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

Not Applicable

Completed

Conditions: Anxiety Disorders

Registration Number: NCT02579915

Lead Sponsor: Brown University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale	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 Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	6-8 weeks after first treatment session
7-item Generalized Anxiety Disorder Scale	6-8 weeks after first treatment session

Trial Locations

Locations (1): Family Care Center at Memorial Hospital of Rhode Island
🇺🇸
Pawtucket, Rhode Island, United States
Family Care Center at Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States