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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03216382
Other study ID # 2017-186
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2017
Est. completion date June 26, 2019

Study information

Verified date June 2021
Source Ryerson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date June 26, 2019
Est. primary completion date June 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Score of 65 or higher on the Penn State Worry Questionnaire. 2. Endorsement of chronic worry as per the description of Generalized Anxiety Disorder (GