Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT04837521
- Status
- Completed
Conditions
- Anxiety
- Depression
- Emotional Distress
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Unified Protocol — BEHAVIORALFive session psychotherapy
Study Details
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.
Key Dates
- Start date
- Apr 25, 2023
- Status verified
- May 2024
- Primary completion
- May 30, 2024
- Completion
- May 30, 2024
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Therapist Delivered Unified ProtocolThis is a five session psychotherapy designed to help people with problems such as anxiety and depression.
- Experimental: Self-Guided Unified ProtocolThis is a five session treatment that patients can complete independently.
Primary Outcome Measure
Client Satisfaction Questionnaire (CSQ) [ Time Frame: 1 week (post treatment), 1 month (post treatment) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | - |
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