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

NCT03498651 | Completed Phase 2 Results DMC

• 1 other identifier: 2017-0234-00
• Study Type: interventional
• Target: 1,748
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

Anxiety; Cognitive bias; Telemedicine

Outcome Measures

Primary Outcomes (6)

• 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 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each 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 session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• 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 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each 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 session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)

  To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)

  To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Overall Anxiety Severity and Impairment Scale

  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. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.

  Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session.

• Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale

  This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

Secondary Outcomes (11)

• Change in Depression Comorbid Symptoms

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Alcohol Use Comorbid Symptoms

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Wellness Measures - Optimism

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Wellness Measures - Growth Mindset

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

• Change in Wellness Measures - Self-efficacy

  Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.

Study Arms (4)

CBM-I, low attrition

EXPERIMENTAL

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Behavioral: Cognitive Bias Modification - Interpretation training

CBM-I, high attrition, coach

EXPERIMENTAL

Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching

Behavioral: Cognitive Bias Modification - Interpretation training; Behavioral: Coaching

CBM-I, high attrition, no coach

EXPERIMENTAL

Computer- or phone-based Cognitive Bias Modification - Interpretation training

Behavioral: Cognitive Bias Modification - Interpretation training

Psychoeducation

ACTIVE COMPARATOR

Online psychoeducation about anxiety

Behavioral: Online psychoeducation about anxiety

Interventions

Cognitive Bias Modification - Interpretation training BEHAVIORAL

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 typically then assign a benign (rather than threatening) meaning to the scenario.

CBM-I, high attrition, coach; CBM-I, high attrition, no coach; CBM-I, low attrition

Coaching BEHAVIORAL

Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.

CBM-I, high attrition, coach

Online psychoeducation about anxiety BEHAVIORAL

Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia)

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• Eberle JW, Daniel KE, Baee S, Silverman AL, Lewis E, Baglione AN, Werntz A, French NJ, Ji JL, Hohensee N, Tong X, Huband JM, Boukhechba M, Funk DH, Barnes LE, Teachman BA. Web-based interpretation bias training to reduce anxiety: A sequential, multiple-assignment randomized trial. J Consult Clin Psychol. 2024 Jun;92(6):367-384. doi: 10.1037/ccp0000896.

  PMID: 39023984 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr. Bethany Teachman
• Organization: University of Virginia Department of Psychology

bethanyteachman@gmail.com

434-924-0676

Study Officials

• Bethany Teachman, PhD

  Univ. of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will be aware whether they are completing the intervention by phone or computer, and will know if they are receiving coaching or not.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 17, 2018
• Study Start: January 20, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared within one year of completion of the main trial.
• Access Criteria: We will follow the standard access criteria for the NIMH Data Archive.

Locations

US (1)