iPath for CP Pilot
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
depression app for care partners of persons with dementia
Other interventioniPath\*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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: iPath*CP app intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed after initial use of iPath app at T1 (2 weeks)2
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.
Time frame
Assessed at end of study, T1 (2 weeks)3
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.
Time frame
Assessed at end of study, T1 (2 weeks)4
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.
Time frame
Assessed at end of study, T1 (2 weeks)Secondary outcomes
1
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.
Time frame
Assessed at T0 and at 2 weeks (T1)2
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.
Time frame
Assessed at end of study, T1 (2 weeks)3
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.
Time frame
Assessed at end of study, T1 (2 weeks)4
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.
Time frame
Assessed at end of study, T1 (2 weeks)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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