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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
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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