Given the aforementioned evidence regarding the role of lifestyle in both glycemic status and depression, we hypothesized that, relative to social services, participants receiving lifestyle intervention would show improved depressive symptoms, HbA1c, and insulin resistance at post-intervention.

Further, given evidence regarding the role of psychoactive medication in both glycemic status and depression, we hypothesized that the combined arm lifestyle plus medication therapy management would show more improvement in these primary outcomes than the lifestyle-only arm.

In secondary analyses we examined effects on inflammation and stress hormones. Eat, Walk, Sleep EWS is a cardiometabolic lifestyle curriculum that was created through community based, participatory methods. It was created by and for Khmer people and is intended to be delivered by lay health workers We compared the efficacy of Eat, Walk, Sleep EWS vs.

Assessments were at baseline, post-treatment 12 months and follow-up 15 months. Study personnel who had contact with participants had been born in Cambodia and were bilingual and bicultural. To minimize bias, lay health workers were divided into two roles.

Community health educators CHEs delivered intervention sessions. Community health workers CHWs conducted all data collection.

Details of the lifestyle intervention and study protocol 19 have been described previously. The study was conducted according to the World Medical Association Declaration of Helsinki and approved by the UConn Health institutional review board.

Participants signed written informed consent forms in their preferred language Khmer or English , provided a release of information for study staff contact with their healthcare provider, and provided written HIPAA authorization. Participants were recruited through community and clinical settings.

Because this was a diabetes prevention intervention, individuals with extant diabetes were not eligible to participate. Inclusion criteria were: 1 aged 35—75; 2 Cambodian or Cambodian-American; 3 Khmer speaking; 4 currently living in Connecticut, Massachusetts, or Rhode Island; 5 lived in Cambodia during the Pol Pot regime — ; 6 ambulatory; 7 consumed meals by mouth; 8 elevated risk for diabetes per a modified version of the American Diabetes Association Risk Test Total risk score, rather than a single indicator such as HbA1c, was used for eligibility.

The scoring included east Asian cutoffs for waist circumference as a measure of adiposity rather than BMI. Exclusion criteria were: type 2 diabetes; seeing or hearing problems that would interfere with group sessions; major medical problems requiring intensive treatment; pregnancy or planning pregnancy; serious thinking or memory problems e.

In March recruitment began but by early it became apparent that the enrollment goal would not be met within the timeframe of the funding period.

Therefore, target sample size was reduced and the allocation ratio was changed to going forward in order to gather relatively more information on the two intervention groups. The plan was approved by the funder and all other aspects of randomization remained the same. CHW data collectors conducted assessments.

The CHWs administered surveys verbally and recorded responses in Remote Electronic Data Capture REDCap 21 using a tablet. They also collected hair samples for the assessment of cortisol.

Recruitment began in March and data collection ended in September After baseline assessments, participants were individually randomized by a monolingual English speaking research assistant at UConn Health who had no direct contact with participants using an urn randomization 22 computer program that balanced the three treatment arms on gender, age, symptoms of post-traumatic stress disorder, and site Connecticut, Rhode Island, Massachusetts.

The study coordinator also telephoned to notify the site-specific CHE interventionist of the allocation. The CHWs, who conducted all study assessments, worked in close proximity to the CHEs so it was not possible to blind CHWs to allocation. EWS is a trauma-informed, cardiometabolic education curriculum based on Buddhist concepts of health and disease that is designed for delivery by CHEs to low literacy, low numeracy learners 18 , Behavioral targets of EWS include eating no more than 1 small bowl of brown rice per meal, walking at least 30 min per day on 6 days per week, and getting 7—9 h of restful sleep per night Those targets are worked toward over time using session-to-session goal setting.

The EWS lifestyle curriculum was designed to meet or exceed the published guidelines for diabetes prevention interventions set forth in the National Institute for Health and Clinical Excellence NICE 25 and Implementation of A European Guideline IMAGE MTM followed guidelines of the American Pharmacists Association The CHE, participant, and pharmacist identified drug-therapy problems.

Problems were categorized as safety does the patient have, or is the patient at risk for, adverse drug reactions? This was not a drug trial.

Participants who received MTM received consultations with a pharmacist to resolve any medication problems, but no specific medications were tested as part of the protocol.

The four pharmacists were either nationally certified in MTM or board-certified in ambulatory care, geriatric, or psychiatric pharmacy. Participants who were assigned to SS were assessed for any social service needs such as food or housing assistance, referral to a healthcare provider, tax preparation, or citizenship applications.

CHWs were tasked with following up to meet any identified needs, and contacts were documented over the following 12 months. Demographics included self-reported sex, age, income, employment, education, health insurance status and type, years in the U.

Glycosylated hemoglobin A1c HbA1c was assayed at Quest laboratory using direct enzymatic assay. Hemoglobinopathies, which vary by population, can make some HbA1c assays unreliable. Hb E is the hemoglobinopathy of most concern to this study because it is not uncommon in Southeast Asians.

Therefore, we used a direct enzymatic assay because this method is unaffected analytically by Hb variants Cortisol in human hair is a putative biomarker of chronic stress. Hair samples were obtained from approximately 2 cm below the cranial bone. hsCRP is an inflammatory marker that is found to be high in the setting of insulin resistance and depression.

hsCRP was measured by Quest Laboratories using an immunoturbidimetric assay. For descriptive purposes only we also assessed lipids and anthropometrics over time. LDL was calculated using the Martin—Hopkins calculation Weight was measured using a calibrated electronic Seca Chino, California digital scale.

Waist circumference was measured at the umbilicus with an inelastic tape. Blood pressure was measured twice with calibrated digital sphygmomanometer Omron, Hoffman Estates, IL For all measurements, discrepant values of two trials exceeding a predetermined allowance triggered a third measurement and the two closest values were averaged.

Fixed effects included group, time point, and the interaction between group and time point. To account for the correlation in the outcome values across time points the covariance was modeled using AR 1 with heterogenous variance and also a random intercept that varied by patient.

All eligible participants were included in each analysis by original assigned groups. Alpha was set at 0. See Fig.

There were no significant differences among the three treatment groups in any of the baseline demographic or clinical characteristics Table 1.

They were on average 16 years old in at the end of the 4-year Pol Pot regime. Mean drug therapy problems per participant in the MTM arm at baseline was 6. Figure 2 A shows Hopkins depression score across time points by treatment group and the top of Table 2 presents the means.

Contrasts revealed the change from baseline to endpoint did not differ between groups, but the change between baseline and follow-up did. Figure 2 B shows the mean profile across time points by group of HbA1c and the top of Table 2 presents the means.

There were no significant differences between groups at 15 months. Figure 2 C shows the mean profile of the third primary outcome, insulin resistance natural log transformed HOMA and the top of Table 2 displays the means. The bottom of Table 2 displays the means for other biological variables for each treatment group by time point, along with the p-value from the tests comparing the two intervention groups versus the SS group on the change from baseline values.

There was no significant time point effects or group effects for BMI, LDL, HDL, cholesterol, triglyceride, or hsCRP. Whereas they were not among our primary or secondary outcomes, we found that waist circumference, SBP and DBP decreased at post-treatment and follow-up for all groups.

There were no significant changes in lipids. Our first main finding is that in this sample, the combination of lifestyle and MTM reduced HbA1c, but lifestyle alone did not. This is commensurate with a meta-analysis of 69 lifestyle interventions for diabetes prevention at 12 months Whereas the effects are similar in size, our findings are compelling given that our participants were taking anti-depressants or had elevated depression symptoms, they had high rates of trauma exposure and post-traumatic stress, very low educational attainment, and our interventionists were CHEs.

Also, whereas our participants had accumulated risk factors for diabetes, many had a normal baseline HbA1c, which created floor effects for some participants, making change in HbA1c harder to detect. Indeed, we had hoped that, upon receiving the recommendation from the pharmacist accompanied by a detailed laboratory report, providers would initiate metformin, but in no case did this occur.

Therefore, any effects of MTM were due to changes in other medications or to participant medication taking behaviors. We suspect that MTM mitigated drug interactions, optimized medication doses, and increased adherence.

MTM provides pharmacists the opportunity to make salutary modifications to various medications that might affect HbA1c. For example, at baseline one participant had extant drug therapy problems with seven drugs that are known to effect HbA1c albuterol [bronchodilator beta agonist], hydrochlorothiazide [thiazide diuretic], risperidone [atypical antipsychotic], trazadone [antidepressant], fluoxetine [serotonin-specific reuptake inhibitor], and fluticasone and dulera [both steroids].

It is important to remember that all participants met study criteria for depression at baseline. MTM provides the opportunity to resolve problems with psychiatric medications such as anti-depressants and third-generation antipsychotics that are associated with dysglycemia.

Antidepressants are associated with an elevated risk of diabetes, with pooled adjusted Hazard Ratios HRs from 1. In the DPP, baseline antidepressant use was associated with conversion to diabetes in the placebo HR 2. Among DPP participants who lost weight, those on antidepressants had higher risk of weight regain Pharmacists working with CHEs may be best positioned to make recommendations about balancing effective depression treatment with potential deleterious metabolic effects of antidepressant medications.

Another main finding, that there was no change in insulin resistance, suggests that any beneficial effects of MTM on HbA1c were not mediated by increased insulin sensitivity.

Whereas some medications may increase glycemia directly e. The third main finding is that both treatment groups lowered depressive symptoms relative to SS, even though EWS was not designed as a depression treatment.

EWS included scheduling, goal setting and increased socialization which are components of behavioral activation, a well validated depression treatment 37 that can be delivered by lay health workers. EWS also included physical activity sessions which can have direct mood enhancing effects The SS arm did see a reduction in depressive symptoms; we suspect that this reduction was due to non-specific intervention factors often seen in behavioral studies such as attention which creates the very rationale for an attention-control condition.

This demonstrates that the active interventions had a stronger depression treatment effect than the SS comparison group. Surprisingly, all groups showed decreased blood pressure and waist circumference over time.

