Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
Phase: NA
Conditions: Anxiety Disorders
Sponsor: Brown University

 
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Study Protocol 
 
 Study Title:  
Developing a Low-Intensity, Primary Care Intervention 
for Anxiety Disorders 
 
Date: 7/17/2017 
 
NCT#: NCT02579915  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Title of Research Project:  Developing a Low-Intensity, Primary Care Intervention for Anxiety 
Disorders 
 
 
Overall Protocol Summary: 
 
 
Primary care patients with anxiety disorders (ADs) have worse functioning, poorer outcome of 
their medical illnesses, and are among the greatest users of primary care resources. There is a strong need 
for scalable treatments. Low-intensity, computerized treatments may be particularly implementable, as 
they may require less professional assistance and have a broader reach than face-to-face or even telehealth 
treatments. Low-intensity treatments are suited for delivery linked to primary care, as this setting has a 
great unmet need, is often the first access point for treatment, and allows for monitoring by a physician. 
 
Cognitive Bias Modification is a promising intervention for ADs that may be ideally suited for 
primary care settings. CBM directly targets cognitive processes (i.e., attention and interpretation biases) 
underlying ADs. The current study will develop a personalized CBM program called Face Anxiety 
(formerly referred to as AIM), comprising 8, 30-minute computer sessions. In these sessions, participants 
practice disengaging their attention from threatening stimuli and interpreting ambiguous social scenarios 
in a benign manner.  
 
The primary goals of our 3-year, 2-phase project are to develop Face Anxiety for primary care 
linkage and assess its feasibility, acceptability, and efficacy. We integrate implementation methods in our 
early development work. In order to conduct ongoing evaluation, a team of “end users,” including 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, have agreed to participate on 
an Advisory Panel (AP).  
 
Phase 1 has 2 parts.  
Part A: develop Face Anxiety 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, CBM treatment; and 3) protocol for primary care linked delivery.  
Part B: an open trial of Face Anxiety comprising 3 iterations of 6 patients each. After each iteration, our 
study team and the AP will review data on feasibility and acceptability of Face Anxiety and delivery 
methods, and make revisions as needed 
 
Phase 2 goals are to refine and pilot the intervention, with input from relevant groups. With 
continued AP feedback, we will pilot an RCT of Face Anxiety vs. control to further refine the program 
and delivery methods, and further assess their feasibility /acceptability along with that of our RCT 
research protocol. 
 
Phase 1 A was approved by the IRB 4/1/14 (14-10).   
Phase 1 B was approved by the IRB 9/2/14 
Phase 2 was approved by the IRB 9/25/15 
 
 
As stated above, Phase 1B is an open trial of Face Anxiety comprising a total of 18 patients. (3 
iterations of 6 patients each). In Phase 1B, interested participants, who give informed consent, will 
participate in a 5-minute screening interview. Potentially eligible participants will then complete the 
full open trial consent form and complete a pre-treatment/eligibility assessment. All eligible participants 
will then complete 8, bi-weekly computer intervention sessions (Please see Appendix for a detailed 
description of the Face Anxiety program). The first session will occur in the primary clinic, with 
assistance by study staff, to assure participant’s familiarity with using the on-line program. After 
completion of the first session in the primary care clinic, participants will be permitted to choose to 
complete the remaining sessions at home, or in the clinic. Participants will have flexibility in scheduling 
at home sessions, as long as they complete no more than two sessions per week. Participants 

 
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completing sessions in the clinic will be asked to book a time, to assure that a computer is available to 
them. The study will provide laptop computers for use in the clinic.  Participants will be asked to make 
up any missed sessions, so that all participants would ideally complete 8 sessions. All sessions must be 
completed within 6 weeks.  All participants will complete pre- and post-program assessments of 
anxiety, depression, quality of life, treatment satisfaction, and cognitive biases. All participants will 
also complete weekly measures of anxiety and depression. [See attached list of assessments] After 
completion of the post-program assessment, participants will complete a qualitative interview to obtain 
feedback about acceptability, perceived helpfulness, and suggestions for improvement. 
 
