Web-based Interpretation Training For Anxiety

Phase 2

Completed

Conditions: Anxiety

Interventions: Behavioral: Positive Cognitive Bias Modification - Interpretation
Behavioral: Neutral Imagery Prime
Behavioral: 50/50 Cognitive Bias Modification - Interpretation
Behavioral: Anxious Imagery Prime

Registration Number: NCT02382003

Lead Sponsor: University of Virginia

Brief Summary: The study aims to develop a web-based Cognitive Bias Modification infrastructure to train interpretations, and evaluate the usability, acceptability, and feasibility of the program to reduce anxiety symptoms.

Detailed Description: Approximately half of the U.S. population experiences serious mental health problems during their lifetime, including 29% with anxiety pathology severe enough to qualify for an anxiety disorder diagnosis \[1\]. Critically, more than two thirds of individuals struggling with a mental illness do not receive treatment \[1\]. With this level of mental illness burden, it is clear that treating people one-on-one in an office setting will never meet the existing needs \[2\]. There are many barriers to treatment, including costs \[3\], difficulties accessing evidence-based treatments in many regions \[4\], and associated stigma \[5\]. Thus, there is a pressing need to consider alternative, larger scale approaches to delivering mental health services. Cognitive Bias Modification (CBM) interventions hold considerable promise as a way to meet these needs, especially for anxiety difficulties \[6\]. These computer-based programs are designed to alter biased ways of thinking, such as a tendency toward negative interpretations, which cause and maintain anxiety \[6\]. Because these programs do not require therapist contact and can be administered on any computer with an Internet connection, CBM holds promise as a cost-effective method that can be disseminated widely. However, while CBM for interpretation bias (CBM-I) has established efficacy when administered in-person in the laboratory \[7\], it now needs to be tested with broader populations using a web-based infrastructure to examine: a) whether the program will be effective in a web environment, b) whether the program continues to engage the targeted mechanism (i.e., interpretation bias), c) the feasibility of this delivery method, and d) the modifications needed to adapt the program for the web (in particular, to prime anxiety-linked negative thinking in an online environment, we test the effect of adding a guided anxious imagery exercise to prime feared outcomes prior to each training session).

Together, the current proposal will develop an infrastructure to pilot test the effectiveness of web-based CBM-I for anxiety symptoms. CBM-I training will target moderate to severe anxiety symptoms, a widespread problem area with considerable occupational and social impairment \[8\]. Participants will be visitors to Project Implicit Mental Health (PIMH), an existing website directed by the Principal Investigator that allows visitors to assess their cognitive biases tied to mental health concerns. Consistent with the RFA's priorities, this approach encourages efficiencies by capitalizing on the existing PIMH site and its heavy traffic. Further, the site's large number of visitors and use of automated assessments will make it efficient to assess baseline demographic characteristics and interpretation bias as moderators of CBM-I effects that can be tested in future trials.

Aim 1: Develop and evaluate usability and acceptability of web-based CBM-I for anxiety symptoms.

Aim 1 will build the web-based interpretation bias training program using the PIMH infrastructure. We will pilot the program on a small test group of moderate to highly anxious participants (N=15) who will complete questionnaires and semi-structured interviews to provide feedback on the programs' usability and acceptability. Further, an advisory board (N=8) of anxiety researchers, clinicians, and experts in CBM and web-based research will provide feedback on the program and study protocol. Using a "deployment-focused" approach, this feedback from experts and end-users will be used to iteratively modify the program for the trial planned for Aims 2 and 3. Thus, even at this initial pilot stage, we will measure the targeted outcome (anxiety symptoms) and mechanism (interpretation bias) to determine whether modifications to enhance target engagement are needed. Note, within Research Domain Criteria (RDoC), this outcome falls under the Potential Threat/Anxiety construct within the Negative Valence System, and the targeted mechanism (interpretation bias) falls under the Response Selection, Inhibition construct within the Cognitive (effortful) control system. Both the outcome and mechanism will be objectively measured using multiple units of analysis (e.g., behavior and self-report). Further, mechanisms underlying the guided anxious imagery prime's effects will be measured by assessing subjective distress, imagery vividness, and activation of feared outcomes following the manipulation. This prime was selected in part because of its potential to be disseminated widely in future trials, given it does not require human contact.

Aim 2: Test target engagement, feasibility and effectiveness of web-based CBM-I.

Aim 3: Evaluate the impact of an anxious prime on web-based CBM-I for anxiety symptoms.

Aims 2 and 3 will test the feasibility of an 8-session web-based interpretation training program among individuals with moderate to severe anxiety symptoms (based on screening at the PIMH site). Participants will be randomly assigned to positive CBM-I (90% positive scenario training), 50% positive/50% negative CBM-I, or a no scenario control condition. Half the participants in each of these 3 conditions will receive an anxious imagery prime prior to each training session, and half will receive a neutral imagery prime, resulting in a 3 training condition x 2 prime design (N=210; target of n=35 per condition). Feasibility will be determined by analyses of recruitment, attrition, acceptance of randomization, adherence to and appropriateness of the measurement model, caseness, extent of missing data, and safety. Additionally, target engagement (change in interpretation bias) and preliminary tests of effectiveness at reducing anxiety symptoms will be evaluated.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 807

Inclusion Criteria

The target population will be adults age 18 and over who score in the moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale and have regular access to the Internet.

Exclusion Criteria

None listed.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Training+Neutral Imagery Prime	Positive Cognitive Bias Modification - Interpretation	Positive Cognitive Bias Modification - Interpretation training paired with a preceding Neutral Imagery Prime
Positive Training+Anxious Imagery Prime	Anxious Imagery Prime	Positive Cognitive Bias Modification - Interpretation training paired with a preceding Anxious Imagery Prime
No Scenario+Anxious Imagery Prime	Anxious Imagery Prime	No scenarios paired with a preceding Anxious Imagery Prime
No Scenario+Neutral Imagery Prime	Neutral Imagery Prime	No scenarios paired with a preceding Neutral Imagery Prime
50/50 Training+Anxious Imagery Prime	Anxious Imagery Prime	50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Anxious Imagery Prime
Positive Training+Anxious Imagery Prime	Positive Cognitive Bias Modification - Interpretation	Positive Cognitive Bias Modification - Interpretation training paired with a preceding Anxious Imagery Prime
50/50 Training+Neutral Imagery Prime	50/50 Cognitive Bias Modification - Interpretation	50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Neutral Imagery Prime
50/50 Training+Neutral Imagery Prime	Neutral Imagery Prime	50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Neutral Imagery Prime
Positive Training+Neutral Imagery Prime	Neutral Imagery Prime	Positive Cognitive Bias Modification - Interpretation training paired with a preceding Neutral Imagery Prime
50/50 Training+Anxious Imagery Prime	50/50 Cognitive Bias Modification - Interpretation	50/50 Cognitive Bias Modification - Interpretation (half positive \& half negative scenarios) paired with a preceding Anxious Imagery Prime

Primary Outcome Measures

Name	Time	Method
Change in Recognition Ratings (Positive Interpretation Bias)	Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. 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 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 Overall Anxiety Severity and Impairment Scale	Baseline, and after sessions 1,2,3,4,5,6,7,8 (sessions will be spaced ~3-4 days apart) & at 2-month follow-up. Measure will be completed immediately following that day's training session. Session 2 is expected to occur within 3-8 days of the baseline.	The Overall Anxiety Severity and Impairment Scale (OASIS; Norman, Hami Cissell, Means-Christensen, \& Stein, 2006) assesses anxiety frequency, severity, and associated avoidance, work and social interference. 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. All items are rated on a scale of 0 (lowest impairment/severity) to 4 (highest impairment/severity). Total scores on the OASIS are calculated by summing the scores of each of the 5 questions. The total score on the OASIS ranges from 0 to 20, with higher scores indicating greater anxiety. A cut-score of 8 or higher on the OASIS is considered to indicate probable anxiety disorder.
Change in Recognition Ratings (Negative Interpretation Bias)	Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. 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 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	Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.	The Brief Bodily Sensation Interpretation Questionnaire (BBSIQ; Clark et al., 1997) was administered as a more independent, additional measure of interpretation bias. In the BBSIQ, participants are presented with fourteen ambiguous events related to physical (e.g., feeling lightheaded) or external (e.g., smelling smoke, social situations) concerns, along with three possible explanations for each ambiguous event (one negative, and two neutral or positive explanations). Participants rated the extent to which they believed each explanation for why the ambiguous event occurred on a Likert scale from 0 ("not at all likely") to 4 ("extremely likely"). Typically, the BBSIQ is administered on an eight-point Likert scale, but a 0-4 scale was used to align with other rating scales in the study. Negative interpretation bias score was computed by averaging the likelihood ratings for all negative explanations (following Steinman \& Teachman, 2010, 2015).

