Improving function in Age-Related Macular Degeneration: design and methods of a randomized clinical trial.

Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD\u27s prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population

Personality and functional vision in older adults with age-related macular degeneration

Introduction: The purpose of the study was to determine whether personality traits influence self-reported functional vision in patients with age-related macular degeneration (AMD). Methods: This is a prospective cross-sectional analysis of baseline data from the Low Vision Depression Prevention Trial. Participants (N = 182) over age 65 with bilateral AMD, visual acuity worse than 20/70 in the better-seeing eye, and subthreshold depression were recruited from the Wills Eye Hospital retina practice. Assessments included visual acuity, contrast sensitivity, National Eye Institute Visual Function Questionnaire-25 plus Supplement (NEI VFQ-25) near and distance subscales, depression, and personality testing. Structural equation models were used to investigate the relationship of the NEI VFQ near activities and distance activities with the various demographic, clinical, and psychological predictors. Results: In the single-predictor model for near functional vision, visual acuity at logMAR ≤ 1 (estimate = -0.33 [95% confidence interval {CI} -0.46, -0.20]; p ≤ 0.001), neuroticism (estimate = -0.05 [95% CI -0.08, -0.01]; p = 0.01), and education (estimate = -0.08 [95% CI 0.01, 0.15]; p = 0.03) were statistically significant predictors. In the single-predictor model for distance functional vision, only visual acuity at logMAR ≤ 1 (estimate = -0.49 [95% CI -0.69, -0.29]; p ≤ 0.001) and neuroticism (estimate = -0.09 [95% CI -0.15, 0.02]; p = 0.008) were statistically significant predictors. Discussion: Self-reported functional vision depends on the severity of vision loss as well as the personality trait of neuroticism. Implications for practitioners: Assessment of personality traits, particularly neuroticism, may increase the precision of rating scales of functional vision and suggest new rehabilitative interventions to improve the functional vision and quality of life of patients with AMD © 2014 AFB, All Rights Reserved

Improving Function in Age-related Macular Degeneration: A Randomized Clinical Trial.

PURPOSE: To compare the efficacy of problem-solving therapy (PST) with supportive therapy (ST) to improve targeted vision function (TVF) in age-related macular degeneration (AMD). DESIGN: Single-masked, attention-controlled, randomized clinical trial with outcome assessments at 3 months (main trial endpoint) and 6 months (maintenance effects). PARTICIPANTS: Patients with AMD (n = 241) attending retina practices. INTERVENTIONS: Whereas PST uses a structured problem-solving approach to reduce vision-related task difficulty, ST is a standardized attention-control treatment. MAIN OUTCOME MEASURES: We assessed TVF, the 25-item National Eye Institute Vision Function Questionnaire plus Supplement (NEI VFQ), the Activities Inventory (AI), and vision-related quality of life (QoL). RESULTS: There were no between-group differences in TVF scores at 3 (P = 0.47) or 6 (P = 0.62) months. For PST subjects, mean ± standard deviation TVF scores improved from 2.71±0.52 at baseline to 2.18±0.88 at 3 months (P = 0.001) and were 2.18±0.95 at 6 months (change from 3 to 6 months, P = 0.74). For ST subjects, TVF scores improved from 2.73±0.52 at baseline to 2.14±0.96 at 3 months (P = 0.001) and were 2.15±0.96 at 6 months (change from 3 to 6 months, P = 0.85). Similar proportions of PST and ST subjects had less difficulty performing a TVF goal at 3 months (77.4% vs 78.6%, respectively; P = 0.83) and 6 months (76.2% vs 79.1%, respectively; P = 0.61). There were no changes in the NEI VFQ or AI. Vision-related QoL improved for PST relative to ST subjects at 3 months (F(4, 192) = 2.46; P = 0.05) and at 6 months (F(4, 178) = 2.55; P = 0.05). The PST subjects also developed more adaptive coping strategies than ST subjects. CONCLUSIONS: We found that PST was not superior to ST at improving vision function in patients with AMD, but that PST improved their vision-related QoL. Despite the benefits of anti-vascular endothelial growth factor treatments, AMD remains associated with disability, depression, and diminished QoL. This clinical reality necessitates new rehabilitative interventions to improve the vision function and QoL of older persons with AMD. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article

Low Vision Depression Prevention Trial in Age-Related Macular Degeneration: A Randomized Clinical Trial.

PURPOSE: To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). DESIGN: Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. PARTICIPANTS: Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). INTERVENTIONS: Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. MAIN OUTCOME MEASURES: The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). RESULTS: At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. CONCLUSIONS: An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry, rehabilitation, psychiatry, and behavioral psychology may prevent depression in this population

Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision

Purpose: The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient\u27s physician, with a waiting-list control group in people with sight loss and depressive symptoms. Methods: This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person\u27s physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.\u27s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. Results: At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. Conclusions: Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large

The depression in visual impairment trial (DEPVIT): trial design and protocol

<b>Background</b> The prevalence of depression in people with a visual disability is high but screening for depression and referral for treatment is not yet an integral part of visual rehabilitation service provision. One reason for this may be that there is no good evidence about the effectiveness of treatments in this patient group. This study is the first to evaluate the effect of depression treatments on people with a visual impairment and co morbid depression.<p></p> <b>Methods/design</b> The study is an exploratory, multicentre, individually randomised waiting list controlled trial. Participants will be randomised to receive Problem Solving Therapy (PST), a ‘referral to the GP’ requesting treatment according to the NICE’s ‘stepped care’ recommendations or the waiting list arm of the trial. The primary outcome measure is change (from randomisation) in depressive symptoms as measured by the Beck’s Depression Inventory (BDI-II) at 6 months. Secondary outcomes include change in depressive symptoms at 3 months, change in visual function as measured with the near vision subscale of the VFQ-48 and 7 item NEI-VFQ at 3 and 6 months, change in generic health related quality of life (EQ5D), the costs associated with PST, estimates of incremental cost effectiveness, and recruitment rate estimation.<p></p> <b>Discussion</b> Depression is prevalent in people with disabling visual impairment. This exploratory study will establish depression screening and referral for treatment in visual rehabilitation clinics in the UK. It will be the first to explore the efficacy of PST and the effectiveness of NICE’s ‘stepped care’ approach to the treatment of depression in people with a visual impairment.<p></p&gt

A Video-Delivered Family Therapeutic Intervention for Perinatal Women With Clinically Significant Depressive Symptoms and Family Conflict: Indicators of Feasibility and Acceptability

BackgroundVariation in family therapeutic intervention fidelity has an impact on outcomes. The use of video conferencing technology can strengthen therapist fidelity to family therapeutic interventions. ObjectiveThis article explores indicators of feasibility and acceptability for a video-delivered family therapeutic intervention for perinatal women with depressive symptoms and family conflict. The objectives of this article are to describe indicators of feasibility, including therapist fidelity to the intervention and technological factors that relate to implementation of the intervention, as well as indicators of acceptability for participants of the intervention. MethodsThe data included in this article are from an ongoing randomized trial of the Resilience Enhancement Skills Training (REST) video-delivered family therapeutic intervention. Participant recruitment and data collection are still underway for this clinical trial. Of the 106 participants who are currently enrolled in this study, 54 (51%) have been randomized to receive REST from May 2021 through July 2022. Currently, 2 therapists are delivering the intervention, and the training procedures for therapists are summarized herein. Therapist fidelity to the family therapeutic intervention was assessed in 67 audio recorded sessions. The training procedures were summarized for use of video conferencing technology by therapists and the 54 study participants. Knowledge of the video conferencing technology features was assessed in therapists and study participants by the number of attempts required to use the features. Participant responsiveness to the intervention was assessed by the percentage of attended sessions and percentage of complete homework assignments. ResultsTo date, both therapists have demonstrated high fidelity to the family therapeutic intervention and used all video conferencing technology features on their first attempt. The current participants required 1 to 3 attempts to use 1 or more of the video conferencing technology features. About 59% (n=32) of the current participants immediately accessed the features on the first attempt. Our results show that perinatal women attended all sessions, and their family members attended 80% of the sessions. To date, participants have completed 80% of the homework assignments. ConclusionsThese early findings describe indicators of the feasibility and acceptability of the video-delivered family therapeutic intervention for use with this high priority population. Upon completion of recruitment and data collection, a subsequent article will include a mixed methods process evaluation of the feasibility and acceptability of the video-delivered family therapeutic intervention. Trial RegistrationClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT0474177