Mind and Motion for Type 2 Diabetes and Depression

(MenDIII Trial)

Overseen By Hannah Burgess, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Stage 2 hypertension, recent cardiac events, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 18 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants who are only receiving medication management for depression from a psychiatrist are allowed to join the study.

Is Mindfulness-Based Cognitive Therapy (MBCT) safe for humans?

Research suggests that Mindfulness-Based Cognitive Therapy (MBCT) is generally safe for humans, as it is a group-based intervention used for various mental health conditions, including depression and anxiety, without significant safety concerns reported. ^{1 2 3 4 5}

How is the Mind and Motion treatment for type 2 diabetes and depression different from other treatments?

The Mind and Motion treatment is unique because it combines cognitive behavioral therapy (CBT) with mindfulness-based approaches, which focus on improving mental health through techniques like mindfulness and acceptance. This approach not only addresses depression but also helps with stress and anxiety, making it a comprehensive mental health intervention for people with type 2 diabetes. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for Type 2 Diabetes and Depression?

Research shows that Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavior Therapy (CBT) are effective in reducing depressive symptoms in patients with diabetes, suggesting potential benefits for those with both Type 2 Diabetes and Depression. ^{1 11 12 13 14}

Who Is on the Research Team?

Jaclynn Hawkins, PhD

Principal Investigator

University of Michigan, School of Social Work

Are You a Good Fit for This Trial?

The MenD 3 trial is for Black men over 18 with type 2 diabetes and depression living in Wayne or Washtenaw County. They must have been diagnosed with diabetes for at least a year, have an A1C of 7.0%+, be under a doctor's care, willing to attend study events, and have reliable internet and transportation.

Inclusion Criteria

I am willing to attend weekly activities and health assessments for the study.

Patient Health Questionnaire-9 (PHQ-9) total score >=5 with no self-reported psychotic symptoms

My A1C level has been 7.0% or higher in the past year and I am under a doctor's care for diabetes.

Exclusion Criteria

I have an ongoing heart infection.

I have severe symptoms from a narrowed heart valve.

I have an acute aortic dissection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 sessions of cognitive behavioral therapy and, if in the intervention group, 8 sessions of guided exercise and 8 group discussion sessions

18 weeks

All sessions held via Zoom

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Health assessments at 10 weeks, 18 weeks, and 30 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy
• Exercise
• Group Discussions - Ongoing Support

Trial Overview This trial tests the effects of Cognitive Behavioral Therapy (CBT), guided exercise, and group discussions on managing type 2 diabetes and depression. Participants will engage in weekly activities via Zoom including CBT sessions, exercises, group support talks, plus health assessments at four intervals.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 3 Interventions

Participants randomized to the intervention group will receive 8 one hour virtual sessions of individual cognitive behavioral therapy (CBT) that will take place via U-M Zoom, which is a HIPAA compliant virtual conferencing platform. Participants in this group will also receive 8 one hour virtual sessions of individual exercise. Participants in this group will also receive 8 one hour virtual group discussion sessions that will serve as on-going support. This group (4-8 participants) discussion will be facilitated by one CBT Interventionist and one Exercise Interventionist. These sessions will take place following the individual sessions of CBT and Exercise.

Group II: Control Group Active Control 1 Intervention

Participants randomized to the control group will receive enhanced usual care (EUC). The EUC group will receive 8 sessions of standard Cognitive Behavioral Therapy.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

In a study involving 106 patients with chronic depression, the cognitive behavioral analysis system of psychotherapy (CBASP) was found to be significantly more effective than treatment-as-usual (TAU) in reducing depressive symptoms, indicating its potential as a strong treatment option.

Mindfulness-based cognitive therapy (MBCT) showed mixed results, being no more effective than TAU overall, but it did demonstrate some effectiveness at one treatment site, suggesting that its efficacy may vary based on specific contexts or populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. Michalak, J., Schultze, M., Heidenreich, T., et al.[2018]

In a study of 91 adults with diabetes and depressive symptoms, both Cognitive Behavior Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) were found to be effective in reducing depressive symptoms over an 8-week treatment period.

Higher educational attainment was associated with a better immediate response to MBCT compared to CBT, but this difference did not persist at the 9-month follow-up, suggesting that both therapies are generally effective across diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What works best for whom? Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy for depressive symptoms in patients with diabetes. Tovote, KA., Schroevers, MJ., Snippe, E., et al.[2018]

Mindfulness-based cognitive therapy (MBCT) shows lasting benefits for chronically treatment-resistant depressed patients, with improvements in depressive symptoms, quality of life, and self-compassion persisting for up to 6 months after treatment, based on a study of 106 participants.

Higher baseline levels of rumination were linked to lower depressive symptoms and better quality of life at the 6-month follow-up, suggesting that individuals with more rumination may benefit more from MBCT, although further research is needed to confirm this finding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up outcomes of Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic, treatment-resistant depression. Cladder-Micus, MB., Vrijsen, JN., Fest, A., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) provided sustained reductions in perceived stress, anxiety, and depressive symptoms for up to six months in 139 outpatients with diabetes, demonstrating its effectiveness in improving emotional well-being.

