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Completed

NCT Number: NCT05996718

Improving Care Through Improv: Promoting Mastery in the Moment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30302, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months
  • Able to attend at least 3 of the 4 in-person sessions
  • Ability to communicate in English

Exclusion criteria

Potential participants were excluded if they did not meet the above criteria or anticipated moving their person to a skilled nursing facility within the next 6 months.

Treatment and study plan

Training program pilot

Behavioral

This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.

Primary outcomes

  1. Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale

    Time frame: 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.

Secondary outcomes

  1. Perceived Stress Scale

    Time frame: 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.

  2. Center for Epidemiological Studies-Depression Scale

    Time frame: 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.

  3. State-Trait Anxiety Inventory

    Time frame: 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.

  4. Zarit Burden Inventory

    Time frame: 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.

  5. Revised Memory and Behavioral Problems Checklist - FREQUENCY

    Time frame: 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.

  6. Quality of Life-Alzheimer's Disease Scale

    Time frame: 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

  7. Revised Memory and Behavioral Problems Checklist - REACTION

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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