What side effects are associated with this type of intervention?

Motivational Interviewing (MI) and similar psychosocial treatments like Cognitive Behavioral Therapy (CBT) and mindfulness-based interventions generally do not have physical side effects. However, they can sometimes lead to emotional discomfort as individuals confront and discuss challenging issues. Patients may experience increased anxiety, stress, or emotional distress during the initial stages of therapy. Additionally, there can be a risk of frustration or demotivation if progress is slower than expected. It is important for therapists to provide support and manage these emotional responses effectively.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments that are often used in conjunction with behavioral interventions like Motivational Interviewing to enhance self-efficacy. For smoking cessation, medications such as varenicline and nicotine replacement therapies (patches, gums, lozenges) are commonly used alongside behavioral support. In the treatment of substance use disorders, medications like buprenorphine, methadone, and naltrexone are approved and often paired with behavioral therapies to improve outcomes. These combined approaches aim to enhance patients' motivation and commitment to behavior change, similar to the goals of Motivational Interviewing.

What other types of research exist?

Promising alternatives to Motivational Interviewing for enhancing self-efficacy in patients include: 1) Cognitive Behavioral Therapy (CBT), which helps modify biased cognitions and behaviors; 2) Technology-enhanced CBT, such as web-based or app-based interventions; 3) Community Reinforcement Approach, which incorporates CBT principles with a focus on improving life satisfaction; 4) Behavioral Couples Therapy, which addresses problematic behaviors within relationships; and 5) Digital interventions like interactive web-based programs and mobile apps that provide personalized feedback and support.

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Motivational Interviewing for STI Prevention (TAKE Steps Trial)

N/A

Waitlist Available

Led By Sarah M Wood, MD, MSHP

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females aged 13 to 19 years

Confirmed treatment for a laboratory confirmed diagnosis of Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, Treponema pallidum within the prior 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests motivational interviewing sessions for adolescents with STIs. The sessions aim to educate them on preventing HIV/STIs, help them set health goals, teach new skills, and refer them to additional prevention methods. The goal is to support these adolescents in making healthier choices.

Who is the study for?

This trial is for English-speaking males and females aged 13 to 19 who have had at least one STI in the past month, treated for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or Treponema pallidum. They must be HIV negative and able to give informed consent without being intoxicated or in severe psychological distress.

What is being tested?

The TAKE Steps study tests a motivational interviewing intervention against standard care for teens with STIs. It aims to educate on HIV/STI prevention, set goals using motivational interviewing techniques, build skills, and refer participants to prevention strategies like PrEP and condom use.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal topics during interviews.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 13 and 19 years old.

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I have been treated for an STD within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, one month, three months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, one month, three months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, one month, three months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in prevention self-efficacy

Secondary study objectives

Intervention Acceptability

Recruitment Feasibility

Retention feasibility

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: T.A.K.E. Steps Motivational Interviewing InterventionExperimental Treatment1 Intervention

Four MI intervention sessions, 1:1 with participant and health coach.

Group II: Standard of CareActive Control1 Intervention

Standard of Care control visit with primary care physician (PCP)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treat Act Know Engage (T.A.K.E.) Steps

2022

N/A

~120

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for enhancing self-efficacy, such as motivational interviewing (MI), work by increasing a patient's motivation and commitment to behavior change through goal setting and skill building. MI is a client-centered approach that helps patients resolve ambivalence and build intrinsic motivation. This is crucial for self-efficacy patients as it empowers them to take control of their treatment, fostering confidence and a sense of agency. Other effective treatments include cognitive-behavioral therapy (CBT), which modifies negative thought patterns and behaviors, and contingency management, which uses positive reinforcement to encourage desired behaviors. These treatments collectively help patients develop the skills and confidence needed to manage their conditions and improve their overall quality of life.

A treatment strategy for meeting life as it is. Patients' and therapists' experiences of brief therapy in a district psychiatric centre: A qualitative study.