However, MBCT did not significantly impact diabetes distress or glycemic control (HbA1c), indicating that while it helps with emotional issues, it may not directly address diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial. van Son, J., Nyklíček, I., Pop, VJ., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness-based cognitive therapy (MBCT) is as effective as maintenance antidepressant medication in preventing relapse in patients with major depressive disorder who have achieved remission, based on a study of 160 patients followed for 18 months.

For patients with unstable remission, both MBCT and maintenance treatment significantly reduced the risk of relapse by 73% compared to placebo, emphasizing the need for ongoing treatment in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Segal, ZV., Bieling, P., Young, T., et al.[2021]

Mindfulness-based cognitive therapy (MBCT) is effective for preventing relapse in recurrent depression, showing efficacy comparable to maintenance antidepressants, based on several randomized controlled trials.

Preliminary studies suggest that MBCT may also be beneficial for treating active depression, including treatment-resistant cases, as well as in bipolar disorder and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. Sipe, WE., Eisendrath, SJ.[2018]

Cognitive-behavioral therapy (CBT) is based on scientific experimentation rather than just theories, making it a unique and evidence-based approach to treatment.

Recent research at the University of Minnesota has integrated new neuroscientific findings with CBT, potentially enhancing its effectiveness and understanding in therapeutic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. Kushner, MG.[2018]

Mind-body training, including mindfulness and yoga, has been shown to significantly reduce anxiety, depression, and stress levels in adults with type 2 diabetes mellitus (T2DM), based on a systematic review of eight randomized controlled trials.

The interventions varied in duration from 8 weeks to 6 months, with four studies showing significant improvements in anxiety and six demonstrating effectiveness in treating depression, highlighting the importance of integrating mental health care into diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. Ruiz-Ariza, B., Hita-Contreras, F., Rodríguez-López, C., et al.[2023]

Acceptance and Commitment Therapy (ACT) significantly reduced glycated hemoglobin levels in people with type 2 diabetes, indicating improved blood sugar control, based on a meta-analysis of three trials.

ACT also enhanced self-care abilities related to diabetes management, as evidenced by a higher score on the summary of diabetes self-care activities, suggesting it can be an effective psychological intervention for diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of acceptance and commitment therapy for people with type 2 diabetes: Systematic review and meta-analysis. Sakamoto, R., Ohtake, Y., Kataoka, Y., et al.[2022]

In a study of 94 adults with diabetes and depressive symptoms, both mindfulness-based cognitive therapy (MBCT) and cognitive behavior therapy (CBT) significantly reduced depressive symptoms compared to a waiting-list control, with effect sizes indicating clinically relevant improvements of 26% and 29%, respectively.

Both MBCT and CBT also positively impacted anxiety, well-being, and diabetes-related distress, demonstrating their efficacy in addressing psychological symptoms in individuals with type 1 and type 2 diabetes, although they did not significantly affect HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual mindfulness-based cognitive therapy and cognitive behavior therapy for treating depressive symptoms in patients with diabetes: results of a randomized controlled trial. Tovote, KA., Fleer, J., Snippe, E., et al.[2022]

Cognitive Behaviour Therapy (CBT) interventions can improve self-management practices in individuals with type 2 diabetes, as highlighted by a rapid review of nine studies, primarily from developing countries.

The review emphasizes the importance of tailoring CBT interventions to the socio-economic contexts of individuals, particularly in South Africa, to enhance their effectiveness in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. Visagie, E., Deacon, E., Kok, R.[2023]

Cognitive behavior therapy (CBT) significantly reduces depression symptoms and improves quality of life in diabetic patients with comorbid depression, based on a meta-analysis of 10 randomized controlled trials involving 998 participants.

CBT also leads to long-term improvements in fasting glucose levels and anxiety, although it does not show significant effects on glycemic control or diabetes-related distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for patients with diabetes and depression. Li, C., Xu, D., Hu, M., et al.[2018]

Citations

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

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

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

A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. [2018]

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

What works best for whom? Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy for depressive symptoms in patients with diabetes. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Follow-up outcomes of Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic, treatment-resistant depression. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

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

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. [2021]

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

Mindfulness-based cognitive therapy: theory and practice. [2018]

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

The use of cognitive-behavioral therapy in the University of Minnesota's outpatient psychiatry clinic. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Mind-Body Training as a Mental Health Therapy in Adults with Diabetes Mellitus Type II: A Systematic Review. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of acceptance and commitment therapy for people with type 2 diabetes: Systematic review and meta-analysis. [2022]

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

Individual mindfulness-based cognitive therapy and cognitive behavior therapy for treating depressive symptoms in patients with diabetes: results of a randomized controlled trial. [2022]

13. South Africa pubmed.ncbi.nlm.nih.gov

Exploring the role of CBT in the self-management of type 2 diabetes: A rapid review. [2023]

14. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for patients with diabetes and depression. [2018]