DementiaIPPINCT05980299
Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)
A study testing Individualized Positive Psychosocial Interaction in people with Dementia and Depression, run by Miami University at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Dementia, Depression, Behavior
- What is being tested?
- Individualized Positive Psychosocial Interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Jul 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Exclusion Criteria: Nursing home residents who are expected to live in the community for less than 6 months.
- -
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Trinity Community at Beavercreek
Beavercreek, Ohio, 45440
The Chapel Hill Community
Canal Fulton, Ohio, 44614
The Trinity Community at Fairborn
Fairborn, Ohio, 45324
The Four Winds Community
Jackson, Ohio, 45640
The Harmar Place Community
Marietta, Ohio, 45750
SEM Haven
Milford, Ohio, 45150
The Parkvue Community
Sandusky, Ohio, 44870
About this study
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.
Read the detailed description
Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people living with dementia (PLWD) are challenging to respond to in nursing home (NH) care. Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and resistance or refusal of care.1 In addition, 30% of NH residents experience depressive symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these conditions will be referred to as distress throughout this proposal. Without appropriate guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent or positively remediate distress experienced by PLWD. The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program designed to support care partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities. IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses using non-pharmacological approaches that align care with residents' preferences recorded in Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI program delivered by care partners experienced more pleasure, alertness, engagement, and positive verbal behavior compared with the usual care group.
Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old nonprofit national senior living provider to conduct a full implementation feasibility pilot of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D) of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) and/or 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).
Care partners of identified residents will be invited to be trained to deliver IPPI. The investigators anticipate that each NH will initiate engagement with 4-5 residents per month for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis (i.e., initiating intervention activities for a given resident when he/she is due for a routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions per week for 6 months. The project seeks to achieve the following specific aims:
Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents. Quantitative implementation endpoints indicating success include (a) that staff in each community will be able to identify and engage 12-15 residents experiencing both dementia (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks, measured by a count of participants; (b) that all the implementation team members (champions and care partners) can complete the online training within the first two months of initiating implementation, as indicated by the learning management system; (c) that the implementation team will be able to (i) review existing data from Section F of the MDS for all selected residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI protocols; (iii) identify a targeted expression of distress as measured by documentation in the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions per week, per targeted resident with fidelity over the course of 6 months as measured in the electronic medial record (EMR). Qualitative data to evaluate implementation will be ascertained from semi-structured interviews with implementation team members in each community to assess acceptability, feasibility, and appropriateness as well as facilitators and barriers to fidelity of the IPPI sessions.
Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will consist of a single variable indicating improvement, no change, or worsening of a staff-targeted behavior of distress of each resident receiving the intervention, tracked pre- and post-IPPI intervention using routinely collected data in the EMR. Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills.
IMPACT: The IPPI program teaches care partners strategies to better identify and manage their own feelings and those of PLWD through our emotion-focused communication course. In addition, the program provides highly structured and feasible protocols to guide short but impactful interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of depression). Findings from this pilot study will guide the implementation, approach, and power needed for a full-scale Stage IV effectiveness ePCT study.
- Conditions
- Dementia, Depression, Behavior
- Being tested
- Individualized Positive Psychosocial Interaction
- Keywords
- dementia, depressive symptoms, psychosocial intervention, feasibility, emotion
- Medical subject headings
- Dementia, Depression, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Positive Psychosocial InteractionBehavioural
Also called Individualized Positive Psychosocial Intervention
The intervention involves a brief positive interaction around a preferred activity or personal care routine.
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | The experimental arm involves a brief positive interaction around a preferred activity or personal care routine. Receives: Behavioral: Individualized Positive Psychosocial Interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start10 Jul 2023
- Primary completion1 Aug 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- United Church Homes, Penn State University, Virginia Polytechnic Institute and State University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Katherine Abbott, PhD, Principal investigator, Miami University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980299
- Sponsor's protocol ID
- FY22_Pilot5_Abbott
- Other IDs
- U54AG063546, 403853
- Acronym
- IPPI
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2023
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data (IPT) available.
Publications
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.
PubMed 24304555Abbott 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.
PubMed 40460889Heid AR, Noble M, Van Haitsma K, Abbott KM. Alignment of Minimum Data Set 3.0 Ratings With Staff Care Partner Reports of Symptoms of Distress for Nursing Home Residents. J Am Med Dir Assoc. 2025 Dec;26(12):105928. doi: 10.1016/j.jamda.2025.105928. Epub 2025 Oct 27.
