A Phase 3 interventional study of Behavioral Based In-Home Intervention in Depression, Stress Reduction and Behavioral Activation Treatment, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2012-08-08.
Sponsored by Thomas Jefferson University · Phase 3 and Interventional
The specific primary aims of the study are to:
A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 192 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will recieve up to 10 1-hour sessions over a 4 month period.
Behavioral: Behavioral Based In-Home Intervention
The 10 session intervention delivered by a social worker in the home includes five treatment components (education, referral, care management, stress reduction, behavioral activation). Each component has been shown to be effective in treating depression in previous research.
Depression
Time frame: Baseline, t2, t3
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University