Phase 2 Randomized Controlled Trial of Attention and Interpretation Modification (AIM) for Anxiety Disorders in Primary Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anxiety Disorders
- Sponsor
- Brown University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Hamilton Anxiety Rating Scale
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Courtney Beard
Principal Investigator
Brown University
Eligibility Criteria
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)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Patient Health Questionnaire-9(6-8 weeks after first treatment session)
- 7-item Generalized Anxiety Disorder Scale(6-8 weeks after first treatment session)