Abstract
Background:
Diabetes distress is underrecognized and associated with poor outcomes. This study tested whether a 12-month collaborative, goal-setting, and behavioral telehealth intervention reduced diabetes distress levels.
Methods:
This is a secondary analysis of the Healthy Outcomes through Patient Empowerment (HOPE) study that included individuals (N = 225) with uncontrolled diabetes and depression living at least 20 miles from a Veteran's Affairs medical center. Participants were randomized to HOPE (intervention) or Enhanced Usual Care (EUC) with education. We evaluated diabetes distress levels as measured by the Problem Areas in Diabetes (PAID) Questionnaire and its four subscales (emotional, diabetes management, social, and treatment distress) at baseline, 6, and 12 months.
Results:
Between-group analysis revealed greater improvements in HOPE versus EUC for: 6-month PAID total score (p = 0.04), emotional (p = 0.03), and social (p = 0.04) subscales; 12-month PAID total score (p = 0.07) and emotional subscale (p = 0.07). Within-group comparisons showed larger effect sizes for HOPE compared with EUC: 12-month PAID total scores (0.82 vs. 0.54), 6-month emotional burden (0.54 vs. 0.31), and 6-month (0.32 vs. 0.08) and 12-month (0.41 vs. 0.12) social burdens. Repeated-measures analysis evaluating treatment group and time trended toward improvement in PAID overall for HOPE compared with EUC participants, but was not statistically significant (β = 6.96; SE = 4.35; p = 0.13).
Discussion:
Clinically meaningful reductions in PAID overall and the emotional and social subscales were observed in HOPE compared with EUC participants.
Conclusion:
Further evaluation of diabetes telehealth interventions that include other facets related to diabetes distress, including treatment, diabetes management, social, and emotional burdens, is warranted. Clinical Trial Number. NCT01572389; Clinical Trial Registry.
Introduction
Diabetes distress, defined as significant negative psychological responses associated with the emotional burdens specific to managing diabetes, is common, occurring in 38–48% of individuals in community settings. 1 –4 It is attributed to the high demands of diabetes (i.e., glucose monitoring, medication, lifestyle modifications) and results in significant negative patient outcomes, including higher hemoglobin (Hb) A1c, cholesterol, body mass index, and intervals between visits. 5 The 2020 American Diabetes Association standards recommend that providers evaluate for diabetes distress symptoms at baseline and in subsequent visits or when there is a change of disease, therapy, or life circumstance. 2 Although the concepts of diabetes distress have been well-established, 1 –3,6,7 targeted therapies remain undetermined, warranting investigations to reduce patient burdens and negative outcomes. 4,7,8
Diabetes distress is distinguished from other mental health conditions including depression. 1 –4 A study that evaluated 506 individuals with diabetes for major depression disorder, depressive symptoms, and diabetes distress revealed that the latter variable was associated with higher HbA1c levels. 9 Most (70%) participants with high levels of negative mood and psychological distresses were not clinically depressed. 10 The authors concluded that what has been categorized as depression in diabetes may be two conditions, major depressive disorder and diabetes distress, with only the latter affecting glycemic control. 9 Reducing diabetes distress is a critical focus in improved glycemic control and reduced sequelae. 11
The current study is a secondary analysis of the Healthy Outcomes through Patient Empowerment (HOPE) study. 12 HOPE evaluated the efficacy of a 12-month (6-month treatment, 6-month follow-up), collaborative, telehealth (telephonic)-delivered, goal setting and behavioral activation program in people with comorbid diabetes and depression. The study found that the HOPE intervention reduced depression symptoms. 12 The objectives of the current study were to test whether participants in the HOPE study reduced diabetes distress. We compared the baseline, 6-, and 12-month values of the Problem Areas in Diabetes (PAID) total score and its four subscales for individuals randomized to receive HOPE with those in Enhanced Usual Care (EUC) with education (control). Since diabetes distress was not the primary endpoint of HOPE, we also evaluated the differential effect size change in PAID from baseline to 6- and 12-month follow-up. We hypothesized that HOPE would significantly reduce diabetes distress compared with EUC at immediate posttreatment (6 months) and follow-up (12 months).
