Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04837521 |
| Other study ID # |
Pro00108029 |
| Secondary ID |
5P30AG064201-03D |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 25, 2023 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
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).
