Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility

Not Applicable

Completed

Conditions: Emotional Distress
Anxiety
Depression

Registration Number: NCT04837521

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	1 week (post treatment), 1 month (post treatment)	The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction
Change in Patient Specific Functional Scale (PSFS)	1 week (post treatment), 1 month (post treatment)	The PSFS is a measure that can be used to quantify activity limitation and adapted to particular individuals and their functional status. Participants can include up to five activities, of which they rate their limitations on a 0-10 scale, where 0 corresponds to unable to perform and 10 corresponds to able to perform at the activity as well as usual. This scale is not specifically designed for between-subjects comparisons of specific activities, but has been validated and shown to be sensitive to changes in musculoskeletal conditions within subjects. The scores represent changes from baseline at the reported follow-up periods
Retention of Participants	1 Month Post Treatment	Retention of participants through completion of the study

Secondary Outcome Measures

Name	Time	Method
Change in PROMIS-depression	1 week (post treatment), 1 month (post treatment)	The PROMIS-depression is measured on a scale of 8-40, with higher scores indicating higher levels of depression. The scores represent changes from baseline at the reported follow up periods.
Brief Experiential Avoidance Questionnaire (BEAQ).	1 week (post treatment), 1 month (post treatment)	The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item self-report measure that assesses an individual's tendency to avoid or escape from unwanted internal experiences, such as uncomfortable emotions, thoughts, memories, or sensations. Higher scores represent more avoidance (range 15- 90). The scores reported here represent changes from baseline at the reported follow up periods.
Weekly Steps	at baseline (i.e., the week before session 1 of treatment), during each of the four remaining therapy weeks (session 1--> session 2; 2--> 3; 3-->4; 4--> 5), the week following treatment, the week following a month after treatment ended.	average for each condition of total weekly steps taken by study participants measured on a pedometer
Change in PROMIS-anxiety	1 week (post treatment), 1 month (post treatment)	The PROMIS-anxiety is measured on a scale of 7-35, with higher scores indicating higher levels of anxiety. The scores represent changes from baseline at the reported follow up periods.
Gait Speed	Baseline (1 week before treatment), 1 week post treatment	The Short Physical Performance Battery (SPPB) is a performance-based assessment designed to evaluate lower extremity function in older adults(Guralnik et al., 1994). The SPPB includes three components, but in this study, we utilized only the gait speed subtest. Performance was measured by a study team member through a virtual session at some point before the first treatment session and once again at the 1-week follow-up visit. Participants were mailed necessary materials, including measuring tape and black tape, to demarcate a length of three meters. Participants were instructed to walk this distance at their ordinary pace while the time was recorded to calculate their gait speed. Mean gait speed across two trials was calculated at each assessment.
Cognitive Flexibility Scale (CFS)	1 week (post treatment), 1 month (post treatment)	The Cognitive Flexibility Scale (CFS) measures one's ability to adapt in response to changes in environments and situations, on a range from 1 to 72. Higher scores on the CFS indicate greater cognitive flexibility. The scores represent changes from baseline at the reported follow-up periods. Therefore, a positive score represents an increase in cognitive flexibility from baseline.
Southampton Mindfulness Questionnaire (SMQ)	1 week (post treatment), 1 month (post treatment)	The SMQ ranges from 0 to 96, with higher scores indicating more mindfulness. The scores represent changes from baseline at the reported follow-up periods.
PROMIS Physical Function Score	1 week (post treatment), 1 month (post treatment)	The PROMIS Physical Function Scale is an 8-item self-report examining difficulty with engaging in daily activities. Items are rated on a scale of 1-5 (unable to do -- can do without any difficulty), with lower scores representing more impairment in functioning. The scale ranges from 8 to 40. Here we present changes from baseline.
Credibility and Expectancy Score	one week after treatment, one month after treatment	The CEQ (Devilly \& Borkovec, 2000) is a six-item scale intended to measure patients' perceptions of a treatment's logicality and potential success with good evidence for validity and reliability. At intake, we administered a 6-item adaptation, assessing how logical the UP protocol sounded before being administered and expectations about how effective the treatment would be in reducing distress. We then administered a 5-item adapted version of this questionnaire at one-week and one-month follow-up visits. Participants rated each item on a scale from 1 to 9 ("not at all" - "very"). Items included how logical they perceived the treatment to be, how confident they were in successfully using the strategies presented and recommending it to a friend, and how successful they thought the treatment was at improving emotional well-being and activity levels. A summary score is computed by averaging the answers, with higher scores indicating more credibility of the intervention (range 1-9).
Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.	End of the 5 week-treatment for all participants, approximately 2 months	A rater trained by the PI scored 35% of therapist-driven sessions. Each session was rated using yes/no answers for 12 different domains . An overall computed score captured how many domains were coded as yes in the particular session. The session duration needed to be at least 30 minutes for the session to be considered adherent. In addition, each session was rated for adequacy using 5 items that assessed the therapist's level of engagement and ability to manage the session on a 0-5 scale("Poor" to "Excellent"). These items were averaged. We computed a binary yes/no score that captured whether the session adhered to the protocol. To be adherent, a session needed to include at least 10/12 elements and have an average adequacy rating of at least 3/5. Adherence was not measured in the self-help group because the therapist did not deliver any direct intervention in this group. We present the percentage of sessions coded as adherent from a random selection of videotaped sessions.

Trial Locations

Locations (1): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States