Developing a Low-Intensity Primary Care Intervention for Anxiety Disorders

NCT02266446 | Completed DMC

• 2 other identifiers: 13080009081R34MH097820-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

anxiety disorders; cognitive bias modification; primary care; attention; interpretation; computer

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire

  6-8 weeks after first treatment session

Secondary Outcomes (2)

• Generalized Anxiety Disorder 7-Item Scale

  6-8 weeks after first treatment session

• Patient Health Questionnaire-9

  6-8 weeks after first treatment session

Study Arms (1)

Attention & Interpretation Modification

EXPERIMENTAL

The final product will be web-delivered, so it may be completed at the clinic or home. 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

Behavioral: Attention & Interpretation Modification

Interventions

Attention & Interpretation Modification BEHAVIORAL

Also known as: AIM, Cognitive Bias Modification

Attention & Interpretation Modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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)

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator
• Memorial Hospital of Rhode Island: collaborator
• Mclean Hospital: collaborator

Study Sites (1)

Family Care Center of Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Risa B Weisberg, PhD

  Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

• Courtney Beard, PhD

  Harvard Medical School/McLean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open trial

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: October 17, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)