Depression - Major Depressive Disordercare partnersNCT07631247
iPath for CP Pilot
A study testing depression app for care partners of persons with dementia in people with Depression - Major Depressive Disorder, run by Dartmouth-Hitchcock Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- depression app for care partners of persons with dementia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For 2 Week iPath*CP Pilot:
- Adults (≥18 years)
- Care partners of persons with dementia who score ≥5 on the PHQ-8 AND PHQ-9 screen
- Can communicate in English
- 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.
Who cannot join
- Care partners with:
- PHQ-8 score <5
- 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.
- With bipolar disorder or psychosis (documented in the electronic medical record [EMR])
- With significant cognitive impairment (documented in the EMR or self-reported during eligibility screening)
- With no access to an Android or Apple device
Show all 9Show fewer
- For Debrief Interviews:
- Patients: Participants withdrawn from the 2 Week iPath*CP Pilot.
- Clinicians: None.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- depression app for care partners of persons with dementia
- Keywords
- depression, caregiver, AD/ADRD, Alzheimer's disease, dementia, care partner, app
- Medical subject headings
- Depression, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depression app for care partners of persons with dementiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| iPath*CP app intervention arm | Experimental | 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. Receives: Other: depression app for care partners of persons with dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Intervention
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.
Measured: Assessed after initial use of iPath app at T1 (2 weeks)
Acceptability of Intervention
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.
Measured: Assessed at end of study, T1 (2 weeks)
Feasibility of Intervention
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.
Measured: Assessed at end of study, T1 (2 weeks)
Appropriateness of Intervention
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.
Measured: Assessed at end of study, T1 (2 weeks)
Treatment access
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
Measured: Assessed at end of study, T1 (2 weeks)
Mental health literacy
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.
Measured: Change between T0 and T1 (2 weeks)
Secondary outcomes (5)
PHQ-9 completion
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.
Measured: Assessed at T0 and at 2 weeks (T1)
Treatment initiation
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.
Measured: Assessed at end of study, T1 (2 weeks)
Treatment adherence
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.
Measured: Assessed at end of study, T1 (2 weeks)
Decisional regret
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.
Measured: Assessed at end of study, T1 (2 weeks)
Symptom monitoring - PHQ-9
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.
Measured: Change across 2 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lisa A. Mistler, Dartmouth-Hitchcock Medical Center
- Investigators
- Lisa A Mistler, MD, Principal investigator, Dartmouth-Hitchcock Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631247
- Sponsor's protocol ID
- STUDY02003455
- Other IDs
- R03AG088962-01
- Acronym
- care partners
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Screening and Access to Treatment for Depression in Care Partners of People Living With Dementia
- ClinicalTrials.gov ID
- NCT07631247
- Acronym / sponsor ID
- care partners / STUDY02003455
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- depression, caregiver, AD/ADRD, Alzheimer's disease, dementia, care partner, app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iPath*CP app intervention arm | Experimental | Other: depression app for care partners of persons with dementiaCare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For 2 Week iPath*CP Pilot:
- 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.
Key exclusion criteria (9 listed)
- Care partners with:
- Patients: Participants withdrawn from the 2 Week iPath*CP Pilot.
- Clinicians: None.
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 |
|---|---|---|
| depression app for care partners of persons with dementiaiPath*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. | Other | iPath*CP app intervention arm |
Primary outcome
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.
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.
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.
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.
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
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.
5 secondary outcomes
PHQ-9 completion
Time frame: Assessed at T0 and at 2 weeks (T1)
Treatment initiation
Time frame: Assessed at end of study, T1 (2 weeks)
Treatment adherence
Time frame: Assessed at end of study, T1 (2 weeks)
Decisional regret
Time frame: Assessed at end of study, T1 (2 weeks)
Symptom monitoring - PHQ-9
Time frame: Change across 2 week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lisa A Mistler, MD principal investigator
Dartmouth-Hitchcock Health
Questions about this trial
What is this clinical trial studying?
A study testing depression app for care partners of persons with dementia in people with Depression - Major Depressive Disorder, run by Dartmouth-Hitchcock Medical Center.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa A Mistler, MD (603-731-4422, lisa.a.mistler@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of Intervention (time frame: Assessed after initial use of iPath app at T1 (2 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.