Unified Protocol for Older Adults

Adapting the Unified Protocol to Facilitate Activity in Older Adults

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 also develop a self-guided version of this intervention.

This aim will be accomplished in two phases. In Phase 1, patient will receive the UP as written via telehealth. At the end of treatment they will provide feedback on the treatment, including any suggested changes as well as provide 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 version of treatment to see if patients find them acceptable. In this phase, patients will be randomized to receive one of these two treatments.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Anxiety; Emotional Distress
• Intervention / Treatment: Behavioral: Unified Protocol

Detailed Description

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP21) is an optimal intervention to adapt for older adults to increase their engagement in daily activities. The UP is an evidence-based CBT. As a transdiagnostic treatment, it can be applied across diagnostic categories to address a wide range of presenting problems. A systematic literature review, conducted by the Principal Investigator, indicated the UP is efficacious for anxiety, depression, and related emotional problems and has been used with older adults. The UP contains five core skills that are relevant to increasing activity engagement -Session 1 (Motivation & Psychoeducation about Emotions); Session 2 (Breaking down Emotions & Mindfulness); Session 3 (Cognitive Flexibility); Session 4 (Countering Emotion-Driven Behaviors); Session 5 (Exposure and Relapse Prevention).

Transdiagnostic treatments, like the UP, are advantageous with regard to dissemination and implementation because they are adaptable and reduce clinician training burden. The UP has demonstrated adaptability for underserved patient populations and has been successfully abbreviated to meet the needs of unique patient populations. Further, it has been successfully delivered by clinicians without previous CBT experience, increasing its potential for dissemination. A five session version of this treatment (UP-5) was developed that includes the core skills and showed acceptability in adults with acute suicide risk. The primary aim of this study is to adapt the UP-5 for use with older adults reporting emotional distress to increase their daily activity. Because research indicates the proportion of older adults who access and receive evidence-based treatments is low, the study team is proposing to develop therapist-delivered and self-guided versions of the treatment. Self-guided interventions may be ideal for older adults because they do not compete with other healthcare demands and they have potential for significant public health impact for older adults where access to services is low. The secondary aim of this study is to compare the self-guided and therapist-delivered versions to begin identifying the minimum level of intervention needed to increase activity in older adults.

This project is significant because it will produce an implementable, evidence-based treatment to increase access to evidence-based interventions designed to increase daily activity in older adults.

Phase 1. The purpose of Phase 1 is to adapt self-guided and therapist-delivered versions of the UP from the existing UP-5 using stakeholder feedback. The study will use a successive cohort design and deliver the UP-5 to two cohorts of two patients (total of 4). This treatment is a manualized, 5 session cognitive behavioral therapy. Treatment will be provided via telehealth by the interventionist, who has expertise delivering evidence-based psychological treatments to older adults. All sessions will be audio or video recorded in order to be rated for therapist adherence. Patients will be asked for consent to record. Those who do not consent to recording will still be allowed to participate in the study. Participants will be provided with a pedometer to keep track of their step count over the course of treatment and report to their interventionist on a weekly basis. During each treatment session, starting at session 2, the interventionist will complete a Clinical Global Impressions-Improvement (CGI-I) rating and document how much of the homework they think the participant completed since the last session (0-100%). One week after the fifth session, patients will provide feedback about the treatment in exit interviews. Interviews will inquire about topics including modifications needed to develop the self-guided UP-5 (e.g., automatic prompts) and whether/how to include a support person (e.g., caregiver) in treatment. Patients will also complete post-treatment measures at this visit: PSFS, PROMIS-anxiety, PROMIS-depression, CFS, BEAQ, SMQ, and the Credibility and Expectancy of Improvement Scale (CEIS). At the end of Phase 1, a self-guided version of the UP-5 will be developed. After each cohort, the UP-5 will be adapted to reflect the stakeholder feedback and the revised treatment will be delivered the subsequent cohort.

Phase 2. Phase 2 will be a pilot randomized controlled trial comparing the adapted self-guided and therapist-delivered versions of the UP-5. Patients will be randomized to complete one of these two treatments using the randomization module in REDCap. Per established guidelines, each arm will have 8 patients. Therapist-delivered treatment will be provided by telehealth via the study interventionist. All sessions will be audio or video recorded in order to be rated for therapist adherence. Patients will be asked for consent to record. Those who do not consent to recording will still be allowed to participate in the study. Participants will be provided with a pedometer to keep track of their step count over the course of treatment and report to their interventionist on a weekly basis. During each therapist-delivered, treatment session, starting at session 2, the interventionist will complete a Clinical Global Impressions-Improvement (CGI-I) rating and document how much of the homework they think the participant completed since the last session (0-100%). Outcomes will be evaluated pre/post treatment and include measures of daily activity (PSFS), depression (PROMIS-depression), and anxiety (PROMIS-anxiety), CFS, BEAQ, and SMQ. Treatment satisfaction (Client-Satisfaction Questionnaire) will be evaluated post-treatment as well as the Credibility and Expectancy of Improvement Scale (CEIS). The post-treatment visit will be 1 week after completing self-guided or therapist-driven treatment. Five weeks after completing the final treatment session, measures and reporting of daily step count will be collected remotely, one final time. The PI will rate all sessions for therapist adherence.

In regards to the time between the consent visit and the first therapist-delivered therapy session, participants will be allowed to start treatment up to 1month after time of consent, however, on a case by case basis, this window may go longer than 1 month if they maintain contact with the study team and there is a viable reason for the delay. For the 5 sessions of UP-5 treatment, there will be a minimum of 3 days between therapy sessions and all participants will complete the 5 sessions within 2 months (~8 weeks).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrada Neacsiu, PhD; Phone Number: 919-684-6714; Email: andrada.neacsiu@duke.edu
• Study Contact Backup: Name: Lisalynn D Kelley, CCRP; Phone Number: 919-684-6701; Email: lisalynn.kelley@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapist Delivered Unified Protocol; This is a five session psychotherapy designed to help people with problems such as anxiety and depression.	Behavioral: Unified Protocol; Five session psychotherapy
Experimental: Self-Guided Unified Protocol; This is a five session treatment that patients can complete independently.	Behavioral: Unified Protocol; Five session psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Specific Functional Scale (PSFS)	The PSFS is measured on a scale of 0-10 where higher scores indicate higher functioning	Baseline (pre-treatment), 7 weeks (post treatment)
Change in PROMIS-anxiety	The PROMIS-anxiety is measured on a scale of 7-35, with higher scores indicating higher levels of anxiety	Baseline (pre-treatment), 7 weeks (post treatment)
Client Satisfaction Questionnaire (CSQ)	The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction	Post treatment, up to 7 weeks
Change in PROMIS-depression	The PROMIS-depression is measured on a scale of 8-40, with higher scores indicating higher levels of depression	Baseline (pre-treatment), 7 weeks (post treatment)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andrada Neacsiu, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Pro00108029; 5P30AG064201-03 (U.S. NIH Grant/Contract); DBSR-11068 (Other Grant/Funding Number: Duke Roybal Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available on request and in compliance with IRB regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No