NCT05996718

Improving Care Through Improv: Promoting Mastery in the Moment

Completed NA Results posted Last updated 11 June 2025

What this trial tests

NA trial testing Training program pilot in Caregiver Burden in 43 participants. Completed in 20 May 2024.

Timeline

25 October 2023

Primary endpoint
20 May 2024

20 May 2024

Quick facts

Lead sponsor	Georgia State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	43
Start date	25 October 2023
Primary completion	20 May 2024
Estimated completion	20 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Training program pilot

Conditions studied

• Caregiver Burden — all drugs for Caregiver Burden →

Sponsor

Georgia State University

Who can join

18 and older, any sex, with Caregiver Burden. 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.

Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale Primary · at baseline, upon training completion (Week 4), and three months post baseline.

4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.

Baseline

Group	Value	95% CI
Caregivers	11.10	± 2.31

Month 1

Group	Value	95% CI
Caregivers	11.63	± 2.07

Month 3

Group	Value	95% CI
Caregivers	11.93	± 2.06

Perceived Stress Scale Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.

Baseline

Group	Value	95% CI
Caregivers	26.25	± 8.43

Month 1

Group	Value	95% CI
Caregivers	26.65	± 9.45

Month 3

Group	Value	95% CI
Caregivers	23.10	± 8.16

Center for Epidemiological Studies-Depression Scale Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.

Baseline

Group	Value	95% CI
Caregivers	14.83	± 9.30

Month 1

Group	Value	95% CI
Caregivers	14.78	± 9.45

Month 3

Group	Value	95% CI
Caregivers	12.98	± 9.40

State-Trait Anxiety Inventory Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.

Baseline

Group	Value	95% CI
Caregivers	36.15	± 10.27

Month 1

Group	Value	95% CI
Caregivers	35.38	± 11.09

Month 3

Group	Value	95% CI
Caregivers	34.85	± 11.62

Zarit Burden Inventory Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.

Baseline

Group	Value	95% CI
Caregivers	61.95	± 16.32

Month 1

Group	Value	95% CI
Caregivers	61.63	± 15.19

Month 3

Group	Value	95% CI
Caregivers	59.68	± 16.43

Revised Memory and Behavioral Problems Checklist - FREQUENCY Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.

Baseline

Group	Value	95% CI
Caregivers	37.20	± 14.21

Month 1

Group	Value	95% CI
Caregivers	36.55	± 11.99

Month 3

Group	Value	95% CI
Caregivers	38.05	± 13.78

Quality of Life-Alzheimer's Disease Scale Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia

Baseline

Group	Value	95% CI
Caregivers	27.85	± 5.15

Month 1

Group	Value	95% CI
Caregivers	27.88	± 4.20

Month 3

Group	Value	95% CI
Caregivers	27.63	± 5.16

Revised Memory and Behavioral Problems Checklist - REACTION Secondary · at baseline, upon training completion (Week 4), and three months post baseline.

24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.

Baseline

Group	Value	95% CI
Caregivers	20.13	± 13.27

Month 1

Group	Value	95% CI
Caregivers	19.70	± 12.21

Month 3

Group	Value	95% CI
Caregivers	16.35	± 12.05

Sponsor's own description

The goals of this clinical trial are to: 1) refine the training program, "Improving Care though Improv;" and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. Forty-three informal caregivers will be involved in testing the training program. These individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. This group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving Care through Improv: pilot test results of an innovative training program for care partners of people living with dementia.
   Kemp CL, Anglin E, Morgan JC, Johnson Ii TM. · · 2026 · PMID 41181875 · DOI 10.1093/geront/gnaf240