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Attention Training for Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMP
Applied Relaxation (AR)
Clinical Monitoring (CM)
Combining the AMP and AR
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, Information Processing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary diagnosis of Generalized Anxiety Disorder

Exclusion Criteria:

  • Evidence of suicidal intent
  • Evidence of current substance abuse
  • Evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
  • Current CBT
  • Change in other psychosocial or pharmacological treatment during the 12 weeks prior to study entry.

Sites / Locations

  • San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

1 Attention Modification Program (AMP)

Applied Relaxation (AR)

Clinical monitoring control

Combining the AMP and AR

Arm Description

The AMP is a computer-delivered attention modification

Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007)

participants assigned to the clinical monitoring (CM) condition will receive the same information about the nature of GAD provided to participants in the active conditions ; however, they will not be randomized to treatment until after the 3-month follow-up assessment. To control for the effects of psychoeducation, symptom monitoring, contact by project staff, and maturation effects, participants will be asked to complete pre-, mid- and post-assessments, and will be informed that they will receive treatment.

Both AMP and AR

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale

Secondary Outcome Measures

Worry Domains Questionnaire

Full Information

First Posted
January 15, 2008
Last Updated
December 6, 2016
Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00602563
Brief Title
Attention Training for Generalized Anxiety Disorder
Official Title
Attention Training for Generalized Anxiety Disorder (Attention Training and Relaxation for GAD: Testing the Efficacy of Home-Delivery)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Generalized Anxiety Disorder (GAD) has high prelevance (up to 8.5%; Roy-Byrne & Wagner, 2004) and leads to functional impairment (Wittchen et al., 2002; Ballenger et al., 2001). Researchers have demonstrated a relationship between attention bias to threatening information and GAD. However, this knowledge has not yet been translated into effective treatments. The goal of this project is develop and test a new computerized treatment for Generalized Anxiety Disorder.
Detailed Description
Generalized Anxiety Disorder (GAD) is characterized by excessive, uncontrollable worry (Barlow, et al., 1986) leading to medical over-utilization, poor perceived health, low ratings of quality of life, and impairment at work resulting in a significant economic and public health impact (Wittchen et al., 2002; Ballenger et al., 2001). Lifetime prevalence of GAD is high (5.7%, Kessler, et al, 2005), with even higher estimates in the primary care setting (8.5%, Roy-Byrne & Wager, 2004). Researchers have established a relationship between GAD and attention bias to threatening information (Mogg & Bradley 2005). This knowledge, however, has not been translated into more effective treatments for this disorder. This five-year, two site proposal aims to test a computerized treatment for GAD in a double-blind, placebo-controlled study bridging basic attention bias research and treatment outcome. We present the results from 7 studies demonstrating the efficacy of attention modification programs (AMP) in ameliorating symptoms of anxiety. Specifically, we report results from a pilot study of individuals with Generalized Anxiety Disorder (n=24, Dr Amir's lab), and high worries (n=24, Dr. Schmidt's lab) demonstrating the effectiveness of the procedures described in this proposal. In brief, our intervention was effective in: a) changing biased attention, b) reducing symptoms of GAD, and c) maintaining its effects in up to one year follow-up. This technique for changing attention bias in GAD can provide a cost-effective and easy to administer treatment grounded in basic cognitive science that may help reduce suffering in individuals with anxiety. A larger study would allow us to test the treatment and examine the generalizability of the intervention to patients with GAD along with comorbid conditions. Moreover, we will examine the transportability of the intervention by examining the proposed intervention at two sites. There are currently 10 participants enrolled in the newest phase of pilot data collection (SDSU 6, FSU 4). The goal of the current proposal is to extend these findings to a larger group of individuals with GAD and to examine the generalizability of the results to individuals with comorbid GAD. In the current proposal we will test two hypotheses: Individuals with GAD completing the AMP will show a larger reduction in their attention bias to threat compared to the clinical monitoring group Individuals with GAD completing AMP will show a larger reduction in