
1 secondary outcome
HADS Score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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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.
Carlos M. Rosales, MD principal investigator
Universidad Nacional Autonoma de Honduras
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 Negotiated Interview and Narrative Interview in people with Substance Use Disorders and Substance Withdrawal, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
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 6 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 24 May 2024. 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 Honduras. 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. Some participants in this study may receive a placebo. 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?
Hospital Readmission Rate (time frame: 3 months). The study lists 2 primary outcomes in all. 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 24 May 2024.