Clinical trial NCT04837521: Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility
Official title: Adapting the Unified Protocol to Facilitate Activity in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Anxiety
Depression
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1 is Single Group. However, Phase 2 is a parallel comparison of self-guided with therapist-delivered versions of the UP-5
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 a type of cognitive behavioral therapy (CBT) with evidence base to reduce psychopathology, especially in transdiagnostic anxiety. As a transdiagnostic treatment, it can be applied across diagnostic categories to address a wide range of presenting problems. 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 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 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 the 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 was to adapt self-guided and therapist-delivered versions of the UP from the existing UP-5 using stakeholder feedback. The study used a successive cohort design and delivered the UP-5 to two cohorts of two patients (total of 4). One week after the fifth session, patients provided feedback about the treatment in exit interviews, which was used to develop and refine 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. Patients were randomized to complete one of these two treatments, 8 patients in each treatment arm. Therapist-delivered treatment was provided by telehealth via the study interventionist. All sessions were audio or video recorded so that a percentage could be rated for therapist adherence. Participants were provided with a pedometer to keep track of their step count throughout treatment. During each therapist-delivered treatment session, starting at session 2, the interventionist completed a Clinical Global Impressions-Improvement (CGI-I) rating and documented how much of the homework they thought the participant completed since the last session (0-100%). Outcomes were evaluated pre/post treatment and include measures of daily activity (PSFS), depression (PROMIS-depression), anxiety (PROMIS-anxiety), cognitive flexibility, experiential avoidance (BEAQ), and mindfulness (SMQ). Treatment satisfaction (Client-Satisfaction Questionnaire) and credibility and expectancy of improvement (CEIS) were evaluated post-treatment. The post-treatment visit was 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 were collected remotely, one final time.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Change in Patient Specific Functional Scale (PSFS)
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Retention of Participants
timeFrame: 1 Month Post Treatment
Secondary outcomes:
measure: Change in PROMIS-depression
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Change in PROMIS-anxiety
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Brief Experiential Avoidance Questionnaire (BEAQ).
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Cognitive Flexibility Scale (CFS)
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Southampton Mindfulness Questionnaire (SMQ)
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: PROMIS Physical Function Score
timeFrame: 1 week (post treatment), 1 month (post treatment)
measure: Gait Speed
timeFrame: Baseline (1 week before treatment), 1 week post treatment
measure: Weekly Steps
timeFrame: at baseline (i.e., the week before treatment), during each of the five therapy weeks, the week following treatment, the week following a month after treatment ended.
measure: Credibility and Expectancy Score
timeFrame: one week after treatment, one month after treatment
measure: Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.
timeFrame: End of the 5 week-treatment for all participants, approximately 2 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrada Neacsiu, PhD
role: PRINCIPAL_INVESTIGATOR
References: