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NCT04837521 · ClinicalTrials.gov registry record · NA
Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT04837521: Completed NA study, sponsored by Duke University.
NCT04837521 is a NA study that has completed, run by Duke University. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04837521, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity. The overarching goal of this proposal is to adapt an existing evidence-based intervention, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), to increase activity in older adults by reducing emotional distress. The primary aim of the proposed study is to adapt a 5-session version of the UP for use with older adults reporting emotional distress and reduced engagement in daily activities and to develop a self-guided version of this intervention. This aim will be accomplished in two phases. In Phase 1, patients will receive a short 5-session version of the UP via telehealth. At the end of treatment, they will provide feedback on the treatment, including any suggested changes, as well as suggestions for changing the treatment that might allow an individual to successfully complete it on their own. This information will be used to iteratively change the treatment and develop a self-guided version of the treatment. In Phase 2, the study team will compare the therapist-delivered and self-guided versions of treatment to see if patients find them acceptable. In this phase, patients will be randomized to receive one of these two treatments.
Primary Outcome
The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction
Interventions
- BEHAVIORAL Unified Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-04-25 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
What the finished NCT04837521 record still lists
NCT04837521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Unified Protocol is the first listed.
NCT04837521 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04837521 about?
NCT04837521 is a clinical study titled "Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility". Research suggests older adults report wide-ranging emotional distress (e.g., symptoms of anxiety, depression) that negatively impacts their physical and mental health and is associated with a reduction in daily activity. The overarching goal of this proposal is to adapt an existing evidence-based in...
What is the current status of trial NCT04837521?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2023-04-25. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT04837521?
The interventions under investigation include: Unified Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT04837521?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04837521's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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