Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders (AIM-PC)

Study Overview
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Brief Summary
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The purpose of the study is to develop a personalized, user-friendly computerized treatment for anxiety disorders linked to primary care. The computerized treatment is a type of Cognitive Bias Modification, which targets attention and interpretation biases known to maintain anxiety disorders.

Detailed Description
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The primary goals of our 3-year, 2-phase project are to develop AIM for primary care linkage and assess its feasibility and acceptability. This protocol description only pertains to Phase 2 (Randomized Controlled Trial). 42 primary care patients with primary Generalized Anxiety Disorder, Social Anxiety Disorder, and/or Panic Disorder (with or without Agoraphobia) will be randomly assigned to the AIM treatment or to a symptom tracking control group. Full assessments will occur pre- and post-treatment and 3-months follow-up. A mid-treatment assessment will include measures of cognitive biases and the primary outcome. Weekly measures of anxiety and depression will be collected, as will feedback from patients and PCPs about the research and delivery procedures.

Official Title
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Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: FaceAnxiety
* Behavioral: Symptom Tracking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study site patient Age ≥18 Primary diagnosis of Generalized anxiety disorder (GAD), Social Phobia (SP), and/or panic disorder with or without agoraphobia (PD/A) At least moderate anxiety severity (GAD-7 score > 10) English-speaking If on psychopharmacotherapy, stable dose for 3 months; to minimize learning effects, patients taking benzodiazepines will complete AIM prior to their first dose of the day No current psychotherapy No current severe psychiatric symptoms requiring immediate attention (e.g., imminent suicidality, psychosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FaceAnxiety - Mental Habits<br>Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion. | Behavioral: FaceAnxiety<br>* Computerized treatment targeting mental habits and primary care linkage.<br>* Other names: Cognitive Bias Modification;Behavioral: Symptom Tracking<br>* Weekly self-assessment with validated questionnaires and primary care linkage<br>|
| Active Comparator: FaceAnxiety - Symptom Tracking<br>Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion. | Behavioral: Symptom Tracking<br>* Weekly self-assessment with validated questionnaires and primary care linkage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Scale | Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score. | 6-8 weeks after first treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-item Generalized Anxiety Disorder Scale |  | 6-8 weeks after first treatment session | 
| Patient Health Questionnaire-9 |  | 6-8 weeks after first treatment session |