Secondary Outcome Measures

Name	Time	Method
Multi-Session User Experience Questionnaire	At 2-month follow-up	This questionnaire assesses users' opinions about the intervention. Participants could select from options "Not at all=0, Slightly=1, Somewhat=2, Mostly=3, Very=4, Decline to answer=5" for questions 1-13 as well as 15 and 16 (examples listed below); question 14 asked "This training program was 8 sessions. How many sessions do you think would have been ideal?" with an open ended response box, which we will not include in the means and SDs. We will recode "Decline to answer=5" as NA. Higher scores on this scale indicate more positive experiences with the program in general across questions, from 0-4. 1. How helpful did you find the web program for reducing your anxiety? 2. How much did the web program improve your overall quality of life? 3. How much did the web program help improve your overall mood (e.g., feeling happier)? 4. How likely would you be to recommend this web program to others with similar anxiety difficulties? 5. How easy was the web program to use?
Impact of Anxious Imagery Prime (Change Over Time is Exploratory But Should Show Anxious/Neutral Prime Differences; e.g., in Subjective Distress)	After sessions 1,2,3,4,5,6,7,8 (sessions will be spaced ~3-4 days apart). Measure will be completed following that day's imagery prime (which immediately precedes the training session).	Following the anxious or neutral imagery prime, participants reported on the questions provided. Minimum score = 3; maximum score =115. Higher scores indicate more vividness and anxiety following the anxious imagery prime. How vividly did you imagine the situation? 1=Not at all vivid 2=Somewhat vivid 3=Moderately vivid 4=Very vivid 5=Totally vivid How anxious did you feel (at the highest level of anxiety) as you completed the imagery task? (using a 0-100 slider with the following anchors marked) 0=Not at all anxious, 50= Moderately anxious, 100=Totally anxious How likely is it that this situation will turn out well vs. turn out badly? 1=Very likely to turn out well, 2=Somewhat likely to turn out well, 3=Neutral, 4= Somewhat likely to turn out badly, 5= Very likely to turn out badly If this situation did turn out badly, how well or badly would you be able to handle it? 1=Very well, 2=Somewhat well, 3=Neutral, 4=Somewhat badly, 5=Very badly
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale	Baseline, after session 8 (~4 weeks after baseline) & at 2-month follow-up.	While we use the OASIS as a primary measure of anxiety symptom severity, we are using the DASS-AS (Lovibond \& Lovibond, 1995) as another 7-item measure of anxiety symptoms. Higher scores indicate more severe anxiety symptoms. Minimum score = 0; maximum score = 21. 0 = Did not apply to me at all 1. = Applied to me to some degree, or some of the time 2. = Applied to me to a considerable degree, or a good part of time 3. = Applied to me very much, or most of the time Qs: 1. I was aware of dryness of my mouth. 2. I experienced breathing difficulty (e.g., excessively rapid breathing, breathlessness in the absence of physical exertion). 3. I experienced trembling (e.g., in the hands). 4. I was worried about situations in which I might panic and make a fool of myself. 5. I felt I was close to panic. 6. I was aware of the action of my heart in the absence of physical exertion (e.g., sense of heart rate increase, heart missing a beat). 7. I felt scared without any good reason.
Change in Quality of Life Scale	Baseline, and after sessions 3 (~2 weeks following baseline), 6 (~10 days after session 3), and 8 (~7 days after session 6) & at 2-month follow-up. Measure will be completed immediately following that day's training session.	The Quality of Life Scale (Flanagan, 1978) is a 16-item questionnaire chosen to evaluate change in quality of life in five domains: recreation, relationships, well-being, personal fulfillment and development, and social activities. Higher scores indicate more positive feelings about quality of life/more satisfaction. Minimum score = 16; maximum score = 80. The question asks "How satisfied are you with..." with each of the following options as separate questions: material, health, relationships, children, spouse, friend, helping, participating, learning, understanding, work, expression, socializing, reading, recreation, independence (just providing a key word for purposes of description, but questions include a full statement such as "Material comforts home, food, conveniences, financial security " for material). Response options range from Completely unsatisfied=1, Somewhat unsatisfied=2, Mixed=3, Somewhat satisfied=4, Completely satisfied=5.