Trial Outcomes & Findings for Five Session Unified Protocol for Older Adults With Emotional Distress and Reduced Mobility (NCT NCT04837521)

NCT ID: NCT04837521

Last Updated: 2025-07-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 1 week (post treatment), 1 month (post treatment)
• Results posted on: 2025-07-01

Participant Flow

Participant milestones

Measure	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	Self-Guided Unified Protocol This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	70.63 years STANDARD_DEVIATION 5.975 • n=5 Participants	69.5 years STANDARD_DEVIATION 2.268 • n=7 Participants	70.06 years STANDARD_DEVIATION 4.404 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Patient Specific Functional Scale (PSFS)	4.1667 units on a scale STANDARD_DEVIATION 1.03892 • n=5 Participants	3.4583 units on a scale STANDARD_DEVIATION 1.0974 • n=7 Participants	3.8124 units on a scale STANDARD_DEVIATION 1.095 • n=5 Participants
PROMIS Depression Total Score	24.3750 units on a scale STANDARD_DEVIATION 7.2961 • n=5 Participants	24.2500 units on a scale STANDARD_DEVIATION 5.230 • n=7 Participants	24.3125 units on a scale STANDARD_DEVIATION 6.1179 • n=5 Participants
PROMIS Anxiety Total Score	23.7500 units on a scale STANDARD_DEVIATION 2.8661 • n=5 Participants	23.7500 units on a scale STANDARD_DEVIATION 5.0071 • n=7 Participants	23.7500 units on a scale STANDARD_DEVIATION 3.9412 • n=5 Participants
Brief Experiential Avoidance Questionnaire (BEAQ)	48.50 units on a scale STANDARD_DEVIATION 8.912 • n=5 Participants	52.25 units on a scale STANDARD_DEVIATION 11.411 • n=7 Participants	50.38 units on a scale STANDARD_DEVIATION 10.079 • n=5 Participants
Cognitive Flexibility Scale (CFS)	56.6250 score on a scale STANDARD_DEVIATION 7.1101 • n=5 Participants	53.5000 score on a scale STANDARD_DEVIATION 8.3666 • n=7 Participants	55.0625 score on a scale STANDARD_DEVIATION 7.6722 • n=5 Participants
Credibility and Expectancy Questionnaire (CEQ)	5.7196 score on a scale STANDARD_DEVIATION 1.1516 • n=5 Participants	6.4218 score on a scale STANDARD_DEVIATION 0.9424 • n=7 Participants	6.1146 score on a scale STANDARD_DEVIATION 1.0647 • n=5 Participants
PROMIS Physical Function Score	32.7143 score on a scale STANDARD_DEVIATION 6.5502 • n=5 Participants	32.8889 score on a scale STANDARD_DEVIATION 6.0919 • n=7 Participants	32.8125 score on a scale STANDARD_DEVIATION 6.0797 • n=5 Participants
Gait Speed (Mean of two trials)	4.0494 seconds STANDARD_DEVIATION 1.4319 • n=5 Participants	3.5794 seconds STANDARD_DEVIATION 0.9460 • n=7 Participants	3.8144 seconds STANDARD_DEVIATION 1.1972 • n=5 Participants
Weekly Steps	3728.1786 steps/week STANDARD_DEVIATION 1572.4733 • n=5 Participants	4098.9286 steps/week STANDARD_DEVIATION 2689.6560 • n=7 Participants	3913.5536 steps/week STANDARD_DEVIATION 2136.9491 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Client Satisfaction Questionnaire (CSQ) 1 Week Post treatment	30.5 score on a scale Standard Deviation 0.756	23.38 score on a scale Standard Deviation 4.779
Client Satisfaction Questionnaire (CSQ) 1 Month Post treatment	30.88 score on a scale Standard Deviation 1.642	25.25 score on a scale Standard Deviation 3.615

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Change in Patient Specific Functional Scale (PSFS) 1 Week Post Treatment	3.4167 score on a scale Standard Deviation 2.1658	3.2500 score on a scale Standard Deviation 1.6011
Change in Patient Specific Functional Scale (PSFS) 1 Month Post Treatment	4.5833 score on a scale Standard Deviation 1.8148	4.2500 score on a scale Standard Deviation 1.7067

PRIMARY outcome

Timeframe: 1 Month Post Treatment

Retention of participants through completion of the study

Outcome measures

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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Change in PROMIS-depression 1 Week Post Treatment	-4.8750 score on a scale Standard Deviation 5.8417	-1.875 score on a scale Standard Deviation 6.4901
Change in PROMIS-depression 1 Month Post Treatment	-6.2500 score on a scale Standard Deviation 5.1478	-4.625 score on a scale Standard Deviation 4.5336

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Change in PROMIS-anxiety 1 Week Post Treatment	-4.000 score on a scale Standard Deviation 7.5024	-1.1250 score on a scale Standard Deviation 4.7940
Change in PROMIS-anxiety 1 Month Post Treatment	-6.5000 score on a scale Standard Deviation 6.7612	-5.375 score on a scale Standard Deviation 3.0677

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Brief Experiential Avoidance Questionnaire (BEAQ). 1 Week Post	-11.8750 units on a scale Standard Deviation 12.4147	-9.0000 units on a scale Standard Deviation 9.0396
Brief Experiential Avoidance Questionnaire (BEAQ). 1 Month Post	-11.2500 units on a scale Standard Deviation 16.2195	-8.5000 units on a scale Standard Deviation 7.010

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Cognitive Flexibility Scale (CFS) 1 Week Post Treatment	4.37 score on a scale Standard Deviation 7.0495	-2.0000 score on a scale Standard Deviation 10.7836
Cognitive Flexibility Scale (CFS) 1 Month Post Treatment	4.7500 score on a scale Standard Deviation 5.4182	6.8750 score on a scale Standard Deviation 8.4589

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Southampton Mindfulness Questionnaire (SMQ) 1 Week Post Treatment	12.2857 score on a scale Standard Deviation 17.5187	7.1111 score on a scale Standard Deviation 16.1976
Southampton Mindfulness Questionnaire (SMQ) 1 Month Post Treatment	22.4286 score on a scale Standard Deviation 10.0155	14.3125 score on a scale Standard Deviation 17.1298

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
PROMIS Physical Function Score 1 Week Post Treatment	2.4286 score on a scale Standard Deviation 4.4293	2.3333 score on a scale Standard Deviation 2.5495
PROMIS Physical Function Score 1 Month Post Treatment	2.4286 score on a scale Standard Deviation 4.2370	-0.7777 score on a scale Standard Deviation 4.9441

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Gait Speed 1 week before treatment (baseline)	4.049 seconds Standard Deviation 1.4319	3.579 seconds Standard Deviation 0.9460
Gait Speed 1 Week Post Treatment	3.8983 seconds Standard Deviation 1.1390	3.6650 seconds Standard Deviation 0.9939

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Weekly Steps Week 4 in treatment	30933.3750 steps Standard Deviation 20550.41131	35602.000 steps Standard Deviation 24011.11186
Weekly Steps Baseline	26097.25 steps Standard Deviation 11007.31312	28692.5 steps Standard Deviation 18827.59205
Weekly Steps Week 1 in treatment	24075.25 steps Standard Deviation 13210.29827	30716.8750 steps Standard Deviation 21695.55241
Weekly Steps Week 2 in treatment	26809.3750 steps Standard Deviation 14895.31271	32359.7500 steps Standard Deviation 20783.19429
Weekly Steps Week 3 in treatment	30367.875 steps Standard Deviation 24098.26813	43975.50 steps Standard Deviation 36506.15559
Weekly Steps The week after treatment	26254.7143 steps Standard Deviation 17190.26649	40353.6250 steps Standard Deviation 26573.42281
Weekly Steps the week following a month after treatment	29993.25 steps Standard Deviation 23367.89734	38454.8333 steps Standard Deviation 35403.89371

SECONDARY outcome

Timeframe: one week after treatment, one month after treatment

Population: Mean scores

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).

Outcome measures

Measure	Therapist Delivered Unified Protocol n=8 Participants This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 Participants This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Credibility and Expectancy Score One week after treatment	8.3000 units on a scale Standard Deviation 0.8751	6.550 units on a scale Standard Deviation 1.4570
Credibility and Expectancy Score One month after treatment	7.8250 units on a scale Standard Deviation 1.0222	6.775 units on a scale Standard Deviation 1.317

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Therapist Delivered Unified Protocol n=14 Number of sessions This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Percent of Adherent Sessions Completed in the Therapist Delivered Arm of the Study.	92.3 percent of sessions coded at adherence	—

Adverse Events

Therapist Delivered Unified Protocol

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Self-Guided Unified Protocol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Therapist Delivered Unified Protocol n=8 participants at risk This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 participants at risk This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
Cardiac disorders Bradycardia	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
Musculoskeletal and connective tissue disorders Broken Wrist/Ribs/Jaw	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)

Other adverse events

Measure	Therapist Delivered Unified Protocol n=8 participants at risk This is a five session psychotherapy designed to help people with problems such as anxiety and depression. Unified Protocol: Five session psychotherapy	Self-Guided Unified Protocol n=8 participants at risk This is a five session treatment that patients can complete independently. Unified Protocol: Five session psychotherapy
General disorders Respiratory Virus	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
Musculoskeletal and connective tissue disorders Twisted Ankle	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
General disorders Accidental Fall	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
Surgical and medical procedures Fatigue post oral surgery	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
Musculoskeletal and connective tissue disorders Pulled Muscle	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)
Musculoskeletal and connective tissue disorders Broken Wrist	12.5% 1/8 • Number of events 1 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)	0.00% 0/8 • Reports of adverse events were self reported by participants during their enrollment in the study. (weeks 0 - 12 from intake)

Additional Information

Dr. Andrada Neacsiu

Duke University

Phone: +1 919 684 6714

Email: andrada.neacsiu@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place