anxiety symptoms compared to the clinical monitoring group. Individuals with GAD completing AR will show a larger reduction in anxiety symptoms compared to the clinical monitoring group. Specifically, in the current proposal directly responds to the NIMH priorities for evaluating user-friendly interventions and non-traditional delivery methods to increase access to evidence-based interventions. We will evaluate the efficacy of a 12-week computer-delivered home-based treatment program for GAD. Treatment will comprise a combination of two interventions shown to be efficacious in the treatment of GAD. The Attention Modification Program (AMP) is a computerized program designed to facilitate attention disengagement from threatening stimuli (Amir et al., 2009). Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007). Following the recommended guidelines of the NIMH Workgroup on Psychosocial Intervention Development (Hollon et al., 2002), we review evidence suggesting that both treatments are ideal candidates for the efficient, economical, and widespread transportation of evidence-based treatments for GAD. This proposal has the potential for a significant public health impact by evaluating a new method for delivering evidence-based interventions for hard-to-reach populations through the use of innovative technologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder, Information Processing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Attention Modification Program (AMP)
Arm Type
Experimental
Arm Description
The AMP is a computer-delivered attention modification
Arm Title
Applied Relaxation (AR)
Arm Type
Active Comparator
Arm Description
Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007)
Arm Title
Clinical monitoring control
Arm Type
Placebo Comparator
Arm Description
participants assigned to the clinical monitoring (CM) condition will receive the same information about the nature of GAD provided to participants in the active conditions ; however, they will not be randomized to treatment until after the 3-month follow-up assessment. To control for the effects of psychoeducation, symptom monitoring, contact by project staff, and maturation effects, participants will be asked to complete pre-, mid- and post-assessments, and will be informed that they will receive treatment.
Arm Title
Combining the AMP and AR
Arm Type
Experimental
Arm Description
Both AMP and AR
Intervention Type
Behavioral
Intervention Name(s)
AMP
Intervention Description
The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word.
Intervention Type
Behavioral
Intervention Name(s)
Applied Relaxation (AR)
Intervention Description
Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways to reduce the physiological cues associated with anxiety and worry (Öst, 1987; Siev & Chambless, 2007)
Intervention Type
Behavioral
Intervention Name(s)
Clinical Monitoring (CM)
Intervention Description
participants assigned to the clinical monitoring (CM) condition will receive the same information about the nature of GAD provided to participants in the active conditions
Intervention Type
Behavioral
Intervention Name(s)
Combining the AMP and AR
Intervention Description
The AMP is a computer-delivered attention modification protocol designed to enhance attention disengagement from threatening stimuli. The AMP protocol includes twelve 20-min sessions delivered over a 6-week period. During each session, participants will see 240 trials consisting of the various combinations of probe type (E or F), probe position (top or bottom), and word type (Neutral or Threat). 192 trials include one neutral word and one threat word: 2 (probe type) X 2 (probe position) X 2 (repetitions) X 24 (word pairs). On trials where participants see one neutral word and one threat word (i.e., 80% of the trials), the probe always follows the neutral word. Applied Relaxation (AR) is a behavioral, skills-based intervention where individuals learn ways
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale
Time Frame
Pre, Post, Followup
Secondary Outcome Measure Information:
Title
Worry Domains Questionnaire
Time Frame
Pre, Post, Followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of Generalized Anxiety Disorder Exclusion Criteria: Evidence of suicidal intent Evidence of current substance abuse Evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder Current CBT Change in other psychosocial or pharmacological treatment during the 12 weeks prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Amir, Ph.D.
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31376708
Citation
Amir N, Taboas W, Montero M. Feasibility and dissemination of a computerized home-based treatment for Generalized Anxiety Disorder: A randomized clinical trial. Behav Res Ther. 2019 Sep;120:103446. doi: 10.1016/j.brat.2019.103446. Epub 2019 Jul 26.
Results Reference
derived

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Attention Training for Generalized Anxiety Disorder

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