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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579915
• Other study ID #: 1308000908-Phase 2
• Secondary ID: 1R34MH097820-01A
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Family Care Center at Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Brown University	Mclean Hospital, Memorial Hospital of Rhode Island, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-item Generalized Anxiety Disorder Scale		6-8 weeks after first treatment session
Secondary	Patient Health Questionnaire-9		6-8 weeks after first treatment session