IMPORTANCE There is little evidence to guide management of depressive symptoms in older people. OBJECTIVE To evaluate whether a collaborative care intervention can reduce depressive symptoms and prevent more severe depression in older people. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted from May 24, 2011, to November 14, 2014, in 32 primary care centers in the United Kingdom among 705 participants aged 65 years or older with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) subthreshold depression; participants were followed up for 12 months. INTERVENTIONS Collaborative care (n=344) was coordinated by a case manager who assessed functional impairments relating to mood symptoms. Participants were offered behavioral activation and completed an average of 6 weekly sessions. The control group received usual primary care (n=361). MAIN OUTCOMES AND MEASURES The primary outcome was self-reported depression severity at 4-month follow-up on the 9-item Patient Health Questionnaire (PHQ-9; score range, 0-27). Included among 10 prespecified secondary outcomes were the PHQ-9 score at 12-month follow-up and the proportion meeting criteria for depressive disorder (PHQ-9 score Ն10) at 4-and 12-month follow-up. RESULTS The 705 participants were 58% female with a mean age of 77 (SD, 7.1) years. Four-month retention was 83%, with higher loss to follow-up in collaborative care (82/344 [24%]) vs usual care (37/361 [10%]). Collaborative care resulted in lower PHQ-9 scores vs usual care at 4-month follow-up. The proportions of participants meeting criteria for depression at 4-month follow-up were 17.2% (45/262) vs 23.5% (76/324), respectively (difference, −6.3% [95% CI, −12.8% to 0.2%]; relative risk, 0.83 [95% CI, 0.61-1.27]; P = .25) and at 12-month follow-up were 15.7% (37/235) vs 27.8% (79/284) (difference, −12.1% [95% CI, −19.1% to −5.1%]; relative risk, 0.65 [95% CI, 0.46-0.91]; P = .01). Collaborative Care Usual Care Difference (95% CI) P Value PHQ-9 score, mean At 4 mo (primary outcome) 5.36 6.67 −1.31 (−1.95 to −0.67) <.001 At 12 mo 5.93 7.25 −1.33 (−2.10 to −0.55) .001 CONCLUSIONS AND RELEVANCE Among older adults with subthreshold depression, collaborative care compared with usual care resulted in a statistically significant difference in depressive symptoms at 4-month follow-up, of uncertain clinical importance. Although differences persisted through 12 months, findings are limited by attrition, and further research is needed to assess longer-term efficacy.

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Accessible Summary• The NHS Constitution states that all patients should have opportunity to take part in approved research • This study asked clinical researchers how they include people with intellectual disabilities and/or autism in research • Many barriers were identified that relate to making mental capacity judgements • Many researchers agreed new resources that support consent and capacity judgements for research would be helpful and gave some ideas about what could help. AbstractBackground: Adults with intellectual disabilities and/or autism are often excluded from participating in health and healthcare research. Understanding study information, which is an important aspect of demonstrating capacity to give informed consent, can be a particular challenge. This study surveyed clinical researchers to discover: (i) their experiences of assessing mental capacity for research; (ii) what methods they used to facilitate the inclusion of adults with intellectual disabilities and/or autism; and (iii) their views about a proposal to develop new resources to facilitate mental capacity judgements with adults with intellectual disabilities and/or autism for informed consent for research. Methods: Clinical researchers in North East England who conduct research with NHSpatients with intellectual disabilities and/or autism were invited to participate in a 22item self-completed semi-structured questionnaire survey, either online or on paper.Results: Twenty-one clinicians completed the survey (response rate 30.4%).Participants reported on 18 research studies which included people with intellectual disabilities and/or autism. In many studies people who lacked capacity to give informed consent were excluded, and often shortcuts were taken in judging capacity.Limited adaptations to support capacity were used. Respondents welcomed the proposal of developing assistive resources that could support capacity judgements and informed consent to research. Conclusions:To improve access to research for people with intellectual disabilities and/or autism, researchers need robust methods to facilitate informed consent and | 231 HAMILTON eT AL.