Trial results for a study investigating the Unified Protocol for older adults with emotional distress and reduced mobility were posted on ClinicalTrials.gov on 2025-06-10, with 16 participants enrolled.
Background
Older adults frequently report emotional distress, including symptoms of anxiety and depression, which can negatively affect their physical and mental health and lead to reduced daily activity. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an existing evidence-based intervention. This study aimed to adapt a 5-session version of the UP to help older adults increase activity by reducing emotional distress.
Trial design
This completed study, designated as Phase NA, enrolled 16 participants to investigate conditions including Emotional Distress, Anxiety, and Depression. The trial adapted a 5-session version of the Unified Protocol for use with older adults. Participants were assigned to either a Therapist Delivered Unified Protocol group or a Self-Guided Unified Protocol group.
Key results
The trial reported several key measurements and analyses:
- Client Satisfaction Questionnaire (CSQ) scores (on a scale):
- For the Therapist Delivered Unified Protocol group, mean scores were 30.5 (Standard Deviation 0.756) and 30.88 (Standard Deviation 1.642).
- For the Self-Guided Unified Protocol group, mean scores were 23.38 (Standard Deviation 4.779) and 25.25 (Standard Deviation 3.615).
- Change in Patient Specific Functional Scale (PSFS) scores (on a scale):
- For the Therapist Delivered Unified Protocol group, mean changes were 3.4167 (Standard Deviation 2.1658) and 4.5833 (Standard Deviation 1.8148).
- For the Self-Guided Unified Protocol group, mean changes were 3.2500 (Standard Deviation 1.6011) and 4.2500 (Standard Deviation 1.7067).
- Retention of Participants: Both the Therapist Delivered Unified Protocol group and the Self-Guided Unified Protocol group retained 8 participants each.
- Change in PROMIS-depression scores (on a scale):
- For the Therapist Delivered Unified Protocol group, the mean change was -4.8750 (Standard Deviation 5.8417).
- For the Self-Guided Unified Protocol group, the mean change was -1.875 (Standard Deviation 6.4901).
Key analyses included:
- A t-test, 2 sided, reported a p-value of 0.03 for a γ01 parameter value of 0.25.
- Analysis of PSFS scores using mixed-effects linear growth models within a Bayesian framework showed a Mean Difference (Final Values) of 3.4, with a 95.0% confidence interval ranging from 2.32 to 4.49.
What this means
The posted results suggest that both therapist-delivered and self-guided versions of the Unified Protocol were associated with improvements in client satisfaction and functional abilities among older adults experiencing emotional distress and reduced mobility. Specifically, the Bayesian analysis indicated a positive mean difference of 3.4 in Patient Specific Functional Scale (PSFS) scores. While the therapist-delivered group showed a larger mean reduction in PROMIS-depression scores, both approaches demonstrated changes in depressive symptoms. These findings contribute to understanding potential benefits of adapted Unified Protocol interventions for this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility" were posted on 2025-06-10 on clinicaltrials.gov.