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

Overview

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.

Full Title of Study: “Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

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.

Interventions

  • Behavioral: FaceAnxiety
    • Computerized treatment targeting mental habits and primary care linkage.
  • Behavioral: Symptom Tracking
    • Weekly self-assessment with validated questionnaires and primary care linkage

Arms, Groups and Cohorts

  • Experimental: FaceAnxiety – Mental Habits
    • 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.
  • Active Comparator: FaceAnxiety – Symptom Tracking
    • Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 7-item Generalized Anxiety Disorder Scale
    • Time Frame: 6-8 weeks after first treatment session
  • Patient Health Questionnaire-9
    • Time Frame: 6-8 weeks after first treatment session

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brown University
  • Collaborator
    • Mclean Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Courtney Beard, Principal Investigator – Brown University
  • Overall Official(s)
    • Risa B Weisberg, PhD, Principal Investigator, Brown University
    • Courtney Beard, PhD, Principal Investigator, Harvard Medical School/McLean Hospital

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