NCT05980299

Brief Summary

The goal of this clinical trial is to test the feasibility of the Individualized Positive Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to deliver the IPPI and track impact through data collected in the electronic medical records. Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over the course of 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
8 months until next milestone

Results Posted

Study results publicly available

November 3, 2025

Completed
Last Updated

November 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

July 20, 2023

Results QC Date

June 6, 2025

Last Update Submit

October 7, 2025

Conditions

Keywords

dementiadepressive symptomspsychosocial interventionfeasibilityemotion

Outcome Measures

Primary Outcomes (7)

  • Change in Physical Behavioral Symptoms Directed Toward Others

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

  • Change in Verbal Behavior Symptoms Directed Towards Others

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

  • Change in Other Behavioral Symptoms Not Directed Towards Others

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

  • Change in Rejection of Care

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

  • Change in Wandering

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

  • Change in Little Interest or Pleasure in Doing Things

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9)

    6 Months

  • Change in Feeling Down, Depressed or Hopeless

    The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress at baseline: Minimum Data Set (MDS) Section E or MDS Section D (Patient Health Questionnaire (PHQ-9). The investigators looked at the same variable 6 months later to see if the symptom remained stable, improved, or worsened.

    6 Months

Study Arms (1)

experimental

EXPERIMENTAL

The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.

Behavioral: Individualized Positive Psychosocial Interaction

Interventions

The intervention involves a brief positive interaction around a preferred activity or personal care routine.

Also known as: Individualized Positive Psychosocial Intervention
experimental

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligibility for Individualized Positive Psychosocial Interaction (IPPI)
  • Be a long-term resident in a nursing home
  • Have a score of 0-12 on the Brief Inventory for Mental Status (BIMS)
  • Either (could be both) on their most recent Minimum Data Set (MDS) 3.0 assessment A score of 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) A score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor appetite, restlessness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Trinity Community at Beavercreek

Beavercreek, Ohio, 45440, United States

Location

The Chapel Hill Community

Canal Fulton, Ohio, 44614, United States

Location

The Trinity Community at Fairborn

Fairborn, Ohio, 45324, United States

Location

The Four Winds Community

Jackson, Ohio, 45640, United States

Location

The Harmar Place Community

Marietta, Ohio, 45750, United States

Location

SEM Haven

Milford, Ohio, 45150, United States

Location

The Parkvue Community

Sandusky, Ohio, 44870, United States

Location

Related Publications (2)

  • Van Haitsma KS, Curyto K, Abbott KM, Towsley GL, Spector A, Kleban M. A randomized controlled trial for an individualized positive psychosocial intervention for the affective and behavioral symptoms of dementia in nursing home residents. J Gerontol B Psychol Sci Soc Sci. 2015 Jan;70(1):35-45. doi: 10.1093/geronb/gbt102. Epub 2013 Dec 4.

    PMID: 24304555BACKGROUND
  • Abbott KM, Heid AR, Noble M, Kotterman A, Unroe K, Van Haitsma K. An Embedded Pragmatic Clinical Trial of the Individualized Positive Psychosocial Interaction (IPPI) Program. J Am Med Dir Assoc. 2025 Aug;26(8):105700. doi: 10.1016/j.jamda.2025.105700. Epub 2025 Jun 12.

Related Links

MeSH Terms

Conditions

DementiaDepressionBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral Symptoms

Results Point of Contact

Title
Dr. Katherine Abbott
Organization
Miami University

Study Officials

  • Katherine Abbott, PhD

    Miami University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 7, 2023

Study Start

July 10, 2023

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

November 3, 2025

Results First Posted

November 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data (IPT) available.

Locations