PubMed 41106430
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)
- ClinicalTrials.gov ID
- NCT05980299
- Acronym / sponsor ID
- IPPI / FY22_Pilot5_Abbott
- Conditions
- Dementia, Depression, Behavior
- Keywords
- dementia, depressive symptoms, psychosocial intervention, feasibility, emotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- United Church Homes, Penn State University, Virginia Polytechnic Institute and State University, National Institute on Aging (NIA)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people living with dementia (PLWD) are challenging to respond to in nursing home (NH) care. Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and resistance or refusal of care.1 In addition, 30% of NH residents experience depressive symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these conditions will be referred to as distress throughout this proposal. Without appropriate guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent or positively remediate distress experienced by PLWD. The Individualized Positive Psychosocial Intervention (IPPI) is an evidence-based program designed to support care partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities. IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses using non-pharmacological approaches that align care with residents' preferences recorded in Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI program delivered by care partners experienced more pleasure, alertness, engagement, and positive verbal behavior compared with the usual care group.
Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old nonprofit national senior living provider to conduct a full implementation feasibility pilot of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D) of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5 behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care, wandering) and/or 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).
Care partners of identified residents will be invited to be trained to deliver IPPI. The investigators anticipate that each NH will initiate engagement with 4-5 residents per month for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis (i.e., initiating intervention activities for a given resident when he/she is due for a routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions per week for 6 months. The project seeks to achieve the following specific aims:
Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents. Quantitative implementation endpoints indicating success include (a) that staff in each community will be able to identify and engage 12-15 residents experiencing both dementia (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks, measured by a count of participants; (b) that all the implementation team members (champions and care partners) can complete the online training within the first two months of initiating implementation, as indicated by the learning management system; (c) that the implementation team will be able to (i) review existing data from Section F of the MDS for all selected residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI protocols; (iii) identify a targeted expression of distress as measured by documentation in the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions per week, per targeted resident with fidelity over the course of 6 months as measured in the electronic medial record (EMR). Qualitative data to evaluate implementation will be ascertained from semi-structured interviews with implementation team members in each community to assess acceptability, feasibility, and appropriateness as well as facilitators and barriers to fidelity of the IPPI sessions.
Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will consist of a single variable indicating improvement, no change, or worsening of a staff-targeted behavior of distress of each resident receiving the intervention, tracked pre- and post-IPPI intervention using routinely collected data in the EMR. Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills.
IMPACT: The IPPI program teaches care partners strategies to better identify and manage their own feelings and those of PLWD through our emotion-focused communication course. In addition, the program provides highly structured and feasible protocols to guide short but impactful interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of depression). Findings from this pilot study will guide the implementation, approach, and power needed for a full-scale Stage IV effectiveness ePCT study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Individualized Positive Psychosocial InteractionThe experimental arm involves a brief positive interaction around a preferred activity or personal care routine. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Exclusion Criteria: Nursing home residents who are expected to live in the community for less than 6 months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Positive Psychosocial InteractionAlso: Individualized Positive Psychosocial InterventionThe intervention involves a brief positive interaction around a preferred activity or personal care routine. | Behavioural | experimental |
Primary outcome
Change in Physical Behavioral Symptoms Directed Toward Others
Time frame: 6 Months
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.
Change in Verbal Behavior Symptoms Directed Towards Others
Time frame: 6 Months
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.
Change in Other Behavioral Symptoms Not Directed Towards Others
Time frame: 6 Months
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.
Change in Rejection of Care
Time frame: 6 Months
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.
Change in Wandering
Time frame: 6 Months
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.
Change in Little Interest or Pleasure in Doing Things
Time frame: 6 Months
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)
Change in Feeling Down, Depressed or Hopeless
Time frame: 6 Months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24304555Van 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.
- Results publication: PubMed 40460889Abbott 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.
- Derived from this study: PubMed 41106430Heid AR, Noble M, Van Haitsma K, Abbott KM. Alignment of Minimum Data Set 3.0 Ratings With Staff Care Partner Reports of Symptoms of Distress for Nursing Home Residents. J Am Med Dir Assoc. 2025 Dec;26(12):105928. doi: 10.1016/j.jamda.2025.105928. Epub 2025 Oct 27.
- IPPI programLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data (IPT) available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Abbott, PhD principal investigator
Miami University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Positive Psychosocial Interaction in people with Dementia and Depression, run by Miami University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Behavioral Symptoms Directed Toward Others (time frame: 6 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980299, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.