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

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Unified Protocol — BEHAVIORAL
    Five 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 Protocol
    This is a five session psychotherapy designed to help people with problems such as anxiety and depression.
  • Experimental: Self-Guided Unified Protocol
    This 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)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

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