iPath for CP Pilot (care partners)

June 12, 2026 updated by: Lisa A. Mistler, Dartmouth-Hitchcock Medical Center

Improving Screening and Access to Treatment for Depression in Care Partners of People Living With Dementia

Depression is a significant problem in care partners of people living with dementia; despite the expansion of options for accessing evidence-based treatments, most care partners of people living with dementia are not screened for depression and do not receive treatment. The objective of this project is to identify a screening method for depression that is feasible and acceptable to care partners and to adapt an innovative pathway to online evidence-based treatment for depression (iPath*D) as a means of increasing mental health literacy, screening rates and treatment access for care partners of people living with dementia. The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to evidence based treatment with the potential for reaching an unprecedented number of care partners who have unmet mental health needs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Depression affects up to 34% of care partners (CP) of people living with dementia (PLWD) each year and despite the expansion of treatments, most individuals do not receive treatment. Three key barriers to treatment exist: low detection, low mental health literacy (MHL) and limited treatment accessibility, exacerbated in rural settings. Innovative informatics solutions to barriers exist including automating screening, enhancing MHL through decision aids (DA) and increasing accessibility via location-independent, online treatments. Yet there is a gap in identifying strategies to screen and connect CP of PLWD with unmet mental health needs to treatments. The objective for this GEMSSTAR is to modify an innovative application, iPATH*D, developed previously by the research team, for CP of PLWD. iPath*D is an online platform that connects patients screening positive for clinically significant depression in rural cancer settings to a range of online and in-person evidence-based treatments. Investigators plan to adapt both the content and implementation of iPath*D, then establish its acceptability, usability, and feasibility, overcoming the unique challenges to help-seeking CP of PLWD. The specific aims are: Aim 1. Optimize and assess feasibility and acceptability of a pathway to identify care partners of persons living with dementia at risk for depression; and Aim 2. Determine feasibility, acceptability, and usability of implementing iPath*D with care partners of persons living with dementia and its preliminary impact on MHL, screening and treatment rates. The study tests the hypotheses that: (1) iPath*D will be acceptable and highly usable and will demonstrate preliminary impact of increased MHL, screening rates and treatment access. The development of iPath*D follows a user centered design model. In Aim 1 care partners (n=15) will co-design iPath*D via participatory design activities to inform the adaptations needed to the design and functionality of iPath*D, and development of low and high-fidelity iPath*D prototypes, which will go through rounds of iterative development, with extensive usability evaluations, ensuring iPath*D surpasses usability metrics. In Aim 2, an open label, single arm pilot, 15 care partners screening positive for depression will receive iPath*D. Real world usability, acceptability and feasibility will be assessed, and preliminary data on MHL, rates of screening and treatment access, treatment initiation, adherence, change in caregiver burden, and depression symptom improvement will be gathered. This research is innovative in developing and testing a novel services delivery model (iPath*D) that addresses existing barriers to care. The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to treatment with the potential for reaching an unprecedented number of individuals in rural settings with unmet mental health needs by understanding and implementing the optimal design of an innovative model of services delivery for CP of PLWD who experience depression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • For 2 Week iPath*CP Pilot:

    1. Adults (≥18 years)
    2. Care partners of persons with dementia who score ≥5 on the PHQ-8 AND PHQ-9 screen
    3. Can communicate in English
    4. Have access to an Android based or Apple iOS based phone or tablet capable of running the iPath application.

For Debrief Interviews:

  • Care partners: Interviews will be conducted with a purposeful sample of 6 patients already consented into the study at the completion of T1 data collection, ensuring representation by sex (male/female), perceived usability (low/high) of iPath*CP and race/ethnicity.
  • Clinicians: Interviews will be conducted with clinicians and clinical staff who had patients involved in the project.

Exclusion Criteria:

  • Care partners with:

    1. PHQ-8 score <5
    2. Answering positively for question 9 of the PHQ-9 who also screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6b ("Past 3 Months") on the Columbia-Suicide Severity Rating Scale (C-SSRS) and determined by Dr. Mistler, Psychiatrist at DH, not to be eligible.
    3. With bipolar disorder or psychosis (documented in the electronic medical record [EMR])
    4. With significant cognitive impairment (documented in the EMR or self-reported during eligibility screening)
    5. With no access to an Android or Apple device

For Debrief Interviews:

  • Patients: Participants withdrawn from the 2 Week iPath*CP Pilot.
  • Clinicians: None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: iPath*CP app intervention arm
Care partners will upload the iPath*CP app and use it for 2 weeks. The app itself will screen for depression, provide information about depression in care partners of persons with dementia, offer a decision aid regarding depression treatments, and provide a curated list of treatment options.
Other: depression app for care partners of persons with dementia
iPath*CP is an app designed to screen for depression in care partners of persons with dementia, provide specific information about depression in care partners of persons with dementia, offers a decision aid to assist in deciding on treatment and also offers a curated list of potential treatment options, sortable by cost and time to access.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Usability of Intervention
Time Frame: Assessed after initial use of iPath app at T1 (2 weeks)
System Usability Scale --a widely used, free questionnaire that measures the perceived usability of a product, system, or website. Developed by John Brooke in 1986, it provides a quick, reliable, and standardized way to capture subjective user feedback after they interact with a product. 10 items. Each item uses a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Score ranges from 0 - 100 points, with lower scores indicating less perceived usability.
Assessed after initial use of iPath app at T1 (2 weeks)
Acceptability of Intervention
Time Frame: Assessed at end of study, T1 (2 weeks)
Acceptability of Intervention Measure -- A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree). Score is calculated mean, with higher scores indicating greater acceptability.
Assessed at end of study, T1 (2 weeks)
Feasibility of Intervention
Time Frame: Assessed at end of study, T1 (2 weeks)
Feasibility of Intervention Measure. A 4-item measure of perceived intervention feasibility. Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree). Score is calculated mean, with higher scores indicating greater perceived feasibility.
Assessed at end of study, T1 (2 weeks)
Appropriateness of Intervention
Time Frame: Assessed at end of study, T1 (2 weeks)
Appropriateness of Intervention Measure. A 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree). Score is calculated mean, with higher scores indicating greater perceived appropriateness.
Assessed at end of study, T1 (2 weeks)
Treatment access
Time Frame: Assessed at end of study, T1 (2 weeks)
Proportion of participants selecting a treatment path to access e.g., participants clicked on link to access online treatment service or indicated in self-report survey that they accessed local resources
Assessed at end of study, T1 (2 weeks)
Mental health literacy
Time Frame: Change between T0 and T1 (2 weeks)
A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding & beliefs. Some questions are "true-false" and some are 4 choice multiple choice. Higher overall score (number correct out of 10 total) indicates better understanding of depression and its treatments.
Change between T0 and T1 (2 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PHQ-9 completion
Time Frame: Assessed at T0 and at 2 weeks (T1)
Proportion of participants out of total completing the PHQ-9 survey in iPath*CP app at T0 and T1 (≥70% completing PHQ-9 is our target). PHQ-9 itself is a standard depression screen with 9 items. Each of the 9 items is rated on a scale of 0 to 3 based on how often the problem has bothered the participant: 0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Overall score ranges from 0 to 27, with 27 indicating severe depression.
Assessed at T0 and at 2 weeks (T1)
Treatment initiation
Time Frame: Assessed at end of study, T1 (2 weeks)
Proportion of participants that self-report treatment initiation e.g., filled antidepressant prescription, visited with psychiatrist or therapist for talk therapy, began a cCBT program.
Assessed at end of study, T1 (2 weeks)
Treatment adherence
Time Frame: Assessed at end of study, T1 (2 weeks)
Proportion of participants that self-report continuing to adhere to treatment e.g., antidepressant refill (yes/no), number of talk therapy sessions completed, number of cCBT modules completed.
Assessed at end of study, T1 (2 weeks)
Decisional regret
Time Frame: Assessed at end of study, T1 (2 weeks)
The Decisional Regret Scale assesses decisional regret with a healthcare decision. The Decisional Regret Scale is a 5-item Likert scale. Respondents read each statement and use the response options to indicate how much they agree or disagree with the statement. The scale numbers range from strongly agree (1) to strongly disagree (5). A total of 0 = no regret and 100 indicates high regret.
Assessed at end of study, T1 (2 weeks)
Symptom monitoring - PHQ-9
Time Frame: Change across 2 week period
Response, 5-point reduction in baseline PHQ-9 score. PHQ-9 is a standard depression screen with 9 items. Each of the 9 items is rated on a scale of 0 to 3 based on how often the problem has bothered the participant: 0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Overall score ranges from 0 to 27, with 27 indicating severe depression. Remission; PHQ-9 score of <5.
Change across 2 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa A Mistler, MD, Dartmouth-Hitchcock Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY02003455
  • R03AG088962-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings