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

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ClinicalTrials.gov Identifier: NCT03498651
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bethany A. Teachman, Ph.D., University of Virginia

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Cognitive Bias Modification - Interpretation training Behavioral: Coaching Behavioral: Online psychoeducation about anxiety Phase 2

Detailed Description:
Approximately 25-30% of the U.S. population will experience anxiety pathology severe enough to qualify for an anxiety disorder diagnosis during their lifetime. Critically, the majority will not receive treatment, creating a serious need to consider alternative approaches to delivering mental health services that can meet needs on a larger scale. Cognitive Bias Modification (CBM) interventions for anxiety hold considerable promise as a way to meet these needs. These programs alter biased ways of thinking, such as selective assignment of threat interpretations, which are known to cause and maintain anxiety. CBM for interpretation bias (CBM-I) has established efficacy when administered via computer in the laboratory, and there is clear evidence for target engagement (i.e., change in interpretations, the identified mechanism). Now, effectiveness needs to be tested in the community, using sufficiently large samples to evaluate key moderators of its effects, including delivery method (computer vs. mobile phone) and the addition of minimal human contact (for those at risk of attrition). Addressing attrition is critical given high rates of drop out for web-based interventions. Via the PI's MindTrails web site (established with the lab's prior NIMH R34MH106770 award), the lab already has the infrastructure to deliver CBM to the public and recruit large anxious samples. Moreover, the PI and Co-I have established infrastructure to do mobile sensing of mood and CBM-I delivery via mobile phones. Thus, the project can respond to NIMH's request for "Effectiveness trials that can contribute to advancing the personalization of mental health care." The current proposal 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. Study 1 will provide a pilot feasibility and user experience test of the CBM-I program on mobile phones. Study 2 will examine the lab's current online, computer-based CBM-I data to help determine empirical indicators of attrition. Study 3 will provide the primary test of moderators of effectiveness. Namely, in Study 3, high anxious participants will be randomized to one of 2 conditions: 1) CBM-I training delivered by computer or mobile phone (at existing MindTrails site); 2) Alternate intervention group-Psychoeducation only. CBM-I and Psychoeducation conditions include 5 weekly training sessions. Based on theoretically- and empirically-derived predictors of attrition, participants identified as high-risk for dropout in condition 1 will then be randomly assigned to add minimal human contact (using a modified TeleCoach protocol) or no change. Using this adaptive intervention, known as Sequential, Multiple Assignment, Randomized Trial (SMART), the project can test both the effects of CBM-I delivery method and the added value of human contact to improve retention for participants at high-risk for dropping out.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Masking Description: Participants will be aware whether they are completing the intervention by phone or computer, and will know if they are receiving coaching or not.
Primary Purpose: Treatment
Official Title: Effectiveness of Interpretation of Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: CBM-I, low attrition
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Behavioral: Cognitive Bias Modification - Interpretation training
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.

Experimental: CBM-I, high attrition, coach
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Behavioral: Cognitive Bias Modification - Interpretation training
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.

Behavioral: Coaching
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.

Experimental: CBM-I, high attrition, no coach
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Behavioral: Cognitive Bias Modification - Interpretation training
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.

Active Comparator: Psychoeducation
Online psychoeducation about anxiety
Behavioral: Online psychoeducation about anxiety
Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.




Primary Outcome Measures :
  1. Change in Recognition Ratings [ Time Frame: 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. ]
    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.

  2. Change in Overall Anxiety Severity and Impairment Scale [ Time Frame: 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. ]
    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. Total scale range = 0-20, with a higher score indicating more severe anxiety.

  3. Change in Brief Bodily Sensations Interpretations Questionnaire [ Time Frame: 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. ]
    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. One option is always negative, whereas the other responses are either neutral and/or positive.

  4. Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale [ Time Frame: 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. ]
    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. Total DASS-21 subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe depression symptoms.


Secondary Outcome Measures :
  1. Change in Depression Comorbid symptoms [ Time Frame: 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. ]
    The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia.

  2. Change in Alcohol Use Comorbid symptoms [ Time Frame: 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. ]
    The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders.

  3. Change in Wellness measures - Optimism [ Time Frame: 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. ]
    Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) will assess generalized optimism versus pessimism.

  4. Change in Wellness measures - Growth mindset [ Time Frame: 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. ]
    Items 1, 5, and 7 from the Growth Mindset Measure will be administered to measure changes in thinking styles (altered from the original items that reference intelligence).

  5. Change in Wellness measures - Self-efficacy [ Time Frame: 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. ]
    Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total range for aggregated 3 items = 0-12, with a higher score indicating more self-efficacy.

  6. Change in Wellness measures - Life Satisfaction [ Time Frame: 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. ]
    Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life.

  7. Change in Mechanisms underlying bias change - Cognitive flexibility [ Time Frame: 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. ]
    Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility.

  8. Change in Mechanisms underlying bias change - Experiential avoidance [ Time Frame: 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. ]
    Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance.

  9. Change in Mechanisms underlying bias change - Cognitive reappraisal [ Time Frame: 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. ]
    Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal.

  10. Change in Mechanisms underlying bias change - Intolerance of uncertainty [ Time Frame: 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. ]
    Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty.

  11. Change in Anxiety and Identity Circles [ Time Frame: 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. ]
    We will assess change in the extent anxiety is viewed as central to the person's self-concept.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498651


Contacts
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Contact: Bethany Teachman, PhD 4349240676 bat5x@virginia.edu

Locations
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United States, Virginia
MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia) Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Bethany Teachman, PhD    434-924-0676    bat5x@virginia.edu   
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Bethany Teachman, PhD Univ. of Virginia

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Responsible Party: Bethany A. Teachman, Ph.D., Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03498651     History of Changes
Other Study ID Numbers: 2017-0234-00
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared on the NIMH Data Archive.
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.
URL: https://data-archive.nimh.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bethany A. Teachman, Ph.D., University of Virginia:
Anxiety
Cognitive bias
Telemedicine

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders