Phase 2 N=1,748 Randomized Single-blind Treatment

Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition

Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT03498651 ↗

Enrolled (actual)

1,748

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change in Recognition Ratings (Positive Interpretation Bias) — 2.40; 2.29; 2.29; 2.30 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cognitive Bias Modification - Interpretation training (Behavioral); Coaching (Behavioral); Online psychoeducation about anxiety (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Recognition Ratings (Positive Interpretation Bias)	2.40; 2.29; 2.29; 2.30; 2.33; 2.40	—
PRIMARY Change in Recognition Ratings (Negative Interpretation Bias)	2.78; 2.90; 2.96; 2.94; 2.89; 2.70	—
PRIMARY Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)	2.04; 2.00; 2.13; 2.05; 2.07; 2.23	—
PRIMARY Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)	1.42; 1.61; 1.52; 1.58; 1.61; 1.35	—
PRIMARY Change in Overall Anxiety Severity and Impairment Scale	2.28; 2.32; 2.31; 2.34; 2.31; 2.62	—
PRIMARY Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale	1.61; 1.58; 1.65; 1.65; 1.65; 1.71	—
SECONDARY Change in Depression Comorbid Symptoms	2.77; 2.76; 2.68; 2.77; 2.78; 2.92	—
SECONDARY Change in Alcohol Use Comorbid Symptoms	0.92; 0.90; 0.94; 0.95; 0.90; 0.64	—
SECONDARY Change in Wellness Measures - Optimism	1.33; 1.40; 1.39; 1.45; 1.29; 1.85	—
SECONDARY Change in Wellness Measures - Growth Mindset	2.17; 2.14; 2.12; 2.10; 2.13; 2.13	—
SECONDARY Change in Wellness Measures - Self-efficacy	2.27; 2.27; 2.37; 2.22; 2.20; 2.15	—
SECONDARY Change in Wellness Measures - Life Satisfaction	4.71; 4.77; 5.09; 4.95; 5.01; 4.31	—
SECONDARY Change in Mechanisms Underlying Bias Change - Cognitive Flexibility	5.20; 5.20; 5.25; 5.17; 5.04; 5.54	—
SECONDARY Change in Mechanisms Underlying Bias Change - Experiential Avoidance	4.05; 3.78; 3.89; 3.85; 3.80; 3.85	—
SECONDARY Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal	4.41; 4.28; 4.34; 4.29; 4.14; 4.65	—
SECONDARY Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty	5.42; 5.57; 5.56; 5.65; 5.53; 5.62	—
SECONDARY Change in Anxiety and Identity Circles	2.48; 2.55; 2.51; 2.56; 2.49; 2.42	—

Summary

The project aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.

Eligibility Criteria

Inclusion Criteria

Age 18 and over
Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale
Regular access to the Internet via Smartphone or computer

Exclusion Criteria

None

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03498651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.