What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes that align with the Positive-Psychology-Motivational Interviewing (PP-MI) approach include lifestyle modifications such as diet and exercise, and behavioral interventions. The side effects of lifestyle modifications are generally minimal but can include muscle soreness or injury from increased physical activity. Behavioral interventions, like motivational interviewing, typically have no physical side effects but may cause emotional discomfort as patients confront and change long-standing habits. Pharmacologic therapies, which may be used in conjunction with these approaches, can have side effects such as gastrointestinal issues (e.g., metformin), hypoglycemia (e.g., sulfonylureas), and weight gain (e.g., insulin).

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for Type 2 Diabetes, including metformin, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. While these medications primarily focus on glycemic control, behavioral interventions like Positive-Psychology-Motivational Interviewing (PP-MI) aim to enhance motivation and positive thinking to improve physical activity and diabetes management. Although specific FDA approvals for PP-MI are not mentioned, the combination of behavioral support and pharmacotherapy is recommended for optimal diabetes management.

What other types of research exist?

Promising alternatives to PP-MI for Type 2 Diabetes patients include: 1) Digital health interventions, such as smartphone applications and telehealth services, which provide personalized feedback and support for diabetes management. 2) Group-based motivational interviewing, which leverages peer support and shared experiences to enhance motivation. 3) Integrative approaches combining motivational interviewing with cognitive-behavioral therapy (CBT) to address both behavioral and psychological aspects of diabetes management. 4) Nurse-led interventions that focus on self-care education and regular follow-ups to ensure adherence and provide continuous support.

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Positive Psychology for Type 2 Diabetes (BEHOLD Trial)

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Diagnosis of Type 2 Diabetes

Be older than 18 years old

Must not have

Cognitive deficits impeding a participant's ability to provide informed consent or participate

Pre-existing coronary artery disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

Awards & highlights

Summary

This trial tests a program that combines positive thinking exercises, motivational talks, and supportive text messages to help adults with type 2 diabetes become more active. The goal is to improve their mood, motivation, and physical activity levels.

Who is the study for?

This trial is for individuals with Type 2 Diabetes who are not very active (less than 150 minutes of exercise per week). It's not suitable for those with severe heart disease, life-threatening conditions, cognitive issues preventing informed consent, major depression, or language barriers. Participants must be able to receive texts and not be in another well-being program.

What is being tested?

The study tests an 8-week positive psychology and motivational interviewing intervention via remote delivery plus text messages over a total of 16 weeks. This approach is compared against motivational interviewing alone in people with low physical activity levels.

What are the potential side effects?

Since the interventions involve psychological support and communication rather than medication, typical medical side effects are not expected. However, participants may experience emotional discomfort or stress during the process.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and make decisions about my health care.

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I have been diagnosed with coronary artery disease.

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I use insulin that is not long-acting.

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I cannot be physically active due to another health issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks 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 from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks

Secondary study objectives

Change from Baseline Overall Activity at 16 weeks

Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks

Other study objectives

Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks

Change from Baseline Overall Activity at 8, 24, and 52 weeks

Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 52 weeks

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive Psychology + Motivational InterviewingExperimental Treatment1 Intervention

Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).

Group II: Motivational InterviewingActive Control1 Intervention

Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive Psychology + Motivational Interviewing

2017

N/A

~200

0 / 5Eligibility 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

The most common treatments for Type 2 Diabetes include pharmacologic approaches like metformin, which reduces liver glucose production and enhances insulin sensitivity, and insulin therapy, which supplements insulin levels. Non-pharmacologic treatments focus on lifestyle changes, such as diet and exercise, to improve blood sugar control. The Positive-Psychology-Motivational Interviewing (PP-MI) approach aims to enhance motivation and positive thinking, helping patients overcome psychological barriers to increase physical activity and better manage their diabetes. This combination of medical and behavioral strategies is crucial for achieving optimal glycemic control and minimizing complications in Type 2 Diabetes patients.

Multicomponent approaches to promoting healthy behaviours in people with Type 2 diabetes: an integrative review.Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial.