Enhanced Usual Care Research Articles

Effect of Telephone-Delivered Collaborative Goal Setting and Behavioral Activation vs Enhanced Usual Care for Depression Among Adults With Uncontrolled Diabetes

Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care. To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression. In this randomized clinical trial, 225 participants (intervention [n = 136] and control [n = 89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire-9 scores [PHQ-9] ≥10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat. Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status. Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures. Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (β, 1.56; 95% CI, -0.68 to 3.81; P = .17) or HbA1c (β, -0.005; 95% CI, -0.73 to 0.72; P = .82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of -0.06% (95% CI, -0.61% to 0.50%; P = .83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P = .01). Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care. ClinicalTrials.gov identifier: NCT01572389.

Psychological treatments for depression among women experiencing intimate partner violence: findings from a randomized controlled trial for behavioral activation in Goa, India

Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation.

Computer-Assisted Cognitive-Behavioral Therapy to Treat Adolescents With Depression in Primary Health Care Centers in Santiago, Chile: A Randomized Controlled Trial.

Introduction: Evidence from developed countries shows the efficacy of computer-assisted cognitive-behavioral therapy (cCBT) in addressing adolescent depression in home and/or school settings. This paper presents the results of a randomized controlled trial (RCT) of a brief therapist-guided cCBT intervention for adolescent depression in resource-constrained primary health care (PHC) settings. Material and methods: A multicenter, two-arm parallel-group, individually RCT with a 1:1 allocation ratio assigned 216 depressed adolescents (aged 15–19) attending four PHC centers in a low-income municipality of Santiago, Chile, to receive eight weekly face-to-face therapist-guided cCBT sessions by study therapists (N = 108), or to receive an enhanced usual care (EUC) intervention by trained PHC psychologists, encouraged to adhere to the national clinical guidelines for the management of depression (N = 108). Both groups received pharmacotherapy concordant with these guidelines. The primary outcome was the Beck Depression Inventory (BDI) at 4 months post-randomization, to assess depressive symptoms. BDI at 6 months post-randomization was a secondary outcome. Additional measures included patients’ compliance, and satisfaction with different treatment components, at 6 months post-randomization. Main Results: The adjusted difference in mean BDI score between groups was -3.75 (95% CI -6.23 to -1.28; p = 0.003) at 4 months post-randomization. At 6 months post-randomization, the adjusted difference in mean BDI score between groups was -2.31 (95% CI -4.89 to 0.27; p = 0.078). The effect size was small-to-medium at 4 months post-randomization, d = 0.39 (0.12 to 0.67), and small and non-significant at 6 months post-randomization d = 0.29 (-0.00 to 0.59). Adolescents in the experimental treatment group were significantly more satisfied with treatment, with the PHC centers’ facilities, with the psychological care received, and with non-professional staff than those in the comparator treatment group. Discussion: A brief therapist-guided cCBT eight-session intervention improves the response of depressed adolescents attending PHC centers at 4 months post-randomization. At 6 months post-randomization, the differences of between groups were not significant. Future research may focus on exploring strategies to sustain and increase response. Clinical trial registration: www.ClinicalTrials.gov, identifier NCT01862913 and URL: https://clinicaltrials.gov/ct2/show/NCT01862913.

Glucose management for rewards: A randomized trial to improve glucose monitoring and associated self-management behaviors in adolescents with type 1 diabetes.

This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes. After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks. Participants in the reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps < .01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5% ± 1.2% at baseline to 9.0% ± 1.3% at week 6 and 9.0% ± 1.4% at week 12. For EUC, A1c was 9.2% ± 0.2% at baseline and ranged from 9.2% ± 1.5% to 9.6% ± 1.6% throughout the study (P < .05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement. Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.

Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study

IntroductionOver one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC). MethodWe have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18–69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes. ConclusionIf GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.

206-OR: A Randomized Controlled Trial to Improve Self-Monitoring of Blood Glucose among Youth with Type 1

Objective: This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring blood glucose (SMBG) among youth with poorly controlled type 1 diabetes. SMBG frequency was the primary outcome, A1c was the secondary outcome. Methods: After a 2-week baseline, 60 youth age 12-19 years with &amp;lt;4 BG checks per day and A1c &amp;gt;7.5% but ≤13% were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters, completing pattern recognition forms, and reviewing results with clinicians. Reinforcers were withdrawn at 24 weeks. A follow-up evaluation occurred at 36 weeks. Results: Randomization produced groups that did not differ on any demographic or clinical characteristics. Participants in the Reinforcers group increased the proportion of days they completed ≥4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24 weeks, respectively. In contrast EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (ps&amp;lt;0.01 versus EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the Reinforcers group, mean A1c dropped from 9.5±1.2% at baseline to 9.0±1.3% at week 6 and 9.0±1.4% at week 12. For EUC, A1c was 9.2%±0.2 at baseline and ranged from 9.2±1.5% to 9.6±1.6% throughout the study (p&amp;lt;0.05 versus EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement. Conclusions: Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group. Disclosure J. Wagner: None. K. Weyman: None. E.M. Tichy: None. E. Cengiz: Advisory Panel; Self; Abvance, ADOCIA, MannKind Corporation, Novo Nordisk Inc. Speaker's Bureau; Self; Novo Nordisk Inc. K. Zajac: None. W.V. Tamborlane: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic MiniMed, Inc., Novo Nordisk Inc., Sanofi, Takeda Pharmaceutical Company Limited.

856-P: Can Monetary-Based Reinforcement for Self-Monitoring Blood Glucose (SMBG) Impact Psychosocial Outcomes? A Randomized Controlled Trial

Background: Members of our group previously reported that monetary reinforcement of SMBG related behaviors shows robust increases in frequency of SMBG and modest decreases in A1c among youth with type 1 diabetes (T1D). In these secondary data analyses, we explored effects on psychosocial functioning. Methods: Sixty youth ages 12-21 (Mage=15.58, SD=2.31) with T1D, A1c 7.5-13%, and &amp;lt;4 BG checks per day were randomized to either a 24-week reinforce intervention or enhanced usual care (EUC). The intervention consisted of monetary incentives for completing blood glucose checks, texts with provider, glucose data uploads, and glucose pattern recognition forms. Validated psychosocial questionnaires were administered at baseline, 6, 12, 24, and 36 weeks. Measures included youth reported diabetes distress, family conflict, and negative affective responses to out-of-range glucose results. Results: Generalized linear models showed no significant time x condition effects. In t-tests at discrete follow-ups, compared to the control group, the reinforce group had significantly lower youth-reported diabetes related family conflict at 12 weeks (22.39 vs. 25.11, p=.043) and significantly higher negative affective responses to out-of-range glucose results at 24 weeks (13.62 vs. 11.71, p=.047). Conclusion: Monetary reinforcers targeting SMBG behaviors may produce transitory decreases in youth perceptions of family conflict and transitory iatrogenic increases in youth’s negative affective responses to out-of-range glucose results. The timing of changes in family conflict, negative affect, and previously reported changes in A1c suggest that psychosocial changes may reflect youth responses to A1c as well as to reinforcers per se. For broader effects, the intervention could include psychosocial components that seek to directly maintain decreased family conflict and mitigate negative affect related to increased awareness of glucose control. Disclosure J.J. Wong: None. A. Addala: None. K.K. Hood: Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc. Speaker's Bureau; Self; Johnson &amp; Johnson Diabetes Institute. J. Wagner: None. E. Cengiz: Advisory Panel; Self; Abvance, ADOCIA, MannKind Corporation, Novo Nordisk Inc. Speaker's Bureau; Self; Novo Nordisk Inc. E.M. Tichy: None. K. Weyman: None. D. Naranjo: Advisory Panel; Spouse/Partner; Eli Lilly and Company. Speaker's Bureau; Spouse/Partner; Johnson &amp; Johnson Diabetes Institute. Other Relationship; Self; Abbott. Funding National Institutes of Health

Long term effectiveness of dialectical behavior therapy versus enhanced usual care for adolescents with self-harming and suicidal behavior.

Knowledge is lacking on the long-term outcomes of treatment for adolescents with repetitive suicidal and self-harming behavior. Furthermore, the pathways through which treatment effects may operate are poorly understood. Our aims were to investigate enduring treatment effects of dialectical behavior therapy adapted for adolescents (DBT-A) compared to enhanced usual care (EUC) through a prospective 3-year follow-up and to analyze possible mediators of treatment effects. Interview and self-report data covering the follow-up interval were collected from 92% of the adolescents who participated in the original randomized trial. NCT01593202 (www.ClinicalTrials.gov). At the 3-year follow-up DBT-A remained superior to EUC in reducing the frequency of self-harm, whereas for suicidal ideation, hopelessness and depressive and borderline symptoms and global level of functioning there were no inter-group differences, with no sign of symptom relapse in either of the participant groups. A substantial proportion (70.8%) of the effect of DBT-A on self-harm frequency over the long-term was mediated through a reduction in participants' experience of hopelessness during the trial treatment phase. Receiving more than 3months follow-up treatment after completion of the trial treatment was associated with further enhanced outcomes in patients who had received DBT-A. There were on average no between-group differences at the 3-year follow-up in clinical outcomes such as suicidal ideation, hopelessness, depressive and borderline symptoms. The significantly and consistently larger long-term reduction in self-harm behavior for adolescents having received DBT-A compared with enhanced usual care, however, suggests that DBT-A may be a favorable treatment alternative for adolescents with repetitive self-harming behavior.

