Web-based Interpretation Training For Anxiety

Approximately half of the U.S. population experiences serious mental health problems during
their lifetime, including 29% with anxiety pathology severe enough to qualify for an anxiety
disorder diagnosis [1]. Critically, more than two thirds of individuals struggling with a
mental illness do not receive treatment [1]. With this level of mental illness burden, it is
clear that treating people one-on-one in an office setting will never meet the existing needs
[2]. There are many barriers to treatment, including costs [3], difficulties accessing
evidence-based treatments in many regions [4], and associated stigma [5]. Thus, there is a
pressing need to consider alternative, larger scale approaches to delivering mental health
services. Cognitive Bias Modification (CBM) interventions hold considerable promise as a way
to meet these needs, especially for anxiety difficulties [6]. These computer-based programs
are designed to alter biased ways of thinking, such as a tendency toward negative
interpretations, which cause and maintain anxiety [6]. Because these programs do not require
therapist contact and can be administered on any computer with an Internet connection, CBM
holds promise as a cost-effective method that can be disseminated widely. However, while CBM
for interpretation bias (CBM-I) has established efficacy when administered in-person in the
laboratory [7], it now needs to be tested with broader populations using a web-based
infrastructure to examine: a) whether the program will be effective in a web environment, b)
whether the program continues to engage the targeted mechanism (i.e., interpretation bias),
c) the feasibility of this delivery method, and d) the modifications needed to adapt the
program for the web (in particular, to prime anxiety-linked negative thinking in an online
environment, we test the effect of adding a guided anxious imagery exercise to prime feared
outcomes prior to each training session).

Together, the current proposal will develop an infrastructure to pilot test the effectiveness
of web-based CBM-I for anxiety symptoms. CBM-I training will target moderate to severe
anxiety symptoms, a widespread problem area with considerable occupational and social
impairment [8]. Participants will be visitors to Project Implicit Mental Health (PIMH), an
existing website directed by the Principal Investigator that allows visitors to assess their
cognitive biases tied to mental health concerns. Consistent with the RFA's priorities, this
approach encourages efficiencies by capitalizing on the existing PIMH site and its heavy
traffic. Further, the site's large number of visitors and use of automated assessments will
make it efficient to assess baseline demographic characteristics and interpretation bias as
moderators of CBM-I effects that can be tested in future trials.

Aim 1: Develop and evaluate usability and acceptability of web-based CBM-I for anxiety
symptoms.

Aim 1 will build the web-based interpretation bias training program using the PIMH
infrastructure. We will pilot the program on a small test group of moderate to highly anxious
participants (N=15) who will complete questionnaires and semi-structured interviews to
provide feedback on the programs' usability and acceptability. Further, an advisory board
(N=8) of anxiety researchers, clinicians, and experts in CBM and web-based research will
provide feedback on the program and study protocol. Using a "deployment-focused" approach,
this feedback from experts and end-users will be used to iteratively modify the program for
the trial planned for Aims 2 and 3. Thus, even at this initial pilot stage, we will measure
the targeted outcome (anxiety symptoms) and mechanism (interpretation bias) to determine
whether modifications to enhance target engagement are needed. Note, within Research Domain
Criteria (RDoC), this outcome falls under the Potential Threat/Anxiety construct within the
Negative Valence System, and the targeted mechanism (interpretation bias) falls under the
Response Selection, Inhibition construct within the Cognitive (effortful) control system.
Both the outcome and mechanism will be objectively measured using multiple units of analysis
(e.g., behavior and self-report). Further, mechanisms underlying the guided anxious imagery
prime's effects will be measured by assessing subjective distress, imagery vividness, and
activation of feared outcomes following the manipulation. This prime was selected in part
because of its potential to be disseminated widely in future trials, given it does not
require human contact.

Aim 2: Test target engagement, feasibility and effectiveness of web-based CBM-I.

Aim 3: Evaluate the impact of an anxious prime on web-based CBM-I for anxiety symptoms.

Aims 2 and 3 will test the feasibility of an 8-session web-based interpretation training
program among individuals with moderate to severe anxiety symptoms (based on screening at the
PIMH site). Participants will be randomly assigned to positive CBM-I (90% positive scenario
training), 50% positive/50% negative CBM-I, or a no scenario control condition. Half the
participants in each of these 3 conditions will receive an anxious imagery prime prior to
each training session, and half will receive a neutral imagery prime, resulting in a 3
training condition x 2 prime design (N=210; target of n=35 per condition). Feasibility will
be determined by analyses of recruitment, attrition, acceptance of randomization, adherence
to and appropriateness of the measurement model, caseness, extent of missing data, and
safety. Additionally, target engagement (change in interpretation bias) and preliminary tests
of effectiveness at reducing anxiety symptoms will be evaluated.

Inclusion Criteria:

The target population will be adults age 18 and over who score in the moderate to extremely
severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short
Form: Anxiety Subscale and have regular access to the Internet.

Exclusion Criteria:

None listed.