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

Adapting the Unified Protocol to Facilitate Activity in Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04837521
Enrollment
16
Registered
2021-04-08
Start date
2023-04-25
Completion date
2024-05-30
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Emotional Distress

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.

Interventions

BEHAVIORALUnified Protocol

Five session psychotherapy

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 Participants1 Month Post TreatmentRetention of participants through completion of the study

Secondary

MeasureTime frameDescription
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 Score1 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.
Change in PROMIS-depression1 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.
Weekly Stepsat 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
Credibility and Expectancy Scoreone week after treatment, one month after treatmentThe 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 monthsA 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.
Gait SpeedBaseline (1 week before treatment), 1 week post treatmentThe 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.
Change in PROMIS-anxiety1 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.
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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Therapist Delivered Unified Protocol
This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy
8
Self-Guided Unified Protocol
This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
8
Total16

Baseline characteristics

CharacteristicTherapist Delivered Unified ProtocolSelf-Guided Unified ProtocolTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants8 Participants16 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous70.63 years
STANDARD_DEVIATION 5.975
69.5 years
STANDARD_DEVIATION 2.268
70.06 years
STANDARD_DEVIATION 4.404
Brief Experiential Avoidance Questionnaire (BEAQ)48.50 units on a scale
STANDARD_DEVIATION 8.912
52.25 units on a scale
STANDARD_DEVIATION 11.411
50.38 units on a scale
STANDARD_DEVIATION 10.079
Cognitive Flexibility Scale (CFS)56.6250 score on a scale
STANDARD_DEVIATION 7.1101
53.5000 score on a scale
STANDARD_DEVIATION 8.3666
55.0625 score on a scale
STANDARD_DEVIATION 7.6722
Credibility and Expectancy Questionnaire (CEQ)5.7196 score on a scale
STANDARD_DEVIATION 1.1516
6.4218 score on a scale
STANDARD_DEVIATION 0.9424
6.1146 score on a scale
STANDARD_DEVIATION 1.0647
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants8 Participants16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gait Speed (Mean of two trials)4.0494 seconds
STANDARD_DEVIATION 1.4319
3.5794 seconds
STANDARD_DEVIATION 0.946
3.8144 seconds
STANDARD_DEVIATION 1.1972
Patient Specific Functional Scale (PSFS)4.1667 units on a scale
STANDARD_DEVIATION 1.03892
3.4583 units on a scale
STANDARD_DEVIATION 1.0974
3.8124 units on a scale
STANDARD_DEVIATION 1.095
PROMIS Anxiety Total Score23.7500 units on a scale
STANDARD_DEVIATION 2.8661
23.7500 units on a scale
STANDARD_DEVIATION 5.0071
23.7500 units on a scale
STANDARD_DEVIATION 3.9412
PROMIS Depression Total Score24.3750 units on a scale
STANDARD_DEVIATION 7.2961
24.2500 units on a scale
STANDARD_DEVIATION 5.23
24.3125 units on a scale
STANDARD_DEVIATION 6.1179
PROMIS Physical Function Score32.7143 score on a scale
STANDARD_DEVIATION 6.5502
32.8889 score on a scale
STANDARD_DEVIATION 6.0919
32.8125 score on a scale
STANDARD_DEVIATION 6.0797
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants8 Participants14 Participants
Region of Enrollment
United States
8 participants8 participants16 participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
3 Participants2 Participants5 Participants
Weekly Steps3728.1786 steps/week
STANDARD_DEVIATION 1572.4733
4098.9286 steps/week
STANDARD_DEVIATION 2689.656
3913.5536 steps/week
STANDARD_DEVIATION 2136.9491

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 8
other
Total, other adverse events
5 / 80 / 8
serious
Total, serious adverse events
0 / 81 / 8

Outcome results

Primary

Change in Patient Specific Functional Scale (PSFS)

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

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolChange in Patient Specific Functional Scale (PSFS)1 Week Post Treatment3.4167 score on a scaleStandard Deviation 2.1658
Therapist Delivered Unified ProtocolChange in Patient Specific Functional Scale (PSFS)1 Month Post Treatment4.5833 score on a scaleStandard Deviation 1.8148
Self-Guided Unified ProtocolChange in Patient Specific Functional Scale (PSFS)1 Week Post Treatment3.2500 score on a scaleStandard Deviation 1.6011
Self-Guided Unified ProtocolChange in Patient Specific Functional Scale (PSFS)1 Month Post Treatment4.2500 score on a scaleStandard Deviation 1.7067
Comparison: PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.95% CI: [2.32, 4.49]Bayesian framework
Primary

Client Satisfaction Questionnaire (CSQ)

The CSQ is measured on a scale of 8-32, with higher scores indicating higher levels of treatment satisfaction

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolClient Satisfaction Questionnaire (CSQ)1 Week Post treatment30.5 score on a scaleStandard Deviation 0.756
Therapist Delivered Unified ProtocolClient Satisfaction Questionnaire (CSQ)1 Month Post treatment30.88 score on a scaleStandard Deviation 1.642
Self-Guided Unified ProtocolClient Satisfaction Questionnaire (CSQ)1 Week Post treatment23.38 score on a scaleStandard Deviation 4.779
Self-Guided Unified ProtocolClient Satisfaction Questionnaire (CSQ)1 Month Post treatment25.25 score on a scaleStandard Deviation 3.615
p-value: 0.03t-test, 2 sided
Primary

Retention of Participants

Retention of participants through completion of the study

Time frame: 1 Month Post Treatment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Therapist Delivered Unified ProtocolRetention of Participants8 Participants
Self-Guided Unified ProtocolRetention of Participants8 Participants
Secondary

Brief Experiential Avoidance Questionnaire (BEAQ).

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolBrief Experiential Avoidance Questionnaire (BEAQ).1 Week Post-11.8750 units on a scaleStandard Deviation 12.4147
Therapist Delivered Unified ProtocolBrief Experiential Avoidance Questionnaire (BEAQ).1 Month Post-11.2500 units on a scaleStandard Deviation 16.2195
Self-Guided Unified ProtocolBrief Experiential Avoidance Questionnaire (BEAQ).1 Week Post-9.0000 units on a scaleStandard Deviation 9.0396
Self-Guided Unified ProtocolBrief Experiential Avoidance Questionnaire (BEAQ).1 Month Post-8.5000 units on a scaleStandard Deviation 7.01
Secondary

Change in PROMIS-anxiety

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolChange in PROMIS-anxiety1 Week Post Treatment-4.000 score on a scaleStandard Deviation 7.5024
Therapist Delivered Unified ProtocolChange in PROMIS-anxiety1 Month Post Treatment-6.5000 score on a scaleStandard Deviation 6.7612
Self-Guided Unified ProtocolChange in PROMIS-anxiety1 Week Post Treatment-1.1250 score on a scaleStandard Deviation 4.794
Self-Guided Unified ProtocolChange in PROMIS-anxiety1 Month Post Treatment-5.375 score on a scaleStandard Deviation 3.0677
Secondary

Change in PROMIS-depression

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolChange in PROMIS-depression1 Week Post Treatment-4.8750 score on a scaleStandard Deviation 5.8417
Therapist Delivered Unified ProtocolChange in PROMIS-depression1 Month Post Treatment-6.2500 score on a scaleStandard Deviation 5.1478
Self-Guided Unified ProtocolChange in PROMIS-depression1 Week Post Treatment-1.875 score on a scaleStandard Deviation 6.4901
Self-Guided Unified ProtocolChange in PROMIS-depression1 Month Post Treatment-4.625 score on a scaleStandard Deviation 4.5336
Secondary

Cognitive Flexibility Scale (CFS)

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolCognitive Flexibility Scale (CFS)1 Week Post Treatment4.37 score on a scaleStandard Deviation 7.0495
Therapist Delivered Unified ProtocolCognitive Flexibility Scale (CFS)1 Month Post Treatment4.7500 score on a scaleStandard Deviation 5.4182
Self-Guided Unified ProtocolCognitive Flexibility Scale (CFS)1 Week Post Treatment-2.0000 score on a scaleStandard Deviation 10.7836
Self-Guided Unified ProtocolCognitive Flexibility Scale (CFS)1 Month Post Treatment6.8750 score on a scaleStandard Deviation 8.4589
Secondary

Credibility and Expectancy Score

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).

Time frame: one week after treatment, one month after treatment

Population: Mean scores

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolCredibility and Expectancy ScoreOne week after treatment8.3000 units on a scaleStandard Deviation 0.8751
Therapist Delivered Unified ProtocolCredibility and Expectancy ScoreOne month after treatment7.8250 units on a scaleStandard Deviation 1.0222
Self-Guided Unified ProtocolCredibility and Expectancy ScoreOne week after treatment6.550 units on a scaleStandard Deviation 1.457
Self-Guided Unified ProtocolCredibility and Expectancy ScoreOne month after treatment6.775 units on a scaleStandard Deviation 1.317
Secondary

Gait Speed

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.