Whereas the SS group did not receive either of our active interventions per se, they did receive on-demand social services from CHWs that could putatively affect health such as referrals for food assistance, healthcare providers, assistance processing insurance documents, and translation of written materials.

Alternatively, contamination may have contributed to the benefits observed in the SS group. That waist circumference but not BMI decreased over time for all groups may reflect that glycemia of east Asians, relative to other groups, is more sensitive to central adiposity.

It has been consistently observed that diabetes presents at a lower BMI in east Asians compared to whites.

These observations of decreased waist circumference and cortisol highlights that depression-related cortisol directs fat deposits viscerally Our high retention rate is also quite noteworthy.

We attribute this primarily to high level of skill of the community health educators who were carefully chosen, thoroughly trained, and regularly supervised. Participant satisfaction with the interventions was high Our culturally derived interventions were founded in culturally specific fundamentals about health, illness, symptoms, healers and cures.

Rather than translating the DPP in Khmer, we started with Cambodian concepts, ideals, and collective history to address metabolic risk. The flexibility of the protocol for intervention delivery rolling enrollment, makeup sessions also facilitated high level of participation and retention.

Several limitations should be acknowledged. First, our sample was relatively small so we may not have been powered to detect changes between groups in secondary outcomes like hair cortisol and c-reactive protein. Our duration of follow-up was only 3 months after post-treatment and 15 months after baseline so the longer-term durability of these effects are unknown.

We did not have a sample size sufficient to investigate specific medication changes in the MTM group that might have led to lowered HbA1c. Moreover, drug therapy problems and their resolution could pertain to any permutation of medications e.

A larger study with very granular data collection regarding MTM processes is necessary to understand what specific changes lead to a decrease in HbA1c.

What is clear, however, is that in this randomized trial, the MTM intervention decreased HbA1c. Because there is no objective measure of depressive symptoms, our assessment of depressive symptoms was per self-report which may be vulnerable to demand characteristics.

Our sample was geographically centered in New England where weather and neighborhood factors that affect lifestyle may not generalize to, say, southern California where the other large community of Cambodian Americans live. DREAM decreased biological HbA1c and behavioral depressive symptoms risk for type 2 diabetes, and did so in a challenging sample of non-English speaking, refugee participants.

Similar approaches may apply to other communities with historical trauma and barriers to appropriate care. Even with adequate healthcare coverage through insurance or government healthcare, many immigrant and refugee groups will continue to have barriers to linguistically and culturally appropriate care.

Incorporating our cross-cultural and interdisciplinary model that incorporates medication therapy management may be beneficial to other minority, immigrant and refugee groups and other groups with high rates of depression.

Knol, M. et al. Depression as a risk factor for the onset of type 2 diabetes mellitus A meta-analysis. Diabetologia 49 5 , — Article CAS PubMed Google Scholar. Mezuk, B. They found that only Obese people are significantly more likely to have type 2 than those of a healthy weight.

The researchers also noted seven genetic variants that contribute to both type 2 diabetes and depression. These shared genes play a role in insulin secretion or inflammation in the brain, pancreas or fat tissue, with changes in these biological processes potentially explaining how depression increases type 2, they suggested.

And while a direct cause was not found for diabetes causing depression, experts still believe that the burden of living with type 2 diabetes may be a factor in developing depression. News Opinion Sport Culture Lifestyle Show More Show More News View all News World news UK news Climate crisis Ukraine Environment Science Global development Football Tech Business Obituaries.

A nurse giving a patient a diabetes test. Researchers have found a causal relationship suggesting depression may be a cause of the condition. There is also a gap between the sexes. Females with diabetes are twice as likely as males with diabetes to be diagnosed with depression. Treating depression can help you better manage your diabetes.

Untreated depression can affect all areas of your life and make it more difficult for you to practice self-care, like getting enough exercise and eating a nutritious diet that is crucial for diabetes management.

There are many depression treatment options , including medications and therapy. You can still take antidepressants , including selective serotonin reuptake inhibitor SSRI , if you have diabetes.

You can work with a doctor to find the most appropriate medicine for you, though it may take a little trial and error to find what works.

Often, medication and therapy are used together to treat depression. Therapy can help you identify any depression triggers and unhelpful behaviors. Therapy can also provide you with coping strategies and help retrain your thought processes to help you manage your depression.

Aside from medication and therapy, some lifestyle changes can also help you manage depression and diabetes, including:. If you live with diabetes, there are steps to help limit the stress associated with managing the condition, which may help prevent depression or distress.

Diabetes distress can look like depression or anxiety, but unlike these two conditions, medications are not the solution. Instead, the CDC suggests taking other steps to manage your emotional needs, which could help prevent depression as well.

They recommend:. Living with and managing your diabetes can be overwhelming. If you have depression symptoms, talking with healthcare professionals may be helpful. Support groups, such as Diabetes Online Community , can also help. Self-care can feel hard when you live with depression, but these tips can improve your mood and help you manage.

We're exploring the clinical symptoms of depression, plus what signs look like in everyday situations. Your depression treatment options are almost limitless. Medication, therapy, brain stimulation techniques, or self-help strategies could work for you.

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