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OpenTrials
Completed

NCT Number: NCT02579915

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Care Center at Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FaceAnxiety

Behavioral

Computerized treatment targeting mental habits and primary care linkage.

Other names: Cognitive Bias Modification

Symptom TRacking

Behavioral

Weekly self-assessment with validated questionnaires and primary care linkage

Primary outcomes

  1. 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

  1. 7-item Generalized Anxiety Disorder Scale

    Time frame: 6-8 weeks after first treatment session

  2. Patient Health Questionnaire-9

    Time frame: 6-8 weeks after first treatment session

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • Mclean Hospital
  • Memorial Hospital of Rhode Island
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2015
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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