Methods
The current study was a randomized clinical trial of a structured telehealth intervention for people with uncontrolled diabetes and clinically significant depression symptoms recruited from a regional U.S. Veterans Administration health system (Michael E. DeBakey [MEDVAMC]). The design, procedures, and primary outcomes, depression and HbA1c, of the parent study have been previously reported. 12 Eligible participants were randomized to receive either HOPE or EUC. All participants were asked to complete a series of diabetes and depression-related measures at baseline, immediately posttreatment (6 months), and again at 12-month follow-up. Data collection was conducted by independent evaluators who were blinded to participant group assignment after randomization. The study was conducted by MEDVAMC, which included five hospital-based primary care clinics and eight community-based outpatient clinics throughout Southeast Texas. The Baylor College of Medicine Institutional Review Board and the MEDVAMC Research and Development Committee approved the study protocol.
Inclusion criteria consisted of diabetes (HbA1c ≥58 mmol/mol [7.5%]) and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] ≥10). 13 We chose this glycemic level to allow for a clinically significant (≥5 mmol/mol [0.5%]) decrease in HbA1c to achieve control as defined by the American Diabetes Association. 2,14 The parent study utilized the PHQ-9 to measure depression level since it is a validated tool with minimal administrative training required and is widely used and accepted clinically. 13 Participants were excluded if a telehealth-based coaching intervention would be inappropriate (e.g., severe cognitive impairment or mental health condition, hearing or visual impairment, active suicidal ideation) or if individuals had documentation of severe hypoglycemia and/or substance abuse that would hinder participation. Using the electronic data warehouse from the MEDVAMC, individuals were screened for diabetes by using ICD-9 250.XX codes. Those who met the initial eligibility criteria were contacted by research study staff (bachelor's and master's level research assistants) to complete a full, telehealth baseline assessment to confirm eligibility for clinically significant depression symptoms, defined by PHQ-9 ≥ 10. 13 Individuals who met screening and baseline assessment criteria and desired to participate in the study provided a repeat HbA1c level to ensure levels ≥58 mmol/mol (7.5%). Eligible consented participants were randomized to the intervention or control groups using unequal block randomization (intervention: 60% [n = 136], control: 40% [n = 89]) to increase statistical power for measuring the intervention and factors related to its telehealth delivery in secondary treatment analyses. 12
MEASURES
The PAID questionnaire is a 20-question, patient-reported instrument that is widely used to evaluate diabetes-related psychosocial distress variables (i.e., coping, depression, health benefits, social support). 15 It has internal and construct validity (i.e., discriminant validity of insulin-dependent and nondependent individuals) and reliability across cultures. 15 –17 Each of its 20 items is associated with various areas of diabetes-related psychosocial distress, including coping, depression, health benefits, and social support. Using a five-point Likert scale, survey items are rated in severity (0 = no problem to 4 = serious problem). The total scale score is then summed and multiplied by a factor of 1.25, yielding a minimum of 0 to a maximum of 100 total score. Higher scores are associated with a greater level of diabetes distress. 15
We recently stratified the key variables of PAID into four subscales, to widen assessments and enhance medical and behavioral health therapy. 18 The four areas include the following: emotional (eight items: depressed, scared, overwhelmed, angry, worry, mental/physical energy, mood/feelings, acceptance), diabetes management (five items: eating, guilt/anxiety, burn out, food deprivation, social situations), social support (two items: feeling alone, poor friend/family support), and treatment (three items: discouraged, unclear goals, unsatisfied with providers). 18
INTERVENTION
Participants were randomized to HOPE (intervention) or to EUC (control). In addition to usual care in the clinic, control participants received enhanced care with an assessment for distress and depression symptoms (PAID and PHQ-9), documentation of these symptoms in their medical record, and educational materials on depression and anxiety. HOPE participants received a collaborative, goal-setting “active” intervention for the first 6 months that occurred biweekly (30–40 min) for sessions 1–3 and monthly (15 min) for sessions 4–6. Then they received three, bimonthly maintenance sessions of 15 min during months 7–12. All sessions were telephone-based (without video, text, etc.). 12
HOPE's sessions were led by trained health care professional “coaches” (i.e., nurses, social workers, psychologists, clinical pharmacists). Coaches were trained through two, 2-hour teleconference sessions and received ongoing support by a behavioral health expert in addition to monthly peer mentoring. Intervention module topics included building rapport, goal setting, engaging in positive lifestyle activities, healthy eating, relaxation, managing negative thoughts, and medication management. To guide telephone conversations and track progress, coaches and participants used a structured clinician manual with optional scripts and patient workbooks during their sessions to guide telephone conversations and track progress. 12
All study procedures (screening, surveys, educational sessions, follow-up assessments) were conducted by telehealth for ease of treatment burden. Participants from both study arms came to the site only to obtain HbA1c measurements and their usual medical care. Educational materials on diabetes control and behavioral manifestations were mailed to EUC participants.
STATISTICAL ANALYSES
Primary analyses focused on repeated measures nested by clinic site accounting for all time points (baseline, 6, 12 months) within a single model. A significant value for time-by-treatment interactions would indicate a significant difference between the HOPE and EUC groups over time. We also evaluated clinical changes between and within groups on the PAID total and subscale scores, examining the change scores for the outcomes and testing for differences between HOPE and EUC. The 6-month change score for each patient was calculated as the 6-month value minus the baseline value. A negative value would indicate that the patient had less distress at 6 months relative to baseline. We tested for differences in the means between the two randomized groups for each outcome using the pooled t-test when the variances were equal and the Satterthwaite approximation when variances were unequal. These analyses were repeated using 12-month change scores.
To evaluate specific individual patterns of diabetes distress that may not have been evident within between-group analyses, 19,20 within-group comparisons were performed. The means, standard deviations, and effect size calculations were also conducted at the 6- and 12-month time points to examine within-group changes for HOPE and EUC. Contrasts between baseline and 6 months and baseline and 12 months tested for differences in the outcomes at the follow-up time periods. Cohen's effect size (d) was defined as the absolute value of the mean of the change score for HOPE participants minus the mean of the change score for EUC participants divided by the pooled standard deviation. Effect sizes were defined as small (0.2), medium (0.5), or large (0.8), and p-values <0.05 were considered statistically significant. 21
Results
Full description of participant screening, recruitment, and randomization is described elsewhere. 12 A final sample of 225 subjects met the study criteria and provided informed consent. Figure 1 describes participant flow and retention at 6 and 12 months in addition to PAID assessment completion.

CONSORT diagram of patient flow. EUC, Enhanced Usual Care; HOPE, Healthy Outcomes through Patient Empowerment; PAID, Problem Areas in Diabetes.
Table 1 describes the baseline characteristics of the study population; there were no significant baseline differences between groups. The average age of participants was 61.9 years old (SD ±8.3) and most were married (64.4%) and men (89.8%). The majority completed some or all of college (68.9%) and many were disabled (40.9%) or retired (32.9%). There were also no significant clinical differences between groups at baseline. The mean HbA1c was 77.9 mmol/mol (9.3%) and the average PHQ-9 score was 15.9 (moderate depressive symptoms). Most participants viewed their health as fair to poor (76.9%) (Table 1).
Demographic Characteristics of the Sample 6 Months Before Baseline
p-Values are for testing if the groups differed at baseline. For continuous variables, the p-value is based on the t-test and for categorical variables it is based on the chi-square test.
EUC, enhanced usual care; HOPE, Healthy Outcomes through Patient Empowerment; PHQ-9, Patient Health Questionnaire-9.
Almost all (92%) of HOPE participants completed at least one of the six educational sessions, and the majority (51%) completed all six. Most (73%) completed at least half (3/6) of the active sessions. Nearly half (46%) completed all six active and one maintenance session, but the minority (27%) finished all nine. Reasons for not completing the sessions included unable to contact the participant or not interested. During months 1–6, if coaches could not reach an individual during a given month, they provided the prior month's educational session at the next point of contact. We did not experience that HOPE participants had phone connectivity issues that resulted in phone disconnection during coaching session and an incomplete session.
Repeated-measures analysis assessing the interaction between treatment group and time revealed a trend toward improvement in PAID overall for HOPE compared with EUC participants, but was not statistically significant (β = 6.96; SE = 4.35; p = 0.13). However, HOPE participants experienced a steady decline in PAID scores from baseline (mean [SD], 48.2 [20.9]) to 6 months (35.2 [22.8]) and to 12 months (30.8 [21.5]). EUC participants had a similar but more modest change from baseline (49.5 [17.3]) to 6 months (40.9 [20.6]) that plateaued at 12 months (39.1 [21.7]). Differences between HOPE and EUC were modest at 6 months (mean difference, 4.29; confidence interval [95% CI], −1.44 to 10.0; p = 0.15) and became significant at 12 months (mean difference, 7.04; 95% CI, 1.41–12.66; p = 0.01). Figure 2 demonstrates the change in PAID scores across all time points stratified by group.

Comparison of the PAID total score at baseline, 6, and 12 months for the intervention (HOPE) and control (EUC) groups.
Table 2 illustrates the within-group findings for the PAID questionnaire. Overall, both groups made incremental changes on the PAID total score and the four subscales from baseline to 6 and 12 months. The only exception was the diabetes management burden subscale where the EUC arm remained unchanged after 6 months. HOPE participants had larger 6- and 12-month effect sizes compared with the EUC arm for the PAID total score and all subscales, except the 6-month treatment burden (Table 2). Both groups resulted in statistically significant changes at 6 and 12 months except for the EUC social subscale, which was not significant at either time point (p = 0.587, p = 0.446, respectively).
PAID Total Scores and Subscales at Baseline, 6 Months, and 12 Months for the Intervention (Healthy Outcomes Through Patient Empowerment) and Control (Enhanced Usual Care) Groups
Group effect size for 6 months compared with baseline for HOPE = mean of the outcome at 6 months for HOPE − mean of the outcome at baseline for HOPE| divided by the pooled standard deviation.
Group effect size for 6 months compared with baseline for EUC = |mean of the outcome at 6 months for EUC − mean of the outcome at baseline for EUC| divided by the pooled standard deviation.
p-Value is for the comparison of 6 months with baseline from the repeated-measures model that tested for difference over time in the outcome.
Group effect size for 12 months compared with baseline for HOPE = |Mean of the outcome at 12 months for HOPE − mean of the outcome at baseline for HOPE| divided by the pooled standard deviation.
Group effect size for 12 months compared with baseline for EUC = |Mean of the outcome at 12 months for EUC − Mean of the outcome at baseline for EUC| divided by the pooled standard deviation.
p-Value is for the comparison of 12 months with baseline from the repeated-measures model that tested for difference over time in the outcome. Effect sizes were defined as small (0.2), medium (0.5), or large (0.8). 21
PAID, Problem Areas in Diabetes.
Table 3 compares changes over time in the PAID scores between HOPE and EUC. At 6 months, HOPE participants had significantly greater improvements for the total score (p = 0.04) and two subscales (emotional and social burden; p = 0.03, p = 0.04, respectively). There were no significant findings for the diabetes management or treatment burden subscales at 6 months.
Comparison of the PAID Total Score and Subscale Change Scores at 6 and 12 Months for the Intervention (Healthy Outcomes Through Patient Empowerment) and Control (Enhanced Usual Care) Groups
Six-month score minus baseline score. A negative value indicates less distress at 6 months compared with baseline.
Twelve-month score minus baseline. A negative value indicates less distress at 12 months compared with baseline. p-Value is the difference in change scores between HOPE and EUC from t-test.
Discussion
This randomized clinical trial examined the impact of a collaborative, goal-setting intervention delivered by telehealth (HOPE) on diabetes distress in a sample of high-risk participants with comorbid uncontrolled diabetes and depression. Time-to-treatment analysis favored HOPE more than EUC participants in PAID overall, but was not statistically significant. However, analyses of clinical elements revealed greater effect size changes for HOPE participants on the PAID total score and the social and emotional burden subscales at 6 and 12 months compared with EUC individuals. In addition, quantitative change analysis at 6 months found statistically significant improvements in the overall PAID and the social and emotional burden subscale scores for HOPE versus EUC. This study is clinically meaningful as it provides a modality to address diabetes distress using telehealth-delivered interventions with high-risk populations, specifically related to emotion and social burdens.
We do not think that the time-to-treatment analysis result reflects the impact of HOPE on diabetes distress. The study was not designed or powered for detecting changes in this outcome, and the time-to-treatment analysis was not adequately powered to detect change despite the reasonable effect size differences. The higher loss to follow-up in the HOPE group at 12 months likely reduced our capacity to measure change. In addition, the quantitative differences at 12 months between HOPE and EUC were significant and clinically important. Furthermore, the effects of the study were likely muted for several reasons. These include notification of EUC providers of participants with elevated PHQ-9 scores and HbA1c levels at baseline, likely resulting in increased contact and thereby intervention. 12 Also, not all HOPE participants could be contacted every session, and therefore, some individuals received an impartial intervention.
Prior studies have identified PAID scores greater than 40 as suggestive of clinically significant distress. 22 At baseline, both groups had mean scores above this threshold. EUC participants reached, on average, just below this threshold at 12 months, whereas most HOPE participants experienced improvements well below this threshold by 6 months. Most HOPE participants appeared to have a clinically significant improvement postintervention that persisted over time. Prior studies of collaborative goal-setting have demonstrated sustained improvements in clinical outcomes over 12 months compared with regression to mean among usual care participants. 12,23
Although prior studies have shown the value of the PAID questionnaire in evaluating diabetes distress, 15,18 this study included its subscales to enhance clinical recognition and assist in targeting therapies. Identifying the constituents or subscales of distress in diabetes is valuable in clinical management to determine the effectiveness of treatment. Specifically, the 6-month social and emotional subscale data analyses showed greater improvements for the HOPE participants than the EUC group. Individuals with diabetes are vulnerable and at risk for social isolation, leading to negative mental health impacts. 24 The design of the study including population screening for depression and the telehealth nature of the intervention were specifically targeted to this group. These subscale improvements may reflect HOPE's curriculum and structure; HOPE elicited patient-driven goals that might have impacted diabetes distress in addition to frequent, accessible telehealth encounters with health care professionals. This aligns with other studies that have demonstrated that spending time with people is essential to improve health care outcomes and health literacy. 25,26
The diabetes management subscale (i.e., eating, food deprivation, guilt/anxiety) did not result in a significant difference between groups. Future studies may enhance HOPE by detailing diabetes management topics such as burn out or more in-depth nutritional series are warranted to address these needs. In addition, other forms of telehealth, including group videoconferencing, may be valuable to augment the topics and provide further social interaction. Furthermore, it is not surprising that the treatment burden decreased similarly for both groups. There were no additional physician encounters for medication management in HOPE, and therefore, both groups would have received similar opportunities for treatment as part of their usual primary care.
LIMITATIONS
Participants were primarily men from one regional area, which limits generalizability. The U.S. Veterans Administration health system is a national, integrated, and multidisciplinary network consisting predominantly of men. Therefore, the observed impact may not translate to other health systems. There is self-selection bias given the eligibility criteria of the parent study, including uncontrolled diabetes and significant depression symptoms. The study excluded individuals with diabetes distress who did not have depression, and did not obtain its target number of participants at baseline, which may have hindered data analyses. Furthermore, analyzing only those who completed the study may have resulted in confirmation bias.
Conclusion
This study highlights the ability to address diabetes distress using telehealth-delivered interventions with high-risk populations. The results demonstrate that the PAID questionnaire subscales provide insight into the treatment of diabetes-related depression. While emotional and social burdens may decrease as a result of the HOPE intervention, treatment burdens were not adequately targeted. Future studies of diabetes telehealth interventions should target other facets of diabetes distress, including treatment and diabetes management, and social and emotional burdens.
Footnotes
Authors' Contributions
All authors and coauthors assume responsibility and accountability for the study results and have participated in significant portions of the article, including writing (E.V., A.N., N.P., and J.C.), reviewing (E.V., A.N., N.P., J.C., N.H., D.Z., and M.K.), and revising intellectual and technical content (E.V., A.N., N.P., J.C., N.H., D.Z., and M.K.).
Disclosure Statement
No competing financial interests exist.
Funding Information
This work was supported by a grant from the Veterans Health Administration Health Services Research and Development Office (grant #10–135; Cully and Naik, MPI) and the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases (grant #DK110341; Vaughan, PI). The work was also supported using facilities and resources of the VA HSR&D Center for Innovations in Quality, Effectiveness, and Safety (CIN13–413).