Effect of a stepped-care intervention delivered by lay health workers on major depressive disorder among primary care patients in Nigeria (STEPCARE): a cluster-randomised controlled trial

SummaryBackgroundLittle is known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. We aimed to compare a stepped-care intervention package for depression with usual care enhanced by use of the WHO Mental Health Gap Action Programme intervention guide (mhGAP-IG).MethodsWe did a cluster-randomised trial in primary care clinics in Ibadan, Nigeria. Eligible clinics were those with adequate staffing to provide various 24-h clinical services and with regular physician supervision. Clinics (clusters), anonymised and stratified by local government area, were randomly allocated (1:1) with a computer-generated random number sequence to one of two groups: an intervention group in which patients received a stepped-care intervention (eight sessions of individual problem-solving therapy, with an extra two to four sessions if needed) plus enhanced usual care, and a control group in which patients received enhanced usual care only. Patients from enrolled clinics could participate if they were aged 18 years or older, not pregnant, and had moderate to severe depression (scoring ≥11 on the nine-item patient health questionnaire [PHQ-9]). The primary outcome was the proportion of patients with remission of depression at 12 months (a score of ≤6 on the PHQ-9, with assessors masked to group allocation) in the intention-to-treat population. This trial is registered with the International Standard Randomised Controlled Trials Number registry (ISRCTN46754188) and is completed.Findings35 of 97 clinics approached were eligible and agreed to participate, of which 18 were allocated to the intervention group and 17 to the control group. 1178 patients (631 [54%] in the intervention group and 547 [46%] in the control group) were recruited between Dec 2, 2013, and June 29, 2015, among whom 976 (83%) were female and baseline mean PHQ-9 score was 13·7 (SD 2·6). Of the 562 (89%) patients in the intervention group and 473 (86%) in the control group who completed 12-month follow-up, similar proportions in each group had remission of depression (425 [76%] in the intervention group vs 366 [77%] in the control group; adjusted odds ratio 1·0 [95% CI 0·70–1·40]). At 12 months, 17 (3%) deaths, one (<1%) psychotic illness, and one (<1%) case of bipolar disorder in the intervention group, and 16 deaths (3%) and one (<1%) case of bipolar disorder in the control group were recorded. No adverse events were judged to be related to the study procedures.InterpretationFor patients with moderate to severe depression receiving care from non-physician primary health-care workers in Nigeria, a stepped-care, problem-solving intervention combined with enhanced usual care is similarly effective to enhanced usual care alone. Enhancing usual care with mhGAP-IG might provide simple and affordable approach to scaling up depression care in sub-Saharan Africa.FundingUK Medical Research Council.

Feasibility, acceptability and cost-effectiveness of a brief, lay counsellor-delivered psychological treatment for men with alcohol dependence in primary care: an exploratory randomized controlled trial.

AimsTo examine the feasibility, acceptability and preliminary cost‐effectiveness of a lay counsellor delivered psychological treatment for men with alcohol dependence in primary care.DesignSingle‐blind individually randomized trial comparing counselling for alcohol problems (CAP) plus enhanced usual care (EUC) versus EUC only.SettingTen primary health centres in Goa, India.ParticipantsMen (n = 135) scoring ≥ 20 on the Alcohol Use Disorder Identification Test (AUDIT). Sixty‐six participants were randomized to EUC and 69 to CAP + EUC.InterventionsCAP, a lay counsellor‐delivered psychological treatment for harmful drinking, with referral to de‐addiction centre for medically assisted detoxification. EUC comprised consultation with physician, providing screening results and referral to a de‐addiction centre.MeasurementsBaseline socio‐demographic data, readiness to change and perceived usefulness of counselling. Acceptability and feasibility process indicators such as data on screening and therapy. Outcomes were measured at 3 and 12 months post‐randomization and included remission, mean daily alcohol consumed, percentage of days abstinent (PDA), percentage of days of heavy drinking (PDHD), recovery, uptake of detoxification services, impacts of alcohol dependence, resource use and costs.FindingsParticipants in the CAP + EUC arm had more numerically but not statistically significantly favourable outcomes compared with those in the EUC arm for (a) remission at 3 months [adjusted odds ratio (aOR) = 1.95, 95% confidence interval (CI) = 0.74–5.15] and 12 months (aOR = 1.90, 95% CI = 0.72–5.00), (b) proportion of non‐drinkers at 3 months (aOR = 1.26; 95% CI = 0.58–2.75) and 12 months (aOR = 1.25; 95% CI = 0.58–2.64) and (c) ethanol consumption among drinkers at 3 months (count ratio = 0.91; 95% CI = 0.58–1.45) and 12 months (count ratio = 1.06; 95% CI = 0.73–1.54). There was no statistically significant evidence of a difference in the occurrence of serious adverse events between the two arms. From a societal perspective, there was a 53% chance of CAP + EUC being cost‐effective in achieving remission at 12 months at the willingness‐to‐pay threshold of $415.ConclusionsLay counsellor‐delivered psychological treatment for men with alcohol dependence (AD) in primary care may be effective in managing AD in low‐ and middle‐income countries. A definitive trial of the intervention is warranted.

Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic

BackgroundWomen are at highest risk for development of a substance use disorder during their reproductive years. We recently evaluated the efficacy of an electronic screening, brief intervention and referral to treatment (e-SBIRT) and a clinician-delivered SBIRT (SBIRT) compared with enhanced usual care (EUC) for reducing overall substance use among women recruited from reproductive health clinics. The present study assessed the impact of the SBIRT interventions within three primary substance subgroups: cigarettes, illicit drugs, and alcohol. MethodsThis is a secondary analysis from a 3-group randomized trial comparing e-SBIRT and SBIRT to EUC. For the present study, participants (N = 439) were grouped according to their primary substance: cigarettes, alcohol, or illicit drugs. Differences in days per month of primary substance use over time between treatment groups were examined using generalized estimating equations, modelling linear as well as quadratic effects of time. ResultsCigarettes were the most frequently reported primary substance (n = 251), followed by illicit drugs (n = 137) and alcohol (n = 51). For primary cigarette use the interaction between the linear effect of time and treatment was significant for SBIRT (β (SE) = −0.067 (0.029), p = .020), but not e-SBIRT, suggesting greater reductions in cigarette use over the first 3 months following treatment with SBIRT compared to EUC. However, the significant interaction of SBIRT with time-squared (β (SE) = 0.009 (0.004), p = .049) showed that reductions in cigarette use attenuated over time, such that after month 3, monthly reductions in cigarette use were similar between groups. Results followed a similar pattern for primary illicit drug use among the e-SBIRT group in which the interaction of e-SBIRT treatment with linear time (β (SE) = −0.181 (0.085), p = .033) and quadratic time (β (SE) = 0.028 (0.012), p = .018) were statistically significant suggesting greater reductions in illicit drug use with e-SBIRT versus EUC, which attenuated with time. Neither SBIRT nor e-SBIRT was associated with a significant reduction in days of alcohol use per month, as compared to EUC. ConclusionsReproductive-age women appear to respond differently to electronic- and clinician-delivered interventions, depending on their primary substance. SBIRT reduced use of cigarettes, and e-SBIRT reduced illicit drug use. Although neither intervention reduced primary alcohol use, the sample size was small (n = 51), suggesting a need for further testing in a larger sample.

Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial

Many women are affected by anxiety and depression after armed conflict in low-income and middle-income countries, yet few scalable options for their mental health care exist. We aimed to establish the effectiveness of a brief group psychological intervention for women in a conflict-affected setting in rural Swat, Pakistan. In a single-blind, cluster, randomised, controlled trial, 34 community clusters in two union councils of rural Swat, Pakistan, were randomised using block permutation at a 1:1 ratio to intervention (group intervention with five sessions incorporating behavioural strategies facilitated by non-specialists) or control (enhanced usual care) groups. Researchers responsible for identifying participants, obtaining consent, enrolment, and outcome assessments were masked to allocation. A community cluster was defined as neighbourhood of about 150 households covered by a lady health worker. Women aged 18-60 years who provided written informed consent, resided in the participating cluster catchment areas, scored at least 3 on the General Health Questionnaire-12, and at least 17 on the WHO Disability Assessment Schedule were recruited. The primary outcome, combined anxiety and depression symptoms, was measured 3 months after the intervention with the Hospital Anxiety and Depression Scale (HADS). Modified intention-to-treat analyses were done using mixed models adjusted for covariates and clusters defined a priori. The trial is registered with the Australian New Zealand Clinical Trials Registry, number 12616000037404, and is now closed to new participants. From 34 eligible community clusters, 306 women in the intervention group and 306 women in the enhanced usual care (EUC) group were enrolled between Jan 11, 2016, and Aug 21, 2016, and the results of 288 (94%) of 306 women in the intervention group and 290 (95%) of 306 women in the EUC group were included in the primary endpoint analysis. At 3 months, women in the intervention group had significantly lower mean total scores on the HADS than women in the control group (10·01 [SD 7·54] vs 14·75 [8·11]; adjusted mean difference [AMD] -4·53, 95% CI -7·13 to -1·92; p=0·0007). Individual HADS anxiety scores were also significantly lower in the intervention group than in the control group (5·43 [SD 4·18] vs 8·02 [4·69]; AMD -2·52, 95% CI -4·04 to -1·01), as were depression scores (4·59 [3·87] vs 6·73 [3·91]; AMD -2·04, -3·19 to -0·88). No adverse events were reported in either group. Our group psychological intervention resulted in clinically significant reductions in anxiety and depressive symptoms at 3 months, and might be a feasible and effective option for women with psychological distress in rural post-conflict settings. WHO through a grant from the Office for Foreign Disaster Assistance.

Trust and Glycemic Control in Black Patients With Diabetic Retinopathy: A Pilot Study.

Diabetic retinopathy (DR) is more prevalent in blacks than whites because, compared to whites, blacks on average have worse glycemic control. Both of these racial disparities reflect differences in sociocultural determinants of health, including physician mistrust. This randomized, controlled 6-month pilot trial compared the efficacy of a culturally tailored behavioral health/ophthalmologic intervention called Collaborative Care for Depression and Diabetic Retinopathy (CC-DDR) to enhanced usual care (EUC) for improving glycemic control in black patients with DR (n = 33). The mean age of participants was 68 years (SD 6.1 years), 76% were women, and the mean A1C was 8.7% (SD 1.5%). At baseline, 14 participants (42%) expressed mistrust about ophthalmologic diagnoses. After 6 months, CC-DDR participants had a clinically meaningful decline in A1C of 0.6% (SD 2.1%), whereas EUC participants had an increase of 0.2% (SD 1.1%) (f[1, 28] = 1.9; P = 0.176). Within CC-DDR, participants with trust had a reduction in A1C (1.4% [SD 2.5%]), whereas participants with mistrust had an increase in A1C (0.44% [SD 0.7%]) (f[1, 11] = 2.11; P = 0.177). EUC participants with trust had a reduction in A1C (0.1% [SD 1.1%]), whereas those with mistrust had an increase in A1C (0.70% [SD 1.1%]) (f[1, 16] = 2.01; P = 0.172). Mistrust adversely affected glycemic control independent of treatment. This finding, coupled with the high rate of mistrust, highlights the need to target mistrust in new interventions to improve glycemic control in black patients with DR.

Improving Patient Reported Outcomes and Preventing Depression and Anxiety in Older Adults With Knee Osteoarthritis: Results of a Sequenced Multiple Assignment Randomized Trial (SMART) Study

Older adults with knee osteoarthritis (OA) and comorbid subsyndromal depressive symptoms are at elevated risk for incidental major depression or anxiety disorders. Using an indicated prevention paradigm, the authors conducted a sequenced multiple assignment randomized trial (SMART) to: 1) evaluate the effect of cognitive behavioral therapy (CBT) and physical therapy (PT), together with the temporal ordering of these interventions, on patient-reported global impression of change (P-GIC), mood, anxiety, and pain; and 2) compare the strategies' impact on incidence of common psychiatric disorders over 12-months. This intervention development trial compared four adaptive strategies delivered in two stages (each up to 8 weeks), contrasted with enhanced usual care (EUC). The strategies were CBT followed by an increased dose of CBT (CBT-CBT), CBT followed by PT (CBT-PT), PT followed by an increased dose of PT (PT-PT), and PT followed by CBT (PT-CBT). Participants (n = 99) were aged 60 years and older and met clinical criteria for knee OA and subthreshold depression. Response was defined as at least "much better" on the P-GIC. Participants were assessed quarterly for 12 months for incidence of psychiatric disorders. Stage 1 response was higher for PT (47.5%) compared to CBT (20.5%). Non-responders receiving an additional dose of the same intervention experienced a response rate of 73%, higher than for switching to a different intervention. All strategies were superior to EUC (5%). Although not powered to detect effects on disorders, neither intervention strategy nor response status affected 12-month incidence of depression and anxiety disorders. As response rates were similar for PT-PT and CBT-CBT, it may be dose and not type of these interventions that are necessary for clinical benefit. For non-responders, this finding may guide providers to stay the clinical course for up to 12 weeks before switching. These results support future trials of SMART designs in late-life depression prevention.

A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial

BackgroundGoals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA’s intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC). Our secondary aim was to test the impact of GEM on weight, diet and physical activity when compared to EUC.MethodsVeterans with a Body Mass Index ≥30 kg/m2 or 25–29.9 kg/m2 with comorbidities (n = 45) were recruited in two phases and randomized to GEM (n = 22) or EUC (n = 23). We collected process measures (e.g. number of coaching calls completed, number and types of lifestyle goals, counseling documentation) and qualitative feedback on quality of counseling and acceptability of call duration. We also measured weight and behavioral outcomes.ResultsGEM participants reported receiving high quality counseling from health coaches and that call duration and frequency were acceptable. They received 5.9 (SD = 3.7) of 12 coaching calls on average, and number of coaching calls completed was associated with greater weight loss at 6-months in GEM participants (Spearman Coefficient = 0.71, p < 0.001). Four participants from GEM and two from EUC attended the MOVE! program. PCPs completed clinical reminders in 12% of PCP visits with GEM participants. Trends show that GEM participants (n = 21) tended to lose more weight at 3-, 6-, and 12-months as compared to EUC, but this was not statistically significant. There were no significant differences in diet or physical activity.ConclusionsWe found that a technology assisted health coaching intervention delivered within primary care using student health coaches was feasible and acceptable to Veteran patients. This pilot study helped elucidate challenges such as low provider engagement, difficulties with health coach continuity, and low patient attendance in MOVE! which we have addressed and plan to test in future studies.Trial registrationNCT03006328 Retrospectively registered on December 30, 2016.

A Pilot Randomized Controlled Trial of a Telenutrition Weight Loss Intervention in Middle-Aged and Older Men with Multiple Risk Factors for Cardiovascular Disease.

Overweight and obesity threaten the health, functionality and quality of life of 77.2% men in West Virginia. The purpose of this study was to evaluate the feasibility and effectiveness of a 12-week primary care referred telenutrition weight loss intervention. Fifty-nine 40–70-year-old men with obesity were randomized to either the intervention group (n = 29) or an enhanced usual care (EUC) (n = 30) group. Participants from both groups were prescribed a moderate energy restricted diet (500–750 kcal/day below energy requirements) and provided diet-related educational materials; but, only those in the intervention group received weekly support from a registered dietitian nutritionist via telephone and videoconferencing. Both groups significantly reduced body weight, waist circumference, percent body fat and caloric intake and improved diet quality from baseline (p < 0.0001). Groups did not differ after controlling for time (all p > 0.30) and none of the group by time interactions were statistically significant. At week 12, a greater proportion of participants from the intervention group than the EUC group lost at least 5% of their baseline weight, (70.4% vs. 41.4%, p = 0.035). Retention rates and participant-reported adherence and satisfaction rates were ≥80% in the telenutrition group, thereby meeting the a priori criterion for feasibility of a larger trial. Primary care referred telenutrition interventions have the potential to improve access to dietary counseling for obesity treatment in health disparate populations. A larger longer-term trial is warranted.

Effectiveness of non-medical health worker-led counselling on psychological distress: a randomized controlled trial in rural Nepal.

An essential strategy to increase coverage of psychosocial treatments globally is task shifting to non-medical counsellors, but evidence on its effectiveness is still scarce. This study evaluates the effectiveness of lay psychosocial counselling among persons with psychological distress in a primary health care setting in rural Nepal. A parallel randomized controlled trial in Dang, rural Nepal (NCT03544450). Persons aged 16 and older attending primary care and with a General Health Questionnaire (GHQ-12) score of 6 or more were randomized (1:1) to receive either non-medical psychosocial counselling (PSY) or enhanced usual care (EUC). PSY was provided by lay persons with a 6-month training and consisted of 5-weekly counselling sessions of 35-60 min with a culturally adapted solution-focused approach. EUC was provided by trained primary health workers. Participants were followed up at 1 (T1) and 6 months (T2). The primary outcome, response to treatment, was the reduction of minimum 50% in the Beck Depression Inventory (BDI) score. A total of 141 participants, predominantly socially disadvantaged women, were randomized to receive PSY and 146 to EUC. In the PSY, 123 participants and 134 in the EUC were analysed. In PSY, 101 participants (81.4%) had a response compared with 57 participants (42.5%) in EUC [percentage difference 39.4% (95% CI 28.4-50.4)]. The difference in BDI scores at T2 between PSY and EUC was -7.43 (95% CI -9.71 to -5.14). Non-medical (lay) psychosocial counselling appears effective in reducing depressive symptoms, and its inclusion in mental health care should be considered in low-resource settings.

Effectiveness of a Psychological Intervention Delivered by General Nurses for Alcohol Use Disorders in People Living with HIV in Zimbabwe: A Cluster Randomised Controlled Trial

Background: Limited data exist on the effectiveness of interventions for alcohol use disorders (AUD) in people living with HIV which can be delivered in general health care settings in low- and middle- income countries (LMIC). Methods: Sixteen public health facilities (clusters) were selected nationally through stratified randomisation and then randomised 1: 1 to Motivational Interviewing blended with brief Cognitive Behavioural Therapy (MI-CBT) or to Enhanced Usual Care (EUC). Inclusion criteria for individuals were adults aged 18 years-plus living with HIV who met criteria for AUD defined by Alcohol Use Disorders Identification Test (AUDIT) score of 6 for women and 7 for men. Nurses working in these health facilities were trained to deliver the treatments. Participants in the MI-CBT clusters received 10 sessions. Participants in EUC clusters received 3 sessions of psychoeducation based on the WHO Mental Health Gap Intervention Guide. The primary outcome was change in the AUDIT score at 6 months post-randomization. Secondary outcomes were viral load and functioning, measured by the WHODAS 2.0. A random-effects analysis-of-covariance model was used accounting for the cluster design. Findings: 234 participants were enrolled across 16 clinics, with a mean age of 43.3 years (9.1). 78.6% of the participants were male. 175 (74.8%) were followed up at 6 months. At 6 months follow-up AUDIT score fell by 6.15 (95% CI -6.3; -6.0) points in the MI-CBT arm and by 3.09 (95% CI -3.2; -2.9) points in the EUC arm. The drop in the AUDIT score was significantly greater in the MI-CBT arm compared to EUC: mean difference -2.26 (95% CI -4.53 to -0.01) (p=0.05). The viral load fell and general function improved in both arms with no statistically significant difference between arms. Interpretations: Nurses in government primary care and hospital facilities in low-income countries can be trained to deliver low-cost interventions that can reduce AUDs among PLWH. For people living with HIV, studies with long-term follow-up are needed to show whether longer interventions using Motivational Interviewing-CBT techniques are cost-effective compared to short interventions based on psychoeducation and feedback about alcohol use. Trial Registration: Pan African Clinical Trial Registry, PACTR201509001211149. Funding Statement: Research reported in this publication was supported by the Fogarty International Center (Office of The Director, National Institutes Of Health (OD), National Institute of Nursing Research (NINR), National Institute of Mental Health (NIMH), National Institute of Dental & Craniofacial Research (NIDCR), National Institute of Neurological Disorders and Stroke (NINDS), National Heart, Lung, and Blood Institute (NHLBI), Fogarty International Center (FIC)) of the National Institutes of Health, award D43 TW010137, the DELTAS Africa Initiative [DEL-15-01]. The DELTAS Africa Initiative is an independent funding scheme of the African Academy of Sciences (AAS)’s Alliance for Accelerating Excellence in Science in Africa (AESA) and supported by the New Partnership for Africa’s Development Planning and Coordinating Agency (NEPAD Agency) with funding from the Wellcome Trust [DEL-15-01] and the UK government, Grant Number D43TW010313-02S3 from the National Institutes of Health, Fogarty International Center and the National Research Founding through Funding to Professor Soraya Seedat SARChi Research Chairs. The study also received support from King’s College London Partnership Fund for viral load testing. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Fogarty International Center or the National Institutes of Health, the DELTAS Africa Initiative, King’s College London and the National Research Foundation SARChi Research Chairs. As an FIC scholar, MM also received research training from the Clinical and Translational Science Institute (award UL1TR001412). Declaration of Interests: All authors declare no conflict of interest. Ethics Approval Statement: Stellenbosch Health Research Ethics Committee (HREC) (SI/10/14/222) and the Medical Research Council of Zimbabwe (MRCZ) (A/1936) provided ethics approval.

Randomized trial protocol of bridge intervention for patients with serious mental illness and cancer.

153 Background: Individuals with serious mental illness (SMI) diagnosed with cancer often have disruptions in treatment, leading to premature mortality compared to patients without SMI. To address such gaps in care, we developed and piloted a collaborative care intervention for patients with SMI and cancer (Bridge). We now propose a randomized controlled trial (RCT) to investigate the impact of the Bridge intervention on disruptions in cancer care for patients with SMI. Methods: We will conduct a two-arm RCT (n = 120) comparing Bridge to enhanced usual care (EUC) for patients with SMI (schizophrenia, bipolar disorder, major depressive disorder) and newly diagnosed breast, lung, gastrointestinal, or head/neck cancer. The 12-week Bridge intervention includes: 1) assessment by a psychiatrist with expertise in oncology at cancer diagnosis, 2) involvement of a case manager to promote self-management and care coordination, 3) collaboration between psychiatry and oncology (e.g., joint visits, developing an integrated treatment plan) to address barriers to care, and 4) availability of study clinicians via phone, text, or in-person for consultation and follow-up with patients, caregivers, and oncology and community mental health clinicians. In the EUC arm, study staff will inform the treating oncologist of the psychiatric diagnosis and notify the patient and oncologist of available psychosocial services at enrollment. Patients will be randomized 1:1 to Bridge or EUC, stratified by presence of a caregiver. Identified caregivers will be co-enrolled, and patients without a caregiver will be eligible. We will utilize verbal consent, link study visits to oncology appointments, and personalize frequency and location (e.g., community, clinic, hospital) of contact with patients and caregivers to decrease burden and promote engagement. The primary outcome is the proportion of patients with disruptions in cancer care within 6 months of enrollment, confirmed by oncologists blinded to study arm. Secondary outcomes include clinician assessment of psychiatric illness severity as well as patient and caregiver reported measures (e.g., depression, engagement in care, treatment satisfaction). Results: N/A. Conclusions: N/A. Clinical trial information: NCT03360695.

A Cluster Randomized Controlled Trial of a Stepped-Care Intervention Delivered by Lay Health Workers for Primary Care Patients with Major Depressive Disorder in Nigeria

BACKGROUND: Little is currently known about how to scale up care for depression in settings where non-physician lay workers constitute the bulk of frontline providers. METHODS: Cluster randomized trial conducted in thirty-five primary care clinics in Ibadan, Nigeria (18 intervention arm, 17 control arm). Participants were adults, aged 18 or older, not pregnant, and with moderate to severe depression. The intervention arm received 8 sessions of individual problem-solving therapy, with additional sessions if needed (STEP), plus enhanced usual care (EUC). Control arm received EUC alone. Usual care was enhanced by the use of WHO mhGAP intervention guide. Primary outcome, conducted by blinded assessors, was depression remission at 12 months (score =6 on the 9-item Patient Health Questionnaire). Secondary outcomes were depressive symptoms, disability and quality of life at 6 and 12 months. Service utilization and associated costs were measured. Trial registration number is ISRCTN 46754188. FINDINGS: Participants were 1178 (STEP plus EUC: 631; EUC: 547); 82·8% females. Baseline mean PHQ-9 score was 13·7 (±2·6), 87·9% completed 12-month follow-up (STEP plus EUC: 89%; EUC: 86%). At 12-month, remission from depression was 75·6% in the intervention arm and 77·4% in the control arm [adjusted risk difference -1·8% (95% CI: -6·9, 3·4%), adjusted odds ratio 1·0 (95% CI: 0·70, 1·40)]. At 6 months, the STEP plus EUC group had lower mean depression symptoms than EUC group (3·4 vs. 4·3; adjusted difference in means -0·7 (95% CI -1·3 to -0·2)). No differences in other secondary outcomes were evident. INTERPRETATION: Among primary care patients with moderate to severe depression receiving care from non-physician primary health care workers in Nigeria, STEP plus EUC had similar costs and clinical outcomes as EUC alone. Enhancing usual care with mhGAP-IG may provide simple and affordable approach to scaling up depression care in sub-Saharan Africa. Trial Registration Number: ISRCTN 46754188. Funding: Medical Research Council (MRC) Declaration of Interest: The authors declare that they have no competing interests. Ethical Approval: The Study was approved by the UI/UCH Ethics Committee and its conduct monitored by an independent Trial Steering Committee. All participants provided written (or witnessed, if illiterate) informed consent.