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

Phase 2

Completed

Conditions: Anxiety

Interventions: Behavioral: Cognitive Bias Modification - Interpretation training
Behavioral: Online psychoeducation about anxiety
Behavioral: Coaching

Registration Number: NCT03498651

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1748

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CBM-I, high attrition, coach	Cognitive Bias Modification - Interpretation training	Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
CBM-I, high attrition, coach	Coaching	Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
CBM-I, high attrition, no coach	Cognitive Bias Modification - Interpretation training	Computer- or phone-based Cognitive Bias Modification - Interpretation training
CBM-I, low attrition	Cognitive Bias Modification - Interpretation training	Computer- or phone-based Cognitive Bias Modification - Interpretation training
Psychoeducation	Online psychoeducation about anxiety	Online psychoeducation about anxiety

Primary Outcome Measures

Name	Time	Method
Change in Recognition Ratings (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.	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.
Change in Recognition Ratings (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.	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.
Change in Brief Bodily Sensations Interpretations Questionnaire (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.	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.
Change in Brief Bodily Sensations Interpretations Questionnaire (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.	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.
Change in Overall Anxiety Severity and Impairment Scale	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 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale	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 (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.

Secondary Outcome Measures

Name	Time	Method
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.	The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day.
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.	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. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
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.	Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way.
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.	Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think.
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.	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 aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items.
Change in Wellness Measures - Life Satisfaction	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. Participants are asked "All things considered, how satisfied are you with your life as a whole?" and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility	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. Participants are asked "I often look at a situation from different viewpoints." with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Change in Mechanisms Underlying Bias Change - Experiential Avoidance	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. Participants are asked "I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them." with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal	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. Participants are given two statements - "When I want to feel more positive emotion, I change the way I'm thinking about the situation" and "When I want to feel less negative emotion, I change the way I'm thinking about the situation" - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below.
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty	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.
Change in Anxiety and Identity Circles	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. Participants are asked "To what extent is your anxiety a central part of who you are currently?" and provided with 5 images of two circles, one labeled "My Anxiety" and one labeled "Me", where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety.