Back to results

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

Primary Purpose

Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FaceAnxiety

Symptom Tracking

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Family Care Center at Memorial Hospital of Rhode Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FaceAnxiety - Mental Habits

FaceAnxiety - Symptom Tracking

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

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale

Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.

Secondary Outcome Measures

7-item Generalized Anxiety Disorder Scale

Patient Health Questionnaire-9

Full Information

NCT ID

NCT02579915

First Posted

October 16, 2015

Last Updated

February 3, 2020

Sponsor

Brown University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02579915

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brown University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FaceAnxiety - Mental Habits

Arm Type

Experimental

Arm Description

Arm Title

FaceAnxiety - Symptom Tracking

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

FaceAnxiety

Other Intervention Name(s)

Cognitive Bias Modification

Intervention Description

Computerized treatment targeting mental habits and primary care linkage.

Intervention Type

Behavioral

Intervention Name(s)

Symptom Tracking

Intervention Description

Weekly self-assessment with validated questionnaires and primary care linkage

Primary Outcome Measure Information:

Title

Hamilton Anxiety Rating Scale

Description

Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.

Time Frame

6-8 weeks after first treatment session

Secondary Outcome Measure Information:

Title

7-item Generalized Anxiety Disorder Scale

Time Frame

6-8 weeks after first treatment session

Title

Patient Health Questionnaire-9

Time Frame

6-8 weeks after first treatment session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Risa B Weisberg, PhD

Organizational Affiliation

Brown University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Courtney Beard, PhD

Organizational Affiliation

Harvard Medical School/McLean Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Family Care Center at Memorial Hospital of Rhode Island

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs