Unified Protocol for Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Adapting the Unified Protocol to Facilitate Activity in Older Adults

Conditions
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Emotional Distress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Unified Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are age 65+ report moderate or higher emotional distress report reduced engagement in daily activities are willing to engage in telehealth. Exclusion Criteria: present with conditions requiring immediate prioritization (e.g., suicide attempt within past 6months, suicidal ideation with intent/plan, diagnosed with mania/bipolar I, psychosis) are currently receiving psychotherapy have been diagnosed with dementia or has significant concerns with memory as per online/phone screener have changed their psychiatric medications in the past six weeks cannot read are blind cannot speak English

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 1 is Single Group. However Phase 2 is parallel comparison to self-guided and therapist-delivered versions of the UP-5
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 
| 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) | 
| 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 |