Adapting the Unified Protocol to Facilitate Activity in Older Adults
Phase: NA
Conditions: Emotional Distress, Anxiety, Depression
Sponsor: Duke University

Adapting the Unified Protocol to Facilitate Activity in Older Adults 
NCT04837521 
Study Protocol 
Document Date: 1/12/2024 
 
 
 

Older adults experiencing emotional distress also report reduced engagement in daily 
activities. Up to 25% of older adults (age 65+) report symptoms of emotional (e.g., anxiety, 
depressive) disorders which negatively impact their ability to engage in daily activities, and overall 
physical and mental health. Cognitive-behavioral therapies (CBT) are well-established treatments 
for these problems. They can increase engagement in daily activities by teaching patients skills to 
manage the emotional distress that interferes with daily activities. However, the demand for mental 
health services among older adults is rising and existing treatments are insufficient. Existing 
therapies are typically 12-16 sessions, yet data suggest patients attend an average of five 
sessions. Brief treatments are more feasible for older adults to complete. Thus, it is crucial to 
develop brief, evidence-based interventions that can be implemented in community settings for 
older adults experiencing emotional distress to increase their activity. Because it can take 
decades to develop a novel treatment, a strategic approach is to adapt an existing evidence-
based treatment for this population. 
 
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) 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. The UP contains 
five core skills for increasing activity engagement (Table 1).  
Transdiagnostic treatments, like the UP, are advantageous for 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 (Table 1) and showed 
acceptability in adults with acute suicide risk. The primary aim of this study was to adapt the UP-
Table 1. UP-5 Session-by-Session Content  
Session 
Skill Targets 
Relevance to older adults 
1 
Motivation and Psychoeducation 
about Emotions 
Build motivation to increase activity, reduce 
perception that emotions should be avoided. 
2 
Breaking Down Emotions and 
Mindfulness 
Observe and describe emotional experiences, 
mindfulness of activities  
3 
Cognitive Flexibility  
Generate flexible interpretations of situations 
(e.g., ability to be active) 
4 
Countering Emotion-Driven 
Behaviors  
Reduce avoidance of activities  
5 
Exposure and Relapse 
Prevention 
Plan for continued skill use  

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, we propose developing 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 with low access to services. The secondary aim of this study was to compare the 
self-guided and therapist-delivered versions to identify the minimum level of intervention needed 
to increase activity in older adults.  
Recruitment. Patients were recruited from Duke MyChart, ResearchMatch.org, and referrals 
from Duke clinics. 
Screening. Eligibility was determined before consent. Patients interested in completing the study 
were directed to an online screen in REDCap, which provided more information about the 
research and asked potential participants to complete self-report questionnaires. Those meeting 
initial eligibility were contacted for a phone screen (also done as an interview in REDCap). After 
online/phone screen, patients were eligible if they (1) were age 65+, (2) reported moderate or 
higher emotional distress (T-score ≥ 60) on the Patient-Reported Outcomes Measurement 
Information System (PROMIS) emotional distress anxiety OR depression forms, which had been 
used with older adults, (3) reported reduced engagement in instrumental daily activities indicated 
by an average score below “8” on the Patient Specific Functional Scale (PSFS), and (4) were 
willing to engage in telehealth. Patients meeting these criteria by phone screen completion were 
scheduled for a first study visit. 
Consent. Patients completed an electronic consent form in REDCap and pre-treatment 
questionnaires during the first study visit. Participants were deemed eligible based on the 
screening questions they completed on the REDCap online screen & phone screen. Patients also 
completed pre-treatment measures at this consent visit: Demographic Data Survey, PSFS, 
PROMIS-anxiety, PROMIS-depression, PROMIS-Physical Function (PF) and the Credibility and 
Expectancy Questionnaire (CEQ: Devilly & Borkovec, 2000). We also included the Cognitive 
Flexibility Scale (Martin & Rubin, 1995, CFS), Brief Experiential Avoidance Questionnaire 
(Gamez, et.al, 2013, BEAQ), and Southampton Mindfulness Questionnaire (Chadwick, et al., 
2008, SMQ) at intake and the 1-week post-treatment to explore changes from pre- to post-
intervention. Participants who attended this first remote visit were then mailed an Accusplit 
Pedometer to begin using 1 week before their first therapy session, to track the number of daily 
steps. They were emailed an electronic Word document of a weekly table for tracking steps. For 
those in Phase 2, they were mailed the pedometer as well as a measuring tape and electrical 
tape.  
Phase 1. The purpose of Phase 1 was to adapt self-guided and therapist-delivered versions of 
the UP from the existing UP-5 using stakeholder feedback. We also examined physical function 
and physical activity as independent variables that may serve as moderators and as outcomes. 
We used a successive cohort design and delivered the UP-5 to two cohorts of two patients. 
Treatment was provided via telehealth by the Roybal Center interventionist, who has expertise 
delivering evidence-based psychological therapies to older adults. All sessions were audio or 
video recorded to be rated for therapist adherence. Patients were asked for consent to record. 

Those who did not consent to recording were still allowed to participate in the study. During each 
treatment session, participants reported the number of steps they took daily over the past week 
to the study interventionist. Starting at session 2, the interventionist completed a Clinical Global 
Impressions-Improvement (CGI-I) rating and documented how much homework the participant 
completed since the last session (0-100%). After the fifth session, participants were reminded to 
track their number of steps over the next week. One week later, patients provided feedback about 
the treatment in exit interviews. Interviews inquired about 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 as well as treatment preferences and length of treatment. Patients also 
completed post-treatment measures at this 1-week f/u visit: PSFS, PROMIS-anxiety, PROMIS-
depression, PROMIS-PF, CFS, BEAQ, SMQ, and the Credibility and Expectancy of Improvement 
Scale (CEIS). They also provided an electronic form for the interventionist to enter the number of 
steps they had taken over the past week. After each cohort, the UP-5 was adapted to reflect the 
stakeholder feedback, and the revised treatment was delivered to the subsequent cohort. At the 
end of Phase 1 we developed a self-guided version of the UP-5.  
Phase 2. Phase 2 was a pilot randomized controlled trial comparing the adapted self-guided and 
therapist-delivered versions of the UP-5. As in Phase 1, participants completed the PROMIS_PF 
at both intake and post-treatment follow-up to assess physical function. Patients were randomized 
to complete one of these two treatments using the randomization module in REDCap. Each arm 
had eight patients. Therapist-delivered treatment was provided via telehealth.  All sessions were 
audio or video recorded to be rated for therapist adherence. Patients were asked for consent to 
record. Those who did not consent to recording were still allowed to participate in the study.   
Whether randomized to online or therapist-delivered treatment, all participants in Phase 2 
underwent the Virtual Short Physical Performance Battery (SPPB) before the first online or 
therapist treatment session and again at 1 week follow-up after the last session. The Short 
Physical Performance Battery (SPPB) is a performance-based test assessing older adults’ 
mobility by measuring balance, strength, and speed. In this study, we only used the gait speed 
portion. Performance in this category was scored on a scale of 0 to 4. The trained study team 
member performed the gait speed test virtually at intake or the front end of the 1st therapy/online 
session. Participants also reported the number of steps they took daily over the past week before 
their first session. After consenting and before the virtual SPPB, all participants were mailed a 
pedometer and materials to use for the virtual SPPB (measuring tape and black tape) and for 
those participants in the self-guided therapy arm, they received a copy of the self-guided manual 
(uploaded in protocol documents). During each therapist-delivered treatment session, starting at 
session 2, the interventionist completed a Clinical Global Impressions-Improvement (CGI-I) rating. 
It documented how much homework they thought the participant completed since the last session 
(0-100%). Outcomes were evaluated pre/post treatment and included measures of daily activity 
(PSFS), depression (PROMIS-depression), and anxiety (PROMIS-anxiety), CFS, BEAQ, and 
SMQ, and PROMIS-SF. Treatment satisfaction (Client-Satisfaction Questionnaire-8) was 
evaluated post-treatment, the Credibility and Expectancy of Improvement Scale (CEIS) was 
assessed, and a semi-structured exit interview as in Phase 1. The PI provided weekly supervision 
on the therapy sessions and an independent coder rated 10% of completed sessions for 
adherence. Post-Treatment occurred one week after the final therapy or self-guided online 

session, and participants were reminded to track their number of steps in the 1 week after the 
final session. They reported this information to the interventionist/trained study team member at 
the 1-week f/u where they completed the gait speed test virtually one more time & the semi-
structured exit Interview. The rest of the self-report, including the noted outcomes, were also 
completed. 
Participants were allowed to start treatment up to 1 month after the time of consent. For the five 
sessions of UP-5 treatment, there was a minimum of 3 days between therapy sessions and all 
participants completed the five sessions within 2 months (~8 weeks). There was an expected 
short delay from the consent visit to the first therapist-delivered or online platform session to allow 
for the pedometer to arrive at the participant and be able to track steps for the 1 week leading up 
to their first therapy visit. Participants in Phase 1 were in the study approximately 7-12 weeks. In 
phase 2, participants were in the study for approximately 12-17 weeks. 
One month F/u (post the 1 week post-treatment visit- approximately 5 weeks after the final 
online/therapy delivered session): For Phase 2 participants only, to measure effects over a more 
extended period, participants again received the following outcome measures to complete via 
REDCap CFS, CSQ-8, CEIS, BEAQ, and SMQ, (PSFS), depression (PROMIS-depression), and 
anxiety (PROMIS-anxiety and PROMIS-SF. They were sent an email reminder via REDCap to 
begin tracking their steps for 1 week leading up to the 1-month f/u final visit. Participants were 
paid $20 for completing this 1-month f/u. 
Of note, if participants used assisted mobility devices and were enrolled in Phase 1 or 2, they 
could still participate in the study. They were not required to do the gait speed and/or pedometer 
assessment. This was not considered a deviation in the study if not completed.  
Also, if the participant started the virtual SPPB mobility assessment and felt uneasy, 
uncomfortable, unsteady, they were allowed to stop the SPPB at any time and still be allowed to 
continue in the study. If the participant refused to try the SPPB or complete it at the 1-week follow-
up, they were still allowed to be in the study, and again, this was not considered a deviation, but 
it was noted in their REDCap record. 
Remote Self-Guided Therapy Only: An orientation video with instructions and videos for UP 
sessions 1-5 (corresponding to the sessions in the self-guided manual) was posted on the PI's 
Lab YouTube Channel, Duke CHANT, and embedded into REDCap. Comments were disabled on 
YouTube videos, and participants could not "like" the videos or identify themselves or others. Only 
the participants assigned to the self-guided arm were directed to these video links, which were 
not public.  
Study Intervention: The study intervention is a 5-session version of the Unified Protocol for 
Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2018). Below is a brief 
description of the sessions. 
Session 1: Motivation and psychoeducation about the adaptive nature of emotions - focuses on 
setting goals and increasing motivation for treatment, provides psychoeducation about the 
adaptive nature of emotional experiences. In this session the patient and therapist will collaborate 
to set specific, measurable goals for treatment (e.g., go on one walk per day). Next, the patient 

and therapist will discuss the pros/cons of engaging in therapy versus not pursuing treatment. 
This activity facilitates motivation for treatment. Finally, the therapist and patient will discuss the 
reason humans have emotions as well as the purpose of specific emotions such as anxiety and 
sadness.  
Session 2: Learning to observe and describe emotional experiences - teaches mindfulness skills 
and promotes non-judgmental, present-focused awareness of experiences and how to break 
down experiences into three components (thoughts, physical feelings, behaviors). In this session, 
the patient and therapist will discuss the rationale for taking a non-judgmental, present-focused 
approach to experiencing emotions. As part of this discussion, the therapist will teach the patient 
to break down their experiences into thoughts, physical sensations, and behaviors to understand 
their experience in more detail. 
Session 3: Cognitive flexibility - helps develop balanced thoughts through cognitive restructuring 
techniques. The patient and therapist will discuss the reciprocal relationship between thoughts 
and emotions in this session. The therapist will introduce the idea of automatic thoughts and 
thinking traps (i.e., habitual thought patterns that tend to be overly negative) and help the patient 
identify relevant thinking traps. Next, the therapist will introduce the idea of cognitive flexibility and 
work with the patient to develop multiple interpretations of a given situation. This skill is analogous 
to cognitive restructuring in cognitive-behavioral therapy.  
Session 4: Countering emotion-driven behaviors helps patients engage in effective behaviors 
when experiencing strong emotions. In this session, the therapist and patient discuss how 
behavior can influence the experience of emotions. The therapist helps the patient identify 
ineffective behaviors and then presents the idea of alternative actions. Alternative actions are 
behaviors that can help the patient manage their emotions in a way that is consistent with their 
long-term goals. 
Session 5: Exposure and relapse prevention - reduces avoidance of emotion provoking stimuli 
by teaching patients to approach situations they would usually avoid and implement the skills 
learned in treatment in these situations to help them cope, promotes continued practice of skills 
learned in treatment. This session focuses on encouraging patients to approach situations they 
would usually avoid and use their coping skills. The therapist will help the patient brainstorm 
situations to approach and discuss how to use skills. Finally, the therapist and patient will review 
the skills learned in treatment and plan how the patient will continue to practice those skills once 
the treatment is over.