This resubmission application is in response to PAR-06-248: From Intervention Development to Services: Exploratory Research Grants (R34). While there is extensive evidence for the effectiveness of Problem Solving Treatment for Primary Care (PST-PC) in major depression and some suggesting its potential for minor depression, there has been no work examining the feasibility of integrating PST into community-based rehabilitation settings for older adults, nor addressing treatment effects on rehabilitation outcomes in addition to depression. Yet, disabled older patients in rehabilitation settings are of particular interest given the well documented, robust relationship between depression and disability and evidence of the high prevalence of sub-threshold depression among disabled elders and its negative consequences for rehab outcomes. Thus, the goal of this R34 application is to evaluate the feasibility and tolerability of PST with visually disabled elders to treat subthreshold depression within the context of community-based rehabilitation, to determine if ? modifications to the treatment manual are indicated, and to obtain the preliminary data needed to inform the development of a large-scale, multi-site clinical trial.
Specific aims are: (1) to demonstrate PST implementation fidelity including recruitment, acceptance, and adherence to the protocol; (2) to identify the potential of PST for older visually impaired adults with subthreshold depression relative to: (a) primary outcomes of depression remission and clinically significant reductions in depressive symptoms, (b) secondary outcomes of rehabilitation service utilization and improvement of functional ability, and (c) to explore whether problem solving skills and self-efficacy mediate the effect of PST on depression and secondary outcomes; and (3) Based on results from Aims 1&2, to further refine study procedures and measures and establish parameters (e.g., estimates of effect size, attrition rates) necessary for the design of a larger scale clinical trial. Sixty participants (age 60+) with subthreshold depression (minor depression and/or Hamilton Depression Rating Scale score of 10 or greater) will be randomized to treatment (6 1-hour PST sessions and usual care rehab) and comparison groups (usual care rehab with social contact). Assessments will be conducted at baseline, 11 weeks (post-treatment) and 3 months post treatment. Analyses will utilize hierarchical linear and nonlinear modeling (multilevel modeling) to examine group differences, changes in primary and secondary outcomes, and mediating effects. Particular attention will be given to developing estimates of effect size for the design of a large clinical trial. Treatment fidelity will be assessed, including evaluation of the recruitment process, provider training, treatment delivery and receipt, and enactment of treatment skills, in order to identify issues that would need to be addressed prior to the design of a larger trial. While the proposed study targets visually impaired elders in rehabilitation, findings will also inform the broader field of geriatric rehabilitation, where rates of untreated depression are high across disabilities. ? ? ?
| Le Grange, Daniel; Lock, James; Agras, W Stewart et al. (2015) Randomized Clinical Trial of Family-Based Treatment and Cognitive-Behavioral Therapy for Adolescent Bulimia Nervosa. J Am Acad Child Adolesc Psychiatry 54:886-94.e2 |
