Clinical trial NCT04689568: Improving Depression Via E-Health Access (IDEA) Study
Official title: Improving Depression Via E-Health Access (IDEA) Study: Evaluating Uptake and Efficacy of Self-Help e-Mental Health Interventions in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, non-randomized, preferred assignment study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. The researchers would also like to know how likely someone is to use the resources and their satisfaction with the resources.

Detailed description: Participants will be using a self-help resource for the 6-week study period. A Care Manager will contact participants by phone, once a week, for about 5-10 minutes at a pre-arranged time. Participation will be needed for 10 weeks in total (6 weeks of active participation and a survey 1-month after the study intervention ends).

Subscription-based self-help resources being tested during the study will not be freely available after the study period. However, the researchers will share information on how to access these resources for a fee after the study period to all participants.

In addition to the time above, the researchers will collect information from participant's medical records for another 10 months after participation. The entire study is expected to last about 2 years.

Eligibility criteria: Inclusion Criteria:

* Individuals who are English-speaking
* Individuals with a Patient Health Questionnaire 9 (PHQ9) score greater than or equal to 11 or diagnosis of moderate to severe depression determined by the Care Manager during her initial psychiatric evaluation and by the study PI during panel review will supersede a low PHQ9 score.
* Individuals with have daily internet access and a smartphone;
* Individuals who agree to periodic contact with the care manager and study team.

Exclusion Criteria:

* Individuals who have cognitive impairment that would preclude use of self-help resources
* Individuals with already using an electronic mental health resource;
* Individuals with unstable medical illness, e.g. active cancer;
* Individuals with severe psychiatric symptoms (marked suicidality, psychotic symptoms, severe substance abuse)

Primary outcomes:
measure: Patient preference, use and satisfaction of the intervention as assessed by timed structured survey
timeFrame: Up to 14 months
measure: Patient frequency and duration of intervention use and satisfaction as assessed by weekly structured survey
timeFrame: Up to 14 months
measure: Patient preference and satisfaction with the intervention as assessed by qualitative interviews
timeFrame: Up to approximately 14 months
measure: Care manager experiences of the intervention as assessed by qualitative interviews
timeFrame: Up to approximately 18 months
measure: Clinician/Administrator views related to interventions as assessed by qualitative interviews
timeFrame: Up to approximately 18 months
measure: Patient frequency of intervention use as assessed by self-report use of tools
timeFrame: Up to 14 months
measure: Change in severity of symptoms of depression as assessed with the Patient Health Questionnaire 9 (PHQ-9) score
timeFrame: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
measure: Change in level of functioning as assessed with the Sheehan Disability Scale (SDS)
timeFrame: At baseline (before choosing an intervention) and at week 6 (when they complete the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jennifer Severe, MD
role: PRINCIPAL_INVESTIGATOR
References: