NCT02579915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 7, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

October 16, 2015

Results QC Date

August 23, 2019

Last Update Submit

February 3, 2020

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 7-item Generalized Anxiety Disorder Scale

    6-8 weeks after first treatment session

  • Patient Health Questionnaire-9

    6-8 weeks after first treatment session

Study Arms (2)

FaceAnxiety - Mental Habits

EXPERIMENTAL

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.

Behavioral: FaceAnxietyBehavioral: Symptom Tracking

FaceAnxiety - Symptom Tracking

ACTIVE COMPARATOR

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

Behavioral: Symptom Tracking

Interventions

FaceAnxietyBEHAVIORAL

Computerized treatment targeting mental habits and primary care linkage.

Also known as: Cognitive Bias Modification
FaceAnxiety - Mental Habits
Symptom TrackingBEHAVIORAL

Weekly self-assessment with validated questionnaires and primary care linkage

FaceAnxiety - Mental HabitsFaceAnxiety - Symptom Tracking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Care Center at Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Courtney Beard
Organization
McLean Hospital
CBEARD@MCLEAN.HARVARD.EDU
16178553557

Study Officials

  • Risa B Weisberg, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Courtney Beard, PhD

    Harvard Medical School/McLean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

September 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 7, 2020

Results First Posted

February 7, 2020

Record last verified: 2020-02

Locations

US(1)