Web-based Interpretation Training For Anxiety
Testing Target Engagement and Effectiveness of Web-based Interpretation Training For Anxiety
1 other identifier
interventional
807
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 anxiety
Started Apr 2016
Typical duration for phase_2 anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
February 20, 2025
CompletedFebruary 20, 2025
January 1, 2025
2.8 years
February 16, 2015
August 9, 2023
January 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Recognition Ratings (Positive Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 2 disambiguated interpretations of the scenario: 1 positive and 1 negative. Participants will rate each disambiguated interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
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.
Change in Overall Anxiety Severity and Impairment Scale
The Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Hami Cissell, Means-Christensen, \& Stein, 2006) assesses anxiety frequency, severity, and associated avoidance, work and social interference. This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. All items are rated on a scale of 0 (lowest impairment/severity) to 4 (highest impairment/severity). Total scores on the OASIS are calculated by summing the scores of each of the 5 questions. The total score on the OASIS ranges from 0 to 20, with higher scores indicating greater anxiety. A cut-score of 8 or higher on the OASIS is considered to indicate probable anxiety disorder.
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.
Change in Recognition Ratings (Negative Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 2 disambiguated interpretations of the scenario: 1 positive and 1 negative. Participants will rate each disambiguated interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
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.
Change in Brief Bodily Sensations Interpretations Questionnaire
The Brief Bodily Sensation Interpretation Questionnaire (BBSIQ; Clark et al., 1997) was administered as a more independent, additional measure of interpretation bias. In the BBSIQ, participants are presented with fourteen ambiguous events related to physical (e.g., feeling lightheaded) or external (e.g., smelling smoke, social situations) concerns, along with three possible explanations for each ambiguous event (one negative, and two neutral or positive explanations). Participants rated the extent to which they believed each explanation for why the ambiguous event occurred on a Likert scale from 0 ("not at all likely") to 4 ("extremely likely"). Typically, the BBSIQ is administered on an eight-point Likert scale, but a 0-4 scale was used to align with other rating scales in the study. Negative interpretation bias score was computed by averaging the likelihood ratings for all negative explanations (following Steinman \& Teachman, 2010, 2015).
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 (4)
Multi-Session User Experience Questionnaire
At 2-month follow-up
Impact of Anxious Imagery Prime (Change Over Time is Exploratory But Should Show Anxious/Neutral Prime Differences; e.g., in Subjective Distress)
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).
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Baseline, after session 8 (~4 weeks after baseline) & at 2-month follow-up.
Change in Quality of Life Scale
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.
Study Arms (6)
Positive Training+Anxious Imagery Prime
EXPERIMENTALPositive Cognitive Bias Modification - Interpretation training paired with a preceding Anxious Imagery Prime
Positive Training+Neutral Imagery Prime
EXPERIMENTALPositive Cognitive Bias Modification - Interpretation training paired with a preceding Neutral Imagery Prime
50/50 Training+Anxious Imagery Prime
ACTIVE COMPARATOR50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Anxious Imagery Prime
50/50 Training+Neutral Imagery Prime
ACTIVE COMPARATOR50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Neutral Imagery Prime
No Scenario+Anxious Imagery Prime
OTHERNo scenarios paired with a preceding Anxious Imagery Prime
No Scenario+Neutral Imagery Prime
OTHERNo scenarios paired with a preceding Neutral Imagery Prime
Interventions
Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will then assign a benign (rather than threatening) meaning to the scenario.
This condition follows the same design and content as the Positive Training conditions, except the word fragments differ; rather than consistently resolving the scenario in a positive direction, half of the scenarios will end with a negative (anxiety-congruent) word fragment, and half will end with a positive word fragment.
We will test whether priming anxious concerns and feared negative outcomes on the web via the addition of a guided anxious imagery prime at the start of each session will enhance effects.
At the start of each session, participants will complete a neutral control imagery exercise where they do a guided imagery exercise imagining upcoming mundane tasks, like brushing one's teeth.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None listed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia)
Charlottesville, Virginia, 22904, United States
Related Publications (1)
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.
PMID: 31650889DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Bethany Teachman
- Organization
- University of Virginia Department of Psychology
Study Officials
- PRINCIPAL INVESTIGATOR
Bethany Teachman, PhD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Psychology
Study Record Dates
First Submitted
February 16, 2015
First Posted
March 6, 2015
Study Start
April 1, 2016
Primary Completion
January 1, 2019
Study Completion
March 1, 2019
Last Updated
February 20, 2025
Results First Posted
February 20, 2025
Record last verified: 2025-01