Clinical trial NCT02382003: Web-based Interpretation Training For Anxiety
Official title: Testing Target Engagement and Effectiveness of Web-based Interpretation Training For Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety
Keywords: Anxiety
Cognitive bias
Telemedicine
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to develop a web-based Cognitive Bias Modification infrastructure to train interpretations, and evaluate the usability, acceptability, and feasibility of the program to reduce anxiety symptoms.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Recognition Ratings (Positive Interpretation Bias)
timeFrame: Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.
measure: Change in Overall Anxiety Severity and Impairment Scale
timeFrame: Baseline, and after sessions 1,2,3,4,5,6,7,8 (sessions will be spaced ~3-4 days apart) & at 2-month follow-up. Measure will be completed immediately following that day's training session. Session 2 is expected to occur within 3-8 days of the baseline.
measure: Change in Recognition Ratings (Negative Interpretation Bias)
timeFrame: Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.
measure: Change in Brief Bodily Sensations Interpretations Questionnaire
timeFrame: Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.
Secondary outcomes:
measure: Multi-Session User Experience Questionnaire
timeFrame: At 2-month follow-up
measure: Impact of Anxious Imagery Prime (Change Over Time is Exploratory But Should Show Anxious/Neutral Prime Differences; e.g., in Subjective Distress)
timeFrame: After sessions 1,2,3,4,5,6,7,8 (sessions will be spaced ~3-4 days apart). Measure will be completed following that day's imagery prime (which immediately precedes the training session).
measure: Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
timeFrame: Baseline, after session 8 (~4 weeks after baseline) & at 2-month follow-up.
measure: Change in Quality of Life Scale
timeFrame: Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia)
state: Virginia
Study officials:
affiliation: University of Virginia
name: Bethany Teachman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinman SA, Portnow S, Billingsley AL, Zhang D, Teachman BA. Threat and benign interpretation bias might not be a unidimensional construct. Cogn Emot. 2020 Jun;34(4):783-792. doi: 10.1080/02699931.2019.1682973. Epub 2019 Oct 25.