Attention Training for Generalized Anxiety Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by San Diego State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nader Amir, San Diego State University
ClinicalTrials.gov Identifier:
NCT00602563
First received: January 15, 2008
Last updated: March 30, 2015
Last verified: March 2015
  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: Applied Relaxation (AR)
Behavioral: Clinical Monitoring (CM)
Behavioral: Combining the AMP and AR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Training for Generalized Anxiety Disorder (Attention Training and Relaxation for GAD: Testing the Efficacy of Home-Delivery)

Resource links provided by NLM:


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 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Attention Modification Program (AMP)
The AMP is a computer-delivered attention modification
Behavioral: AMP
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.
Active Comparator: Applied Relaxation (AR)
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)
Behavioral: Applied Relaxation (AR)
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)
Placebo Comparator: Clinical monitoring control
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.
Behavioral: Clinical Monitoring (CM)
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
Experimental: Combining the AMP and AR
Both AMP and AR
Behavioral: Combining the AMP and AR
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

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:

  1. Individuals with GAD completing the AMP will show a larger reduction in their attention bias to threat compared to the clinical monitoring group
  2. Individuals with GAD completing AMP will show a larger reduction in anxiety symptoms compared to the clinical monitoring group.
  3. 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Nader Amir, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT00602563     History of Changes
Other Study ID Numbers: 5R01MH087623-04, 5R01MH087623-04, R01MH087623
Study First Received: January 15, 2008
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Generalized Anxiety Disorder
Information Processing

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 30, 2015