Phase 2 is a randomized controlled trial comparing Face Anxiety to a symptom tracking control 
condition comprising a total of 42 patients. The eligibility criteria, screening and consent process, 
assessments, and safety monitoring are identical to those approved for Phase 1B.  
As in Phase 1B, in Phase 2, interested participants, who give informed consent, will participate in a 5-
minute screening interview. Potentially eligible participants will then complete the full randomized trial 
consent form and complete a pre-treatment/eligibility assessment. All eligible participants will then be 
randomized to complete either the 8, bi-weekly computer intervention sessions (Please see Appendix 
for a detailed description of the Face Anxiety program) or a symptom tracking control.  
 
Face Anxiety – Mental Habits Program. 
This arm of the RCT will function exactly as did the already IRB approved and currently running Open 
Trial.  (see description of Phase 1B above)  
 
Face Anxiety - Symptom Tracking Program. 
This arm of the RCT is new since the open trial and will serve as the control group in the RCT. In Face 
Anxiety – Symptom Tracking, participants will complete weekly symptom assessments in the same 
manner as proposed for all participants in the IRB approved Open Trial proposal – via self-report.  
Specifically, each week the Face Anxiety Specialist will contact participants with information on how to 
complete the symptom questionnaires. This will typically occur by emailing participants a computer link 
to their surveys, which can be accessed on a website using SSL encryption (see details below). 
Participants will be informed of the risks associated with unencrypted email in the consent form. In the 
event a participant does not have internet access at home, they will be offered the opportunity to complete 
the symptom measures on a computer in the clinic, or, if necessary, over the phone with the Face Anxiety 
Specialist. These assessments will be conducted, in part, as a means of continuing to monitor patient 
safety and potential clinical deterioration. Further though, they would be conducted to provide patients 
and their PCPs with feedback regarding any patients’ deterioration so that the PCP may then choose to 
use to adjust the patient’s care.  Similar to the Mental Habits condition, participants in this condition will 
be given a credible treatment rationale regarding the benefits of regular self-monitoring and feedback. 
This symptom tracking control group would permit us to answer a crucial question for the future success 
of implementing FaceAnxiety:  Does our low-intensity intervention add any benefit beyond what patients 
might more commonly be offered in primary care settings (medication, and possibly very brief onsite 
behavioral health services).  
 
A study staff member will serve as the “FaceAnxiety Specialist” (FAS) who will check in with 
participants once a week during the 4 weeks that they are completing the Face Anxiety sessions to 
answer any questions, monitor participants’ progress, and communicate participants’ progress to their 
physician via the Electronic Medical Record (EMR) and/or personal contact. Specifically, the FAS will 
review patients’ responses to the GAD-7 and PHQ-9 (see Measures and Protection Against Risk 
sections), as well as their completion (or lack thereof) of the computer tasks. If patients are having 
difficulty completing the program, the FAS will help them troubleshoot technical problems.  
 
Additionally, if a patient has a diagnosis of PTSD, the FAS will administer the PCL-C on a weekly 

 
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basis to monitor PTSD symptoms (see Measures and Protection Against Risk sections). In the Face 
Anxiety – Mental Habits arm, the FAS will also discuss and address any difficulty the participant may 
be having with motivation to complete the program. If participants choose to complete the sessions at 
home, the FAS will offer to contact them by phone. If participants choose to complete the sessions in 
clinic, the FAS will be available to meet with them while they are in clinic. All meetings with the FAS 
will be audio-recorded.  
 
All participants will complete pre-program, mid-program, post-program, and 3-month-follow-up 
assessments of anxiety, depression, quality of life, treatment satisfaction, and cognitive biases. These 
assessment visits include a self-report packet of questionnaires, 4 computer tasks, and a qualitative 
interview (post-program only). An FAS will conduct the assessment visits, with the exception of the 
clinical interviews (SCID, HARS/CAS), which will be conducted by one of our blinded clinical 
assessors. Participants will also complete weekly measures of anxiety and depression. [See attached list 
of assessments] After completion of the post-program assessment, participants will complete a 
qualitative interview to obtain feedback about acceptability, perceived helpfulness, and suggestions for 
improvement. 
 
Statistical Analysis Plan 
Descriptive statistics will be calculated to examine our a priori benchmarks for feasibility, acceptability, 
safety, and preliminary efficacy.