N/A
N=16
Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
Emotional Distress · Anxiety · Depression
Bottom Line
View on ClinicalTrials.gov: NCT04837521 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Jun 2025
Primary outcome: Primary: Client Satisfaction Questionnaire (CSQ) — 30.5; 23.38; 30.88; 25.25 score on a scale — p=.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Unified Protocol (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Satisfaction Questionnaire (CSQ) |
30.5; 23.38; 30.88; 25.25 | .03 sig |
| PRIMARY Change in Patient Specific Functional Scale (PSFS) |
3.4167; 3.2500; 4.5833; 4.2500 | — |
| PRIMARY Retention of Participants |
8; 8 | — |
| SECONDARY Change in PROMIS-depression |
-4.8750; -1.875; -6.2500; -4.625 | — |
| SECONDARY Change in PROMIS-anxiety |
-4.000; -1.1250; -6.5000; -5.375 | — |
| SECONDARY Brief Experiential Avoidance Questionnaire (BEAQ). |
-11.8750; -9.0000; -11.2500; -8.5000 | — |
| SECONDARY Cognitive Flexibility Scale (CFS) |
4.37; -2.0000; 4.7500; 6.8750 | — |
| SECONDARY Southampton Mindfulness Questionnaire (SMQ) |
12.2857; 7.1111; 22.4286; 14.3125 | — |
| SECONDARY PROMIS Physical Function Score |
2.4286; 2.3333; 2.4286; -0.7777 | — |
| SECONDARY Gait Speed |
4.049; 3.579; 3.8983; 3.6650 | — |
| SECONDARY Weekly Steps |
26097.25; 28692.5; 24075.25; 30716.8750; 26809.3750; 32359.7500 | — |
| SECONDARY Credibility and Expectancy Score |
8.3000; 6.550; 7.8250; 6.775 | — |
| SECONDARY Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study. |
92.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- are age 65+
- report moderate or higher emotional distress
- report reduced engagement in daily activities
- are willing to engage in telehealth.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04837521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.