Positive Psychology for Type 2 Diabetes

(BEHOLD Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Must not be taking: Non-basal insulin

Disqualifiers: Cognitive deficits, Coronary artery disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Positive Psychology-Motivational Interviewing Intervention (PP-MI) for Type 2 Diabetes?

Research shows that Motivational Interviewing (MI) can help improve blood sugar control in people with type 2 diabetes. Additionally, combining Positive Psychology (PP) with MI has been found to encourage physical activity, which is beneficial for managing diabetes. ^{1 2 3 4 5}

Is the Positive Psychology-Motivational Interviewing intervention safe for humans?

The studies on Positive Psychology-Motivational Interviewing (PP-MI) interventions, including Motivational Interviewing (MI), have not reported any safety concerns, suggesting that these approaches are generally safe for humans. ^{1 4 5 6 7}

How is the Positive Psychology-Motivational Interviewing treatment different from other treatments for type 2 diabetes?

This treatment is unique because it combines positive psychology, which boosts optimism and well-being, with motivational interviewing, a technique that encourages behavior change, to specifically promote physical activity in people with type 2 diabetes. Unlike traditional treatments that focus on medication or diet alone, this approach aims to improve health behaviors by enhancing positive emotions and motivation. ^{1 2 5 6 7}

Research Team

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Motivational Interviewing (Behavioral Intervention)
• Positive Psychology + Motivational Interviewing (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

The Effectiveness of Motivational Interviewing on Glycemic Control for Adults with Type 2 Diabetes Mellitus (DM2): A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Positive Psychological Interventions for Patients with Type 2 Diabetes: Rationale, Theoretical Model, and Intervention Development. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Training diabetes healthcare practitioners in motivational interviewing: a systematic review. [2022]

4. United States 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. [2021]

5. United States 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. [2022]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A positive psychology-motivational interviewing intervention for patients with type 2 diabetes: Proof-of-concept trial. [2020]