Attention Training for Generalized Anxiety Disorder

NCT00602563 | Completed DMC

• 2 other identifiers: 5R01MH087623-04R01MH087623
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Information Processing

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale

  Pre, Post, Followup

Secondary Outcomes (1)

• Worry Domains Questionnaire

  Pre, Post, Followup

Study Arms (4)

1 Attention Modification Program (AMP)

EXPERIMENTAL

The AMP is a computer-delivered attention modification

Behavioral: AMP

Applied Relaxation (AR)

ACTIVE COMPARATOR

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)

Clinical monitoring control

PLACEBO COMPARATOR

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)

Combining the AMP and AR

EXPERIMENTAL

Both AMP and AR

Behavioral: Combining the AMP and AR

Interventions

AMP BEHAVIORAL

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.

1 Attention Modification Program (AMP)

Applied Relaxation (AR) BEHAVIORAL

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)

Applied Relaxation (AR)

Clinical Monitoring (CM) BEHAVIORAL

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

Clinical monitoring control

Combining the AMP and AR BEHAVIORAL

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

Combining the AMP and AR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of Generalized Anxiety Disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

Location

Related Publications (1)

• 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.

  PMID: 31376708 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Adenosine Monophosphate; Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Nader Amir, Ph.D.

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

US (1)