18 and older, any sex, with Anxiety or Burden, Dependency. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Anxiety Symptoms, as Measured by PROMIS Anxiety Short FormPrimary· Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Anxiety was measured with the PROMIS Anxiety short-form questionnaire for adults, a self-report, 8-item additive scale that standardizes the distribution of anxiety-related symptoms (T-score) on a population-distribution with a mean of 50 and standard deviation of 10: "During the past 7 days, I felt nervous, anxious, fearful, uneasy, tense, worried, unable to focus on anything other than my anxiety, felt like I needed help with my anxiety" each assessed with a five-category response (never, rarely, sometimes, often, always). Higher scores indicate a higher level of anxiety.
T0 - baseline, Pre-Intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
55.51
53.48 – 57.53
Wait-List / Control Treatment With Follow-up (Group B)
53.93
51.95 – 55.90
T4
Group
Value
95% CI
Treatment With Follow-up (Group A)
56.75
54.65 – 58.86
Wait-List / Control Treatment With Follow-up (Group B)
57.35
55.50 – 59.21
T8
Group
Value
95% CI
Treatment With Follow-up (Group A)
56.39
54.38 – 58.40
Wait-List / Control Treatment With Follow-up (Group B)
56.99
55.38 – 58.59
T12
Group
Value
95% CI
Treatment With Follow-up (Group A)
56.92
54.76 – 59.09
Wait-List / Control Treatment With Follow-up (Group B)
54.20
52.53 – 55.86
T16 - Post Intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
56.54
54.24 – 58.85
Wait-List / Control Treatment With Follow-up (Group B)
52.75
50.75 – 54.75
T20 - Follow-up
Group
Value
95% CI
Treatment With Follow-up (Group A)
58.15
55.79 – 60.52
Wait-List / Control Treatment With Follow-up (Group B)
55.73
53.69 – 57.77
Caregiver Burden Score, as Measured by "Caregiver Burden Inventory"Primary· Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Self-report multi-item index (24 items; range 0-96). Lower scores indicate lower levels of caregiver burden. Higher scores indicate higher levels of perceived burden associated with caregiving tasks.
T0 - Baseline
Group
Value
95% CI
Treatment With Follow-up (Group A)
45.94
42.22 – 49.65
Wait-List / Control Treatment With Follow-up (Group B)
46.10
42.40 – 49.79
T4
Group
Value
95% CI
Treatment With Follow-up (Group A)
45.33
41.39 – 49.27
Wait-List / Control Treatment With Follow-up (Group B)
43.22
40.50 – 45.95
T8 - mid intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
45.02
41.37 – 48.66
Wait-List / Control Treatment With Follow-up (Group B)
43.37
40.16 – 46.58
T12
Group
Value
95% CI
Treatment With Follow-up (Group A)
45.72
41.66 – 49.78
Wait-List / Control Treatment With Follow-up (Group B)
40.80
37.65 – 43.94
T16 - Post intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
49.91
45.57 – 54.26
Wait-List / Control Treatment With Follow-up (Group B)
42.05
38.31 – 45.79
T20 - follow up
Group
Value
95% CI
Treatment With Follow-up (Group A)
50.09
45.47 – 54.71
Wait-List / Control Treatment With Follow-up (Group B)
43.23
40.01 – 46.46
Respite Time-Use (in Hours Per Week)Secondary· Pre-Intervention (baseline, week 1) and Post-Intervention (week-16) for both Group A and Group B
Participants were asked to self-report number of hours they typically receive respite in a typical week. The following survey question and description were asked to all participants "On average, how many hours of respite do you get in a typical week? These would be hours that you can completely turn-off your caregiving responsibilities, while the needs and safety of your family member are not your primary responsibility."
Pre Intervention
Group
Value
95% CI
Treatment With Follow-Up (Group A)
8.77
± 8.89
Wait-List/Control Treatment With Follow-up (Group B)
7.81
± 11.01
Post Intervention
Group
Value
95% CI
Treatment With Follow-Up (Group A)
13.44
± 12.64
Wait-List/Control Treatment With Follow-up (Group B)
13.11
± 10.82
Respite Satisfaction: Count (%) of Participants Who Agreed or Strongly Agreed With the Statement "I am Happy With What I Choose to do During Respite"Secondary· Pre-Intervention (baseline, week 1) and Post-Intervention (week 16) for both Group A and Group B
Self-report single item measure, assessing partcipants' perceived level of satisfaction with their respite time and time use. Respondents were asked about their level of agreement with the following statement: "I am happy with what I choose to do during my respite time". Responses were recorded on a five-point Likert scale with strongly disagree=1 and strongly agree 5. This variable is dichotomized, showing the count (and percentage) of the sample that responded with "agree" or "stongly agree." This self-report assessment was only collected at baseline (pre-intervention) and at time 16 (post-i
Pre Intervention (baseline, week 1)
Group
Value
95% CI
Treatment With Follow-Up (Group A)
38
Waitlist/Control Treatment With Follow-Up (Group B)
34
Post Intervention (week 16)
Group
Value
95% CI
Treatment With Follow-Up (Group A)
61
Waitlist/Control Treatment With Follow-Up (Group B)
59
Depressive Symptoms, as Measured by the "PROMIS Depression Scale (Vol 1 Short Form)"Secondary· Baseline (week 1, pre-intervention), week 4, week 8, week 12, week 16 (post-intervention) and week 20 (follow-up) for both Group A and Group B
Self-report multi-item index (8-items, additive), with higher scores indicating greater presence and frequency of depressive symptoms; scores are standardized to a distribution of depression-related symptoms on a population-distribution with a mean of 50 and standard deviation of 10 (T-score). Participants self-reported to the following survey questions: "During the past 7 days, I felt worthless, helpless, depressed, hopeless, like a failure, unhappy, that I had nothing to look forward to, that nothing could cheer me up," each assessed with a five-category response (never, rarely, sometimes, o
T0 - preintervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
54.34
52.76 – 55.92
Wait-List / Control Treatment With Follow-up (Group B)
53.92
52.22 – 55.61
T4
Group
Value
95% CI
Treatment With Follow-up (Group A)
55.81
54.21 – 57.41
Wait-List / Control Treatment With Follow-up (Group B)
55.18
53.61 – 56.74
T8 - mid intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
54.68
52.81 – 56.55
Wait-List / Control Treatment With Follow-up (Group B)
54.38
52.76 – 56.00
T12
Group
Value
95% CI
Treatment With Follow-up (Group A)
55.73
53.88 – 57.58
Wait-List / Control Treatment With Follow-up (Group B)
53.19
51.75 – 54.63
T16 - post-intervention
Group
Value
95% CI
Treatment With Follow-up (Group A)
54.75
52.86 – 56.64
Wait-List / Control Treatment With Follow-up (Group B)
52.52
50.65 – 54.39
T20 - follow-up
Group
Value
95% CI
Treatment With Follow-up (Group A)
56.25
54.43 – 58.05
Wait-List / Control Treatment With Follow-up (Group B)
53.85
52.08 – 55.62
Sponsor's own description
The "Time for Living \& Caring" (TLC) intervention is an online, self-administered intervention, with the purpose of providing informal family caregivers with resources, support, and education to maximize the benefit of their respite time-use (respite is defined as planned time away from caregiving; it can be provided by a formal service provider or informal arrangements within families/networks). The study will use a full-powered pilot sample (anticipated n=150; actual n=166) and a randomized waitlist control design to examine feasibility and initial efficacy of the TLC intervention.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Utah
Last refreshed: 15 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03689179.