- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216382
The Impact of the Attention Training Technique on Attention Control and High Worry
June 10, 2021 updated by: Kathleen Stewart, Ryerson University
Excessive and uncontrollable worry has been associated with deficits in attention control.
The Attention Training Technique (ATT; Wells, 1990) is a 12-minute audio recording that was developed to train attention control, so that individuals could learn to shift their attention away from maladaptive cognitive processes such as worry.
The technique has shown to be promising at reducing symptoms across a variety of mental disorders (Knowles, Foden, El-Deredy, & Wells, 2016) and is recommended for use in people who suffer from chronic worry.
To date, little research has been conducted examining the benefits of using this technique in such a population.
The present study aims to examine the immediate and short term effects of weekly ATT practice, compared to a control condition, in a population that suffers from high levels of worry about a variety of topics.
About one-hundred participants who suffer from chronic worry will be randomly assigned to listen to the ATT or a control recording, every day for a week.
Changes in attention control, worry, and cognitive processes will be examined over the course of the intervention period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
People who suffer from pathological worry report that they worry to an excessive degree and that they find it very difficult to control their worry.
Deficits in attention control may help to explain why people who worry pathologically find it difficult to shift their attention away from their worry, and back to the task at hand.
The Attention Training Technique (ATT; Wells, 1990) was developed to train attentional control, so that individuals could learn to shift the focus of their attention away from maladaptive cognitive processes such as worry.
Despite being recommended for use in populations that suffer from excessive worry, there is a dearth of research examining the effects of ATT in such a population.
The study aims to examine the immediate (during the intervention) and short-term (right after finishing the intervention) effects of listening to the ATT, compared to the control recording, on attention, worry, and other cognitive processes.
This will be the first study to our knowledge to examine the effects of 1 week of daily ATT practice in a sample of people who suffer from chronic worry, and will provide important information for optimizing the treatment of worry in this population.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- Ryerson University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Score of 65 or higher on the Penn State Worry Questionnaire.
- Endorsement of chronic worry as per the description of Generalized Anxiety Disorder (GAD) (American Psychiatric Association, 2013).
Exclusion Criteria:
- Has current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
- Report clinically significant suicidal ideation, intent, or plan
- Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), unless this treatment is infrequent (once monthly or less) or the participant has been receiving consistent weekly treatment for at least 12 weeks and still meets all other eligibility criteria
- Are taking psychotropic medications and have had a change in dose in the past 12 weeks. If they have recently discontinued a psychotropic medication, they will be included if it has been at least 1 month since discontinuation, or 3 months if they had been taking fluoxetine/Prozac. If a participant is taking benzodiazepines on an 'as needed' basis they will be included and their use of this medication will be noted. Daily benzodiazepine usage will exclude participants, and if participants have ever taken benzodiazepines daily, they must be abstinent for at least one year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Attention Training Technique
Participants in this arm will listen to the Attention Training Technique.
Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week.
For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.
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The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds.
The sounds play continuously during the training task.
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Placebo Comparator: Control Condition
Participants in this arm will listen to the control condition recording.
Participants will listen to the recording once in the lab, followed by a week of once/day listening at home for a week.
For a week before the intervention, and for the week during the intervention, participants will respond to questions every evening, about their worry and attention that day.
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In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breathing Focus Task -Negative Intrusions
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Behavioural measure of attention control over worry.
Number of negative thought intrusions reported during the post-worry breathing focus period (i.e. a period of focused breathing after a period of worry).
Scores range from 0-12.
A greater number means more negative thought intrusions.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Daily Worry Questions
Time Frame: Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
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A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry.
Only uncontrollability of worry was used (see Data Analysis Plan for rationale).
Scores range from 0-6.
Higher scores represent greater uncontrollability of worry.
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Completed every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Penn State Worry Questionnaire-Past Week
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-report measure of the degree of worry experienced over the past week.
Scores range from 15 to 75.
Higher scores indicate higher worry over the past week.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-Attention Rating Scale
Time Frame: Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
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A daily self-report measure of focus of attention (from internal to externally focused).
The scale ranges from 0 to 6. 0 represents entirely externally focused and 6 represents entirely internally focused.
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Completed before and after listening to the recoding (immediate change) and every evening for two weeks. The first week will take place before beginning the ATT/ control intervention. The second week will take place during the intervention period.
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Attention Network Task (ANT)
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Behavioural measure of general attentional control, using reaction time.
A larger number suggests lower attention control, whereas a smaller number suggests greater attention control.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-report measure of focus of attention.
Scores range from 6- 24.
Greater scores represent greater self-focused attention.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-report measure of beliefs about the uncontrollability and dangerousness of worry.
Scores range from 6-24.
Greater scores represent greater negative beliefs about worry.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Attention Control Scale
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-report measure of attentional control.
Scores range from 20-80.
Greater scores indicate greater self-reported attention control.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Dot Probe
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Behavioural measure of attentional bias to threat related words, measured in reaction time.
A larger positive number indicates a greater bias to threat information while a negative number indicates the participant was faster to respond to neutral information.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Southampton Mindfulness Questionnaire
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Self-report measure of mindfulness.
Scores range from 0-96.
Greater scores indicate greater self-reported mindfulness.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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UPPS-P
Time Frame: Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
|
Self-report measure of impulsivity.
Scores range from 12 to 48.
Greater scores indicate greater negative urgency.
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Administered three times over the course of two weeks. Changes will be examined from Visit 1 (Baseline) to Visit 2 (Preintervention, 1 week following Baseline) and Visit 2 to Visit 3 (1 week following preintervention).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathleen E Stewart, Bsc, Ryerson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990.
- Knowles MM, Foden P, El-Deredy W, Wells A. A Systematic Review of Efficacy of the Attention Training Technique in Clinical and Nonclinical Samples. J Clin Psychol. 2016 Oct;72(10):999-1025. doi: 10.1002/jclp.22312. Epub 2016 Apr 29.
- Stewart KE, Antony MM, Koerner N. A randomized experimental analysis of the attention training technique: Effects on worry and relevant processes in individuals with probable generalized anxiety disorder. Behav Res Ther. 2021 Jun;141:103863. doi: 10.1016/j.brat.2021.103863. Epub 2021 Apr 10.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2017
Primary Completion (Actual)
June 26, 2019
Study Completion (Actual)
June 26, 2019
Study Registration Dates
First Submitted
July 11, 2017
First Submitted That Met QC Criteria
July 11, 2017
First Posted (Actual)
July 13, 2017
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
June 10, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Results of the study will be disseminated via conference presentations, journal publications, and through our lab website.
Upon request, de-identified aggregate participant data may be made available to a publishing journal or individual research group.
Individual research groups interested in accessing de-identified data will be required to submit a proposal detailing their intended use of the data.
Their qualifications will be reviewed based on their proposal and CVs.
Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal.
No individual data will be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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