Generalized Anxiety DisorderNCT00602563
Attention Training for Generalized Anxiety Disorder
A study testing AMP, Applied Relaxation (AR) and Clinical Monitoring (CM) in people with Generalized Anxiety Disorder, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- AMP, Applied Relaxation (AR) and Clinical Monitoring (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Generalized Anxiety Disorder
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92120
About this study
Official title: Attention Training for Generalized Anxiety Disorder (Attention Training and Relaxation for GAD: Testing the Efficacy of Home-Delivery)
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- AMP, Applied Relaxation (AR), Clinical Monitoring (CM), Combining the AMP and AR
- Keywords
- Generalized Anxiety Disorder, Information Processing
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMPBehavioural
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)Behavioural
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)
Clinical Monitoring (CM)Behavioural
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
Combining the AMP and ARBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 1 Attention Modification Program (AMP) | Experimental | The AMP is a computer-delivered attention modification Receives: 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) Receives: 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. Receives: Behavioral: Clinical Monitoring (CM) |
| Combining the AMP and AR | Experimental | Both AMP and AR Receives: Behavioral: Combining the AMP and AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale
Measured: Pre, Post, Followup
Secondary outcomes (1)
Worry Domains Questionnaire
Measured: Pre, Post, Followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nader Amir, San Diego State University
- Investigators
- Nader Amir, Ph.D., Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602563
- Sponsor's protocol ID
- 5R01MH087623-04
- Other IDs
- 5R01MH087623-04, R01MH087623
- Status last verified
- Dec 2016
- First submitted
- 15 Jan 2008
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31376708
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Training for Generalized Anxiety Disorder (Attention Training and Relaxation for GAD: Testing the Efficacy of Home-Delivery)
- ClinicalTrials.gov ID
- NCT00602563
- Acronym / sponsor ID
- 5R01MH087623-04
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Information Processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2007
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Attention Modification Program (AMP) | Experimental | Behavioral: AMPThe AMP is a computer-delivered attention modification |
| Applied Relaxation (AR) | Active comparator | 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) |
| Clinical monitoring control | Placebo comparator | 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 ; 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. |
| Combining the AMP and AR | Experimental | Behavioral: Combining the AMP and ARBoth AMP and AR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of Generalized Anxiety Disorder
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMPThe 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. | Behavioural | 1 Attention Modification Program (AMP) |
| 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) | Behavioural | Applied Relaxation (AR) |
| 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 | Behavioural | Clinical monitoring control |
| Combining the AMP and ARThe 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 | Behavioural | Combining the AMP and AR |
Primary outcome
Hamilton Anxiety Rating Scale
Time frame: Pre, Post, Followup
1 secondary outcome
Worry Domains Questionnaire
Time frame: Pre, Post, Followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Derived from this study: PubMed 31376708Amir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Amir, Ph.D. principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMP, Applied Relaxation (AR) and Clinical Monitoring (CM) in people with Generalized Anxiety Disorder, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (time frame: Pre, Post, Followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00602563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.