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Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility

NCT04837521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-07-01

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Unified Protocol

Five session psychotherapy

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Andrada Neacsiu, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837521 on ClinicalTrials.gov