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

NCT04837521 | Completed Results

• 3 other identifiers: Pro001080295P30AG064201-03DBSR-11068
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Emotional Distress; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• Client Satisfaction Questionnaire (CSQ)

  The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction

  1 week (post treatment), 1 month (post treatment)

• Change in Patient Specific Functional Scale (PSFS)

  The PSFS is a measure that can be used to quantify activity limitation and adapted to particular individuals and their functional status. Participants can include up to five activities, of which they rate their limitations on a 0-10 scale, where 0 corresponds to unable to perform and 10 corresponds to able to perform at the activity as well as usual. This scale is not specifically designed for between-subjects comparisons of specific activities, but has been validated and shown to be sensitive to changes in musculoskeletal conditions within subjects. The scores represent changes from baseline at the reported follow-up periods

  1 week (post treatment), 1 month (post treatment)

• Retention of Participants

  Retention of participants through completion of the study

  1 Month Post Treatment

Secondary Outcomes (10)

• Change in PROMIS-depression

  1 week (post treatment), 1 month (post treatment)

• Change in PROMIS-anxiety

  1 week (post treatment), 1 month (post treatment)

• Brief Experiential Avoidance Questionnaire (BEAQ).

  1 week (post treatment), 1 month (post treatment)

• Cognitive Flexibility Scale (CFS)

  1 week (post treatment), 1 month (post treatment)

• Southampton Mindfulness Questionnaire (SMQ)

  1 week (post treatment), 1 month (post treatment)

Study Arms (2)

Therapist Delivered Unified Protocol

EXPERIMENTAL

This is a five session psychotherapy designed to help people with problems such as anxiety and depression.

Behavioral: Unified Protocol

Self-Guided Unified Protocol

EXPERIMENTAL

This is a five session treatment that patients can complete independently.

Behavioral: Unified Protocol

Interventions

Unified Protocol BEHAVIORAL

Five session psychotherapy

Self-Guided Unified Protocol; Therapist Delivered Unified Protocol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• are age 65+
• report moderate or higher emotional distress
• report reduced engagement in daily activities
• are willing to engage in telehealth.

You may not qualify if:

• present with conditions requiring immediate prioritization (e.g., suicide attempt within past 6months, suicidal ideation with intent/plan, diagnosed with mania/bipolar I, psychosis)
• are currently receiving psychotherapy
• have been diagnosed with dementia or has significant concerns with memory as per online/phone screener
• have changed their psychiatric medications in the past six weeks
• cannot read
• are blind
• cannot speak English

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Andrada Neacsiu
• Organization: Duke University

andrada.neacsiu@duke.edu

+1 919 684 6714

Study Officials

• Andrada Neacsiu, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 is Single Group. However, Phase 2 is a parallel comparison of self-guided with therapist-delivered versions of the UP-5

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: April 25, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 1, 2025
• Results First Posted: June 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)