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

Brown University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Symptom Tracking; Behavioral: FaceAnxiety

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02579915

1R34MH097820-01A1 (U.S. NIH Grant/Contract)

1308000908-Phase 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

FaceAnxiety - Mental Habits

Experimental group

Description:

Treatment will consist of 8, 30-minute, twice-weekly sessions designed to: a) decrease attention bias to threat and b) extinguish threat interpretations/reinforce benign interpretations of ambiguity. Attention bias will be modified via a dot probe task that increases attentional control by directing attention away from threat faces via probe location. Patients will complete 256 trials per session. Interpretation bias will be modified via a word-sentence association task which provides positive feedback when participants endorse benign interpretations of ambiguous sentences and negative feedback for threat interpretations. Participants will complete 150 training trials per session. A FaceAnxiety Specialist facilitates program completion.

Treatment:

Behavioral: FaceAnxiety

Behavioral: Symptom Tracking

FaceAnxiety - Symptom Tracking

Active Comparator group

Description:

Treatment will consist of weekly self-assessment of anxiety and depression symptoms via on-line surveys. A FaceAnxiety Specialist will facilitate program completion.

Treatment:

Behavioral: Symptom Tracking