iPath for CP Pilot

NCT07631247 | Not Yet Recruiting

• 2 other identifiers: STUDY02003455R03AG088962-01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Depression - Major Depressive Disorder

Keywords

depression; caregiver; AD/ADRD; Alzheimer's disease; dementia; care partner; app

Outcome Measures

Primary Outcomes (6)

• Usability of Intervention

  System Usability Scale (10 items; mean ≥68/100)

  Assessed after initial use of iPath app at T1 (2 weeks)

• Acceptability of Intervention

  Acceptability of Intervention Measure (4 items).

  Assessed at end of study, T1 (2 weeks)

• Feasibility of Intervention

  Feasibility of Intervention Measure (4 items)

  Assessed at end of study, T1 (2 weeks)

• Appropriateness of Intervention

  Appropriateness of Intervention Measure (4 items)

  Assessed at end of study, T1 (2 weeks)

• Treatment access

  Proportion of patients selecting a treatment path to access e.g., click on link to access online treatment service \| indicate in self-report survey accessing local resources

  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

  Change between T0 and T1 (2 weeks)

Secondary Outcomes (5)

• PHQ-9 completion

  Assessed at T0 and at 2 weeks (T1)

• Treatment initiation

  Assessed at end of study, T1 (2 weeks)

• Treatment adherence

  Assessed at end of study, T1 (2 weeks)

• Decisional regret

  Assessed at end of study, T1 (2 weeks)

• Symptom monitoring - PHQ-9

  Change across 2 week period

Study Arms (1)

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.

Other: depression app for care partners of persons with dementia

Interventions

depression app for care partners of persons with dementia OTHER

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.

iPath*CP app intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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• Patients: Participants withdrawn from the 2 Week iPath\*CP Pilot.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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Depression; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lisa A Mistler, MD

  Dartmouth-Hitchcock Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Mistler, MD

CONTACT

603-731-4422; lisa.a.mistler@hitchcock.org

Susan Tarczewski, CCRP

CONTACT

603-646-7066; susan.m.tarczewski@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06