Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders

The primary goals of our 3-year, 2-phase project are to develop AIM for primary care linkage
and assess its feasibility and acceptability. This protocol description only pertains to Part
A (treatment development) and B (open trial).

As it is essential that AIM is eventually implementable in practice settings, we integrate
implementation methods in our early development work. We will develop AIM to meet an existing
need (low-intensity anxiety disorder treatment), ensure that it fits our local setting, and
identify eventual implementation barriers and facilitators via an open pilot trial. We will
strive to develop and pilot AIM in a manner that is perceived as compatible with existing
practices, simple to use, advantageous relative to existing practice, and beneficial. In
order to conduct ongoing evaluation, a team of "end users," including Primary Care Physicians
(PCPs), nurses, patients and practice leaders at the Family Care Center (FCC) of Memorial
Hospital of Rhode Island, our study site, and at other sites in Rhode Island and
Massachusetts, will participate on an Advisory Panel (AP).

Part A: develop AIM including a: 1) personalization computer program that will create an
idiographic stimulus set for each participant to be used in the treatment; 2)
self-administered, personalized, Cognitive Bias Modification treatment; and 3) protocol for
primary care linked delivery.

Part B: an open trial of AIM comprising 3 iterations of 6 patients each. After each
iteration, our study team and the AP will review data on feasibility and acceptability of AIM
and delivery methods, and make revisions as needed. 8 primary care patients with primary
Generalized Anxiety Disorder, Social Anxiety Disorder, and/or Panic Disorder (with or without
Agoraphobia) will be enrolled, in 3 iterations. Full assessments will occur pre- and
post-treatment. Weekly measures of anxiety and depression will be collected, as will feedback
from patients and PCPs about the research and delivery procedures. At the end of the 1st
iteration (n=6), the research team and AP will discuss and compare our actual data to the
target outcomes. Target outcomes were chosen on face validity, clinical experience, and, when
available, relevant literature (e.g., efficacy target based on previous trials and what we
deemed clinically meaningful change for low-intensity treatment). Deviations from target
outcomes will prompt investigation and discussion, and possible revision of AIM or of
research procedures. After revision, we will recruit 6 new patients for the 2nd iteration. At
the end of this iteration, the team and AP will review data and make changes as needed. We
will repeat this process in the 3rd iteration (n=6).

Part C will include a randomized controlled trial of the final protocol.

Inclusion Criteria:

- Study site patient

- Age ≥18

- Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or
panic disorder with or without agoraphobia (PD/A)

- At least moderate anxiety severity (GAD-7 score > 10)

- English-speaking

- If on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects,
patients taking benzodiazepines will complete AIM prior to their first dose of the day

- No current psychotherapy

- No current severe psychiatric symptoms requiring immediate attention (e.g., imminent
suicidality, psychosis)