ObjectiveTo determine whether, for patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU), we conducted a randomized controlled trial to evaluate the efficacy of a 10-session T-CBT intervention for depression in PD, compared to TAU.MethodsSeventy-two people with PD (PWP) were randomized to T-CBT + TAU or TAU only. T-CBT tailored to PWPs’ unique needs was provided weekly for 3 months, then monthly during 6-month follow-up. CBT targeted negative thoughts (e.g., “I have no control”; “I am helpless”) and behaviors (e.g., social withdrawal, excessive worry). It also trained care partners to help PWP practice healthy habits. Blind raters assessed outcomes at baseline, midtreatment, treatment end, and 1 and 6 months post-treatment. Analyses were intent to treat.ResultsT-CBT outperformed TAU on all depression, anxiety, and quality of life measures. The primary outcome (Hamilton Depression Rating Scale score) improved significantly in T-CBT compared to TAU by treatment end. Mean improvement from baseline was 6.53 points for T-CBT and −0.27 points for TAU (p < 0.0001); gains persisted over 6-month follow-up (p < 0.0001). Improvements were moderated by a reduction in negative thoughts in the T-CBT group only, reflecting treatment target engagement.ConclusionsT-CBT may be an effective depression intervention that addresses a significant unmet PD treatment need and bypasses access barriers to multidisciplinary, evidence-based care.Clinicaltrials.gov identifierNCT02505737.Classification of evidenceThis study provides Class I evidence that for patients with depression and PD, T-CBT significantly alleviated depressive symptoms compared to usual care.

A BS TRACT: Background: For several decades, a myriad of factors have contributed to the inadequate diagnosis and management of depression in Parkinson's disease (PD), leaving up to 60% of significantly symptomatic patients untreated. Poor access to evidencebased neuropsychiatric care is one major barrier to achieving optimal Parkinson's outcomes. Objective: The goal of this study was to compare the efficacy of individual Parkinson's-informed, video-tohome cognitive-behavioral therapy (experimental group), to clinic-based treatment as usual (control group), for depression in PD. Method: Ninety United States military veterans with clinical diagnoses of both depression and PD were computer-randomized (1:1) to either the experimental or control group; randomization was stratified by baseline antidepressant use and blind to all other baseline data.The acute treatment period spanned 10 weeks and was followed by a 6-month extension phase. The Hamilton Depression Rating Scale was the a priori primary outcome. Depression treatment response was defined as a score ≤2 on the Clinical Global Impression Improvement Scale. All statistical analyses were intent to treat. Results: Video-to-home cognitive-behavioral therapy outperformed clinic-based treatment as usual across three separate depression measures (P < 0.001). Effects were observed at the end of acute treatment and maintained through 6-month follow-up. Number needed to treat (based on treatment response classification) was 2.5 with an absolute risk reduction of 40%. Conclusion: Video-to-home cognitive-behavioral therapy may be an effective intervention to bypass access barriers to specialized, evidence-based depression care in PD and to address the unmet neuropsychiatric treatment needs of the Parkinson's community.

This paper describes the rationale and goals of the Patient-Reported Outcome (PRO) Consortium’s instrument translation process. The PRO Consortium has developed a number of novel PRO measures which are in the process of qualification by the U.S. Food and Drug Administration (FDA) for use in clinical trials where endpoints based on these measures would support product labeling claims. Given the importance of FDA qualification of these measures, the PRO Consortium’s Process Subcommittee determined that a detailed linguistic validation (LV) process was necessary to ensure that all translations of Consortium-developed PRO measures are performed using a standardized approach with the rigor required to meet regulatory and pharmaceutical industry expectations, as well as having a clearly defined instrument translation process that the translation industry can support. The consensus process involved gathering information about current best practices from 13 translation companies with expertise in LV, consolidating the findings to generate a proposed process, and obtaining iterative feedback from the translation companies and PRO Consortium member firms on the proposed process in two rounds of review in order to update existing principles of good practice in LV and to provide sufficient detail for the translation process to ensure consistency across PRO Consortium measures, sponsors, and translation companies. The consensus development resulted in a 12-step process that outlines universal and country-specific new translation approaches, as well as country-specific adaptations of existing translations. The PRO Consortium translation process will play an important role in maintaining the validity of the data generated through these measures by ensuring that they are translated by qualified linguists following a standardized and rigorous process that reflects best practice.