Time frame: Baseline (1 week before treatment), 1 week post treatment

Population: There were two participants for whom data was not collected due to administrative error at 1 week post treatment.

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolGait Speed1 week before treatment (baseline)4.049 secondsStandard Deviation 1.4319
Therapist Delivered Unified ProtocolGait Speed1 Week Post Treatment3.8983 secondsStandard Deviation 1.139
Self-Guided Unified ProtocolGait Speed1 week before treatment (baseline)3.579 secondsStandard Deviation 0.946
Self-Guided Unified ProtocolGait Speed1 Week Post Treatment3.6650 secondsStandard Deviation 0.9939
Secondary

Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.

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.

Time frame: End of the 5 week-treatment for all participants, approximately 2 months

ArmMeasureValue (NUMBER)
Therapist Delivered Unified ProtocolPercent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.92.3 percent of sessions coded at adherence
Secondary

PROMIS Physical Function Score

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolPROMIS Physical Function Score1 Week Post Treatment2.4286 score on a scaleStandard Deviation 4.4293
Therapist Delivered Unified ProtocolPROMIS Physical Function Score1 Month Post Treatment2.4286 score on a scaleStandard Deviation 4.237
Self-Guided Unified ProtocolPROMIS Physical Function Score1 Week Post Treatment2.3333 score on a scaleStandard Deviation 2.5495
Self-Guided Unified ProtocolPROMIS Physical Function Score1 Month Post Treatment-0.7777 score on a scaleStandard Deviation 4.9441
Secondary

Southampton Mindfulness Questionnaire (SMQ)

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.

Time frame: 1 week (post treatment), 1 month (post treatment)

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolSouthampton Mindfulness Questionnaire (SMQ)1 Week Post Treatment12.2857 score on a scaleStandard Deviation 17.5187
Therapist Delivered Unified ProtocolSouthampton Mindfulness Questionnaire (SMQ)1 Month Post Treatment22.4286 score on a scaleStandard Deviation 10.0155
Self-Guided Unified ProtocolSouthampton Mindfulness Questionnaire (SMQ)1 Week Post Treatment7.1111 score on a scaleStandard Deviation 16.1976
Self-Guided Unified ProtocolSouthampton Mindfulness Questionnaire (SMQ)1 Month Post Treatment14.3125 score on a scaleStandard Deviation 17.1298
Secondary

Weekly Steps

average for each condition of total weekly steps taken by study participants measured on a pedometer

Time frame: 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.

Population: data missing (not submitted) for 2 participants at the 1 month follow up and 1 participant at the 1 week follow up.

ArmMeasureGroupValue (MEAN)Dispersion
Therapist Delivered Unified ProtocolWeekly StepsThe week after treatment26254.7143 stepsStandard Deviation 17190.26649
Therapist Delivered Unified ProtocolWeekly StepsBaseline26097.25 stepsStandard Deviation 11007.31312
Therapist Delivered Unified ProtocolWeekly StepsWeek 1 in treatment24075.25 stepsStandard Deviation 13210.29827
Therapist Delivered Unified ProtocolWeekly StepsWeek 2 in treatment26809.3750 stepsStandard Deviation 14895.31271
Therapist Delivered Unified ProtocolWeekly StepsWeek 3 in treatment30367.875 stepsStandard Deviation 24098.26813
Therapist Delivered Unified ProtocolWeekly StepsWeek 4 in treatment30933.3750 stepsStandard Deviation 20550.41131
Therapist Delivered Unified ProtocolWeekly Stepsthe week following a month after treatment29993.25 stepsStandard Deviation 23367.89734
Self-Guided Unified ProtocolWeekly StepsThe week after treatment40353.6250 stepsStandard Deviation 26573.42281
Self-Guided Unified ProtocolWeekly StepsWeek 3 in treatment43975.50 stepsStandard Deviation 36506.15559
Self-Guided Unified ProtocolWeekly StepsBaseline28692.5 stepsStandard Deviation 18827.59205
Self-Guided Unified ProtocolWeekly Stepsthe week following a month after treatment38454.8333 stepsStandard Deviation 35403.89371
Self-Guided Unified ProtocolWeekly StepsWeek 1 in treatment30716.8750 stepsStandard Deviation 21695.55241
Self-Guided Unified ProtocolWeekly StepsWeek 4 in treatment35602.000 stepsStandard Deviation 24011.11186
Self-Guided Unified ProtocolWeekly StepsWeek 2 in treatment32359.7500 stepsStandard Deviation 20783.19429

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026