The Use of Brief Motivational Interviewing in Community Health Centers. (BMICHC)

The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status

The research project aims to detect the effect of the Brief Motivational Interview (BMI) on the motivation to change risky behaviors and the adoption of healthy lifestyles by citizens attending Community Health Centers (CdC). The controlled, multicenter, prospective design study involves the enrollment of 304 people, with 152 at the Borgo Reno CdC and 152 at the Navile CdC.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Behavioral: Brief Motivational Interviewing; Behavioral: Standard of Care (SOC)

Detailed Description

The study will include 152 citizens who use the services of the Borgo Reno Community Health Center and 152 citizens from the Navile Community Health Center. Eligible participants will be identified with the help of specialist medical staff and nursing staff at the facility. Once an eligible participant is identified, the Brief Motivational Interview (BMI) can be conducted during regular institutional activities (if the operator on duty at that time is trained to conduct the BMI and after obtaining informed consent and completing the SF-36 questionnaire) or by scheduling an appointment with the nursing and/or facility staff for a dedicated BMI clinic.

Students from the degree courses in "Psychology," "Human Nutrition, Wellness, and Health," and "Wellness, Sport, and Health," who are appropriately trained and authorized, will contribute to the research study by providing all necessary information. Participants in the experimental group who are given an appointment will sign the informed consent for participation and consent for the processing of personal and sensitive data. They will also receive a letter for their general practitioner explaining the study procedures. Inclusion and exclusion criteria will be assessed. If the criteria are met, the citizen will be included in the study.

Citizens enrolled at the Borgo Reno Community Health Center will be assigned to the experimental group (with intervention), while those enrolled at the Navile Community Health Center will be part of the control group (without intervention). A clinic will be dedicated to this study, where professionals (specialist/home nursing staff, dietitians, physiotherapists, IFeC) from the Community Health Center who have received training from the CCM course on Brief Motivational Interviewing will conduct the sessions.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Pandolfi, Doctor; Phone Number: 0039516224423; Email: paolo.pandolfi@ausl.bologna.it
• Study Contact Backup: Name: Muriel Assunta Musti, Statistic; Phone Number: 003951286 9397; Email: murielassunta.musti@ausl.bologna.it

Study Locations

• Italy
  • IT
    • Bologna, IT, Italy, 40100
      • Recruiting
      • Dipartimento Sanità Pubblica
      • Contact: Paolo Pandolfi, Doctor; Phone Number: 0039516224423; Email: paolo.pandolfi@ausl.bologna.it
      • Contact: Paolo Pandolfi, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• first visit to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services or other medical specialties of the Borgo-Reno or Navile Community Home or referred to them.
• resident in the AUSL of Bologna
• age ≥18 years

Exclusion Criteria:

• second or more visits to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services, or other medical specialties of the Borgo-Reno or Navile Community House or referred to them.
• first visit to a service not indicated in the inclusion criteria
• not resident in the territory of the AUSL of Bologna
• age <18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community House Borgo Reno; The health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes	Behavioral: Brief Motivational Interviewing; Brief Motivational Interviewing (BMI), the object of the training and of the present research study, is an interview methodology that includes the intervention on the motivation to change of subjects with risky behaviors for their health, in order to obtain changes in their lifestyle and maintain correct behaviors for health over time (1). The BMI is mainly based on the Transtheoretical Model of Change by Di Clemente CC. and Prochaska JO (2). In particular, the BMI has been defined by its creators, Miller and Rollnick, as "a collaborative style of conversation aimed at strengthening motivation and commitment to change" (3), both through defined attitudes, strategies and techniques, and through the exploration of ambivalence or internal fracture, which together with availability and a sense of self-efficacy (4) provides a framework of personal motivation.
Active Comparator: Community House Navile; The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire Send feedback	Behavioral: Standard of Care (SOC); Standard of Care (SOC) - The health workers of the Navile Community House carry out the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	The 36-item Short Form Health Survey (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.	From enrollment to the end of treatment at 6 MONTHS

Collaborators and Investigators

• Sponsor: Azienda Usl di Bologna

Publications and helpful links

General Publications

• Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. doi: 10.1016/S0738-3991(03)00141-1.
• Ghizzardi G, Arrigoni C, Dellafiore F, Vellone E, Caruso R. Efficacy of motivational interviewing on enhancing self-care behaviors among patients with chronic heart failure: a systematic review and meta-analysis of randomized controlled trials. Heart Fail Rev. 2022 Jul;27(4):1029-1041. doi: 10.1007/s10741-021-10110-z. Epub 2021 Apr 17.
• Pedamallu H, Ehrhardt MJ, Maki J, Carcone AI, Hudson MM, Waters EA. Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. J Med Internet Res. 2022 Aug 9;24(8):e35283. doi: 10.2196/35283.
• Rogers CR. A theory of therapy, personality and interpersonal relationships as developed in the client-centered framework. In: Koch S. (ed). Psychology: a study of a science, vol. III. Formulations of the person in the social context. McGraw Hill, New York, 1959.
• Bandura A., Self-efficacy mechanism in human agency. American Psychologist, 1982; 37: 122-47
• Miller WR, Rollnick S. Motivational Interviewing. Helping people change. Guilford Press, New York, 1991.
• Prochaska JO. Di Clemente CC. Transtheorical therapy: toward a more integrative model of change. Psychotherapy, theory, research and practice 1982.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing
• Other Study ID Numbers: 24014 - 81-2024-SPER-AUSLBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No