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

Primary Purpose

Anxiety

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive Bias Modification - Interpretation training
Coaching
Online psychoeducation about anxiety
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Cognitive bias, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

CBM-I, low attrition

CBM-I, high attrition, coach

CBM-I, high attrition, no coach

Psychoeducation

Arm Description

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

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

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

Online psychoeducation about anxiety

Outcomes

Primary Outcome Measures

Change in Recognition Ratings
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.
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. Total scale range = 0-20, with a higher score indicating more severe anxiety.
Change in Brief Bodily Sensations Interpretations Questionnaire
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.
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. 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

Change in Depression Comorbid symptoms
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia.
Change in Alcohol Use Comorbid symptoms
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.
Change in Wellness measures - Optimism
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) will assess generalized optimism versus pessimism.
Change in Wellness measures - Growth mindset
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).
Change in Wellness measures - Self-efficacy
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.
Change in Wellness measures - Life Satisfaction
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life.
Change in Mechanisms underlying bias change - Cognitive flexibility
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility.
Change in Mechanisms underlying bias change - Experiential avoidance
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance.
Change in Mechanisms underlying bias change - Cognitive reappraisal
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal.
Change in Mechanisms underlying bias change - Intolerance of uncertainty
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.
Change in Anxiety and Identity Circles
We will assess change in the extent anxiety is viewed as central to the person's self-concept.

Full Information

First Posted
March 31, 2018
Last Updated
November 8, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03498651
Brief Title
Interpretation Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
Official Title
Effectiveness of Interpretation of Training to Reduce Anxiety: Evaluating Technology-based Delivery Models and Methods to Reduce Attrition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Cognitive bias, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
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.
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBM-I, low attrition
Arm Type
Experimental
Arm Description
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Arm Title
CBM-I, high attrition, coach
Arm Type
Experimental
Arm Description
Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Arm Title
CBM-I, high attrition, no coach
Arm Type
Experimental
Arm Description
Computer- or phone-based Cognitive Bias Modification - Interpretation training
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Online psychoeducation about anxiety
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Bias Modification - Interpretation training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online psychoeducation about anxiety
Intervention Description
Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
Primary Outcome Measure Information:
Title
Change in Recognition Ratings
Description
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.
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.
Title
Change in Overall Anxiety Severity and Impairment Scale
Description
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.
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.
Title
Change in Brief Bodily Sensations Interpretations Questionnaire
Description
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.
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.
Title
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Depression Comorbid symptoms
Description
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia.
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.
Title
Change in Alcohol Use Comorbid symptoms
Description
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.
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.
Title
Change in Wellness measures - Optimism
Description
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) will assess generalized optimism versus pessimism.
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.
Title
Change in Wellness measures - Growth mindset
Description
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).
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.
Title
Change in Wellness measures - Self-efficacy
Description
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.
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.
Title
Change in Wellness measures - Life Satisfaction
Description
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life.
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.
Title
Change in Mechanisms underlying bias change - Cognitive flexibility
Description
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure 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.
Title
Change in Mechanisms underlying bias change - Experiential avoidance
Description
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure 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.
Title
Change in Mechanisms underlying bias change - Cognitive reappraisal
Description
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure 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.
Title
Change in Mechanisms underlying bias change - Intolerance of uncertainty
Description
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.
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.
Title
Change in Anxiety and Identity Circles
Description
We will assess change in the extent anxiety is viewed as central to the person's self-concept.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bethany Teachman, PhD
Phone
4349240676
Email
bat5x@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Teachman, PhD
Organizational Affiliation
Univ. of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
MindTrails web site: https://mindtrails.virginia.edu/ (thru Univ. of Virginia)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bethany Teachman, PhD
Phone
434-924-0676
Email
bat5x@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared on the NIMH Data Archive.
IPD Sharing Time Frame
Data will be shared within one year of completion of the main trial.
IPD Sharing Access Criteria
We will follow the standard access criteria for the NIMH Data Archive.
IPD Sharing URL
https://data-archive.nimh.nih.gov/

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

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