An interventional study of Resourcefulness Training in Depressive Symptoms, Multiple Chronic Conditions and Family Caregivers, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Supportive care
Among 3,706 studies in Depression with a site in United States — 576 open to participants now, 716 under way, 30 of them phase 3. Depression · United States.
Among the 3,706 studies in Depression with a site in United States, this one is the 1,434th largest by enrollment of the 3,313 interventional ones, is one of 164 that started in 2018, is one of 2,213 with no phase, and was the 1,903rd registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 93 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →576 of the 3,706 studies in Depression with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →3,706 studies; the count open now beside each. This study's row is marked.
First in 1977; this study’s year is marked. 164 started in 2018.
Median enrollment 72 across the 3,313 interventional studies, 138 across the 371 observational. Of the 2,759 that completed or were terminated, 1,045 (38%) have results posted.
392 of 3,706 have an industry lead sponsor. The 10 most frequent:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 3 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Among the 3,706 studies in Depression with a site in United States, from their registry updates:
Technology-dependent children, those who live at home but rely on medical equipment such as mechanical ventilation or feeding tubes, require complex care for their chronic condition. Parents usually provide a majority of their care and are often overwhelmed by the caregiving demands resulting in deterioration of their own mental and physical health. The goal of this 2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral Resourcefulness Training intervention that includes teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The intervention is proposed to improve these caregivers' mental and physical health outcomes and family functioning outcomes while they continue to provide vital care for these vulnerable children.
Technology-dependent children, those who rely on medical equipment such as mechanical ventilation or feeding tubes for daily care at home, are among the sickest and most vulnerable subset of children with complex chronic conditions. An estimated 600,000 children in the United States are technology dependent and live at home, and are cared for primarily by their parents. These parents report greater levels of depressive symptoms and stress than other caregiver groups. In addition, these caregivers report poor psychological and physical health that compromise their caregiving capacity and increase their use of emergency rooms (ER) for their children's care needs. Despite these adverse consequences, there are no interventions to meet the needs of these caregivers and their children. Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients. It will be tested in a randomized trial against an attention-only control arm. The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment. The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care. The aims of the study are to: 1) Determine whether Resourcefulness Training versus Attention Control improves psychological (general mental health, depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general physical health, chronic stress [hair cortisol]) and family functioning over 6 months in parents of technology-dependent children, after controlling for the parents' race/ethnicity, sex, family income, and children's functional status; and 2) Determine whether changes in psychological and physical outcomes and family functioning are mediated by changes in parents' levels of resourcefulness (personal and social). Data collection will take place at baseline then 6 weeks, 3 months, and 6 months post-enrollment. Our study will be the first to test a resourcefulness intervention for this caregiver population and to include male as well as female caregivers. This intervention is distinctive in that it uses web, telephone, and journal components for reinforcement-not multiple face-to-face visits that can be labor intensive. If shown to be efficacious, it can be easily replicated with other populations with strong potential for translation into practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Behavioral: Resourcefulness Training
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
Depressive Cognitions Scale
Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
Time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
Time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
Time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Feetham Family Functioning Survey
Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations
Time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Resourcefulness Scale
Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
Time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
| Milestone | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| Started | 46 | 47 |
| Completed | 26 | 44 |
| Not completed | 20 | 3 |
| Withdrew: Lost to follow-up | 5 | 3 |
| Withdrew: Protocol violation | 4 | 0 |
| Withdrew: Withdrawal by subject | 11 | 0 |
Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
| Score on a Scale | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| 6 Weeks Post Enrollment Timepoint | 6.46 (0 to 21) | 6.97 (0 to 26) |
| 3 Months Post Enrollment Timepoint | 6.32 (0 to 23) | 7.28 (0 to 32) |
| 6 Months Post Enrollment Timepoint | 5.65 (0 to 23) | 7.93 (0 to 40) |
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
| Score on a Scale | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| 6 Weeks Post Enrollement Timepoint 2 | 52.7 (27 to 64.74) | 50.77 (28.26 to 66.51) |
| 3 Months Post Enrollment Timepoint 3 | 54.49 (28.39 to 67.02) | 49.46 (23.19 to 65.04) |
| 6 Months Post Enrollment Timepoint 4 | 51.49 (24.78 to 64.96) | 49.81 (24.43 to 62.29) |
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
| Score on a Scale | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| 6 Weeks Post-Enrollment, Timepoint 2 | 47.02 (22.17 to 63.97) | 45.69 (17.8 to 61.42) |
| 3 Months Post-Enrollment, Timepoint 3 | 45.54 (26.17 to 63.5) | 47.41 (28.67 to 64.47) |
| 6 Weeks Post-Enrollment, Timepoint 4 | 49.51 (26.17 to 63.89) | 46.79 (15.15 to 62.05) |
Change in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations
| Score on a Scale | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| 6 Weeks Post Enrollment Timepoint | 34.96 ± 22.01 | 36.38 ± 22.32 |
| 3 Months Post Enrollment Timepoint | 39.26 ± 22.83 | 37.44 ± 24.32 |
| 6 Months Post Enrollment Timepoint | 38.30 ± 23.66 | 32.43 ± 19.55 |
Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
| Score on a Scale | Resourcefulness Training Intervention | Attention Control |
|---|---|---|
| 6 Weeks Post Enrollment Timepoint | 86.12 (50 to 125) | 93.59 (58 to 118) |
| 3 Months Post Enrollment Timepoint | 87.47 (60 to 102) | 88.22 (40 to 125) |
| 6 Months Post Enrollment Timepoint | 89.17 (22 to 121) | 93.59 (58 to 118) |
Collected over No adverse events were reported during the 6 month data collection period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resourcefulness Training Intervention | 0/46 (0%) | 0/47 (0%) | 0/46 (0%) |
| Attention Control | 0/47 (0%) | 0/46 (0%) | 0/47 (0%) |
| Age, Categorical(Participants) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 45 | 90 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(Years) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| Mean | 39.5 ± 9.9 | 38.7 ± 10.8 | 39.1 ± 10.3 |
| Sex: Female, Male(Participants) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| Female | 38 | 40 | 78 |
| Male | 8 | 7 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 43 | 44 | 87 |
| Race (NIH/OMB)(Participants) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 14 | 24 |
| White | 30 | 28 | 58 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Region of Enrollment(participants) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| United States | 46 | 47 | 93 |
| General Physical Health(units on a scale) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| Mean | 51.32 (27.33 to 67.74) | 49.48 (29.86 to 63.95) | 50.4 (27.33 to 67.74) |
| General Mental Health(units on a scale) | Resourcefulness Training Intervention | Attention Control | Total |
|---|---|---|---|
| Mean | 42.6 (23.28 to 64.75) | 42.45 (17.48 to 60.68) | 42.5 (17.48 to 64.75) |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The study team is still conducting analysis and writing up study results for publication.
Ran from Feb 2018 to primary completion in Dec 2019, 22 months.
Results were first posted in Oct 2021, 1 year 10 months after primary completion.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 22 months is close to that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center →