Attention Training for Generalized Anxiety Disorder - Full Text View

Sponsored by:	San Diego State University
Information provided by:	San Diego State University
ClinicalTrials.gov Identifier:	NCT00602563

Purpose

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.

Condition	Intervention
Generalized Anxiety Disorder	Behavioral: AMP Behavioral: PC

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	Attention Training for Generalized Anxiety Disorder

Further study details as provided by San Diego State University:

Primary Outcome Measures:

Hamilton Anxiety Rating Scale [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Worry Domains Questionnaire [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Attention Modification Program	Behavioral: AMP The AMP protocol includes eight 30-min sessions delivered over a 4-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). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 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.
2: Placebo Comparator Placebo Condition	Behavioral: PC The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat word is present, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value with regard to the position of the probe.

Arms

Assigned Interventions

1: Experimental

Attention Modification Program

Behavioral: AMP

The AMP protocol includes eight 30-min sessions delivered over a 4-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). Of the 240 trials, 48 include only neutral words: 2 (probe type) X 2 (probe position) X 12 (word pairs). The remaining 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.

2: Placebo Comparator

Placebo Condition

Behavioral: PC

The placebo condition (PC) will be identical to the AMP condition except that during the presentation of the trials where a threat word is present, the probe will appear with equal frequency in the position of threat and neutral words. Thus, neither threat nor neutral words have signal value with regard to the position of the probe.

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 placebo group
Individuals with GAD completing AMP will show a larger reduction in anxiety symptoms compared to the placebo group.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602563

Contacts

Contact: Nader Amir, Ph.D.

619-229-3740

namir@mail.sdsu.edu

Locations

United States, California
San Diego State University	Recruiting
San Diego, California, United States, 92120

Sponsors and Collaborators

San Diego State University

Investigators

Principal Investigator:

Nader Amir, Ph.D.

San Diego State University

More Information

Responsible Party:	San Diego State University ( Nader Amir, Ph.D. )
Study ID Numbers:	1R01MH081938-01A1, 1R01MH081938-01A1
Study First Received:	January 15, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00602563
Health Authority:	United States: Institutional Review Board

Keywords provided by San Diego State University:

Generalized Anxiety Disorder
Information Processing

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 14, 2009