Positive Psychology for Type 2 Diabetes

(BEHOLD Trial)

Overseen By Jeff C Huffman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Non-basal insulin

Disqualifiers: Cognitive deficits, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining positive psychology with motivational interviewing (a type of therapy) can enhance physical activity and well-being in people with type 2 diabetes. Participants will engage in either motivational interviewing alone or a combination of positive psychology and motivational interviewing. The trial includes weekly activities, phone sessions, and text message support. It suits those diagnosed with type 2 diabetes who are not very active (less than 150 minutes of moderate to vigorous exercise per week) and can receive text messages. As an unphased trial, this study offers a unique opportunity to explore innovative approaches to improve well-being and physical activity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using non-basal insulin, you would not be eligible to participate.

What prior data suggests that this intervention is safe for individuals with type 2 diabetes?

Research has shown that Motivational Interviewing (MI) is safe and well-received by people with type 2 diabetes. Studies have found that MI effectively encourages positive behavior changes without serious side effects. Patients typically respond well to it, gaining a better understanding of and ability to manage their diabetes.

When combined with Positive Psychology (PP), early research suggests this approach remains safe. This combination aims to increase positive feelings and physical activity in people with type 2 diabetes. Although the behavior changes are modest, studies have not reported any harm or significant negative effects.

Overall, both MI alone and the PP-MI combination appear to be safe ways to help manage diabetes without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique combination of motivational interviewing (MI) and positive psychology (PP) to manage Type 2 Diabetes. Unlike standard treatments that focus mainly on medication and lifestyle changes, this approach emphasizes mental and emotional support to improve adherence to health behaviors. The PP-MI method incorporates weekly activities that boost mental well-being and set achievable physical activity goals, potentially enhancing motivation and overall health outcomes. By integrating these psychological strategies, the trial aims to discover if a more holistic approach could offer better support for managing Type 2 Diabetes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Studies have shown that motivational interviewing (MI), which participants in this trial may receive, can significantly help people with type 2 diabetes manage their condition, boost their confidence, enhance their quality of life, and control blood sugar levels. Research also suggests that adding positive psychology (PP) to MI, another treatment option in this trial, might further increase physical activity and overall well-being. In previous trials, participants found the combined PP-MI approach easy to follow and beneficial. This approach addresses both mental and physical health, aiming to improve lifestyle choices and diabetes management. Early signs are promising, indicating that PP-MI could be a valuable tool for those with type 2 diabetes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

You don't exercise much, less than 2.5 hours of moderate to vigorous activity per week.

Exclusion Criteria

You have a score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9), indicating moderate to severe depression.

Inability to receive text messages

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants provide informed consent, complete baseline outcome measures, and wear an accelerometer for one week to monitor physical activity

1 week

1 visit (in-person)

Treatment

Participants receive an 8-week intervention with weekly phone sessions and twice weekly text messages

8 weeks

8 phone sessions

Initial Follow-up

Participants receive twice weekly text messages for an additional 8 weeks, with interactive messages for the PP-MI group

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 8, 16, 24, and 52 weeks

44 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing
• Positive Psychology + Motivational Interviewing

Trial Overview 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.

How Is the Trial Designed?

Group I: Positive Psychology + Motivational Interviewing Experimental Treatment 1 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 Interviewing Active Control 1 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).

Motivational Interviewing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Motivational Interviewing for:

• Substance Use Disorders
• Mental Health Conditions

Approved in European Union as Motivational Interviewing for:

• Addiction Treatment
• Behavioral Health Interventions

Approved in Canada as Motivational Interviewing for:

• Substance Abuse Treatment
• Mental Health Counseling

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The novel combined positive psychology-motivational interviewing (PP-MI) intervention was highly feasible and well-accepted among participants with type 2 diabetes, with 92% of sessions completed and high ease/utility ratings (8.5 to 8.8 out of 10).

Participants in the PP-MI group showed significant improvements in both positive affect and moderate to vigorous physical activity (MVPA), with a notable increase of 13.05 minutes per day in MVPA at 8 weeks, indicating the intervention's potential effectiveness in promoting physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial. Huffman, JC., Golden, J., Massey, CN., et al.[2022]

Motivational interviewing (MI) and its adaptations (AMIs) are effective strategies for promoting behavior change in adults with type 2 diabetes, potentially leading to improved glycemic control and better health outcomes.

Despite the positive impact of MI on behavior change, the review found no significant isolated effects on lowering glycosylated hemoglobin (HbA1c) levels, indicating that while MI can empower patients, its direct impact on clinical measures like HbA1c needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Motivational Interviewing on Glycemic Control for Adults with Type 2 Diabetes Mellitus (DM2): A Systematic Review. Concert, CM., Burke, RE., Eusebio, AM., et al.[2022]

The study found that motivational interviewing (MI) did not significantly improve metabolic status or medication adherence in patients with type 2 diabetes compared to standard treatment, despite both groups showing improved metabolic status after one year.

Both treatment groups achieved excellent medication adherence, suggesting that the training in target-driven intensive treatment may have been effective on its own, and that GPs in the control group may have incorporated elements of MI into their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of "motivational interviewing" on quality of care measures in screen detected type 2 diabetes patients: a one-year follow-up of an RCT, ADDITION Denmark. Rubak, S., Sandbæk, A., Lauritzen, T., et al.[2021]

Positive psychology (PP) interventions, which aim to enhance optimism and well-being, have not been previously tested in patients with type 2 diabetes (T2D), despite their potential to improve health behaviors.

A proof-of-concept study involving 15 T2D patients suggests that PP interventions could be a simple and effective way to boost adherence to diet, exercise, and medication, especially when combined with motivational interviewing techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Psychological Interventions for Patients with Type 2 Diabetes: Rationale, Theoretical Model, and Intervention Development. Huffman, JC., DuBois, CM., Millstein, RA., et al.[2022]

A 16-week phone-delivered positive psychology-motivational interviewing (PP-MI) program was feasible and well-accepted among 70 participants with type 2 diabetes, achieving a high session completion rate of 79% and a mean utility rating of 8.6 out of 10.

Participants in the PP-MI program showed small to medium improvements in physical activity levels, with a notable increase in moderate to vigorous physical activity and daily steps, indicating potential benefits for enhancing physical activity in individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A positive psychology-motivational interviewing program to promote physical activity in type 2 diabetes: The BEHOLD-16 pilot randomized trial. Huffman, JC., Golden, J., Massey, CN., et al.[2023]

A systematic review of 17 studies involving diabetes healthcare practitioners found that training in Motivational Interviewing (MI) consistently improved practitioners' MI skills, with 14 studies showing over 50% improvement.

To effectively maintain and enhance MI skills, training programs should incorporate education, role play, and ongoing supervision, as the effectiveness of MI application varied among practitioners post-training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training diabetes healthcare practitioners in motivational interviewing: a systematic review. Kaczmarek, T., Kavanagh, DJ., Lazzarini, PA., et al.[2022]

A novel 16-week telephone-delivered intervention combining positive psychology and motivational interviewing showed high feasibility, with 78% of activities completed and high ratings for ease and usefulness among participants with type 2 diabetes.

The intervention led to improved adherence to health behaviors and modest improvements in body mass index and hemoglobin A1c (A1C), suggesting potential benefits for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A positive psychology-motivational interviewing intervention for patients with type 2 diabetes: Proof-of-concept trial. Celano, CM., Gianangelo, TA., Millstein, RA., et al.[2020]

Citations

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Effects of motivational interviewing intervention on self ... The motivational interview did improve participants significantly in self-management, self-efficacy, quality of life, and HbA1c among diabetes people.

2. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/full/10.1111/wvn.70041

Effectiveness of Transtheoretical Model‐Based Motivational ... “Motivational Interviewing and Outcomes in Adults With Type 2 Diabetes: A Systematic Review.” Patient Education and Counseling 99, no. 6 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8719550/

Comparing the effectiveness of motivational interviewing ... The aim of this study was to compare the effectiveness of motivational interviewing with self-development education on T2D patients' lifestyle.

4. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-019-4776-8

Effectiveness of motivational interviewing on improving Care ... The PEP has a significant effect on improving diabetes-related distress, but MI was not significantly different from the traditional health education programs.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04120844

Effectiveness of Motivational Interviewing on Improving ... Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3686502/

How Patients with Type 2 Diabetes Mellitus Respond to ... To determine how patients with Type 2 DM feel about a Motivational Interviewing (MI) intervention designed to promote positive behavior change.

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Motivational Interviewing: An Evidence-Based Approach for ... Meta-analyses reveal statistically significant mean intervention effects of MI in medical care with respect to a variety of health-relevant modes of behavior, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0033062023000099

Using motivational interviewing and brief action planning ... We review two approaches that incorporate evidenced-based skills for this purpose: motivational interviewing and brief action planning (BAP).

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Study Details | NCT06374186 | Continuous Glucose ... This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.

10. tandfonline.com tandfonline.com/doi/full/10.1080/02813430903072876

General practitioners trained in motivational interviewing ... This study reports a significant effect of MI on patients' understanding of diabetes, of beliefs regarding treatment aspects, and of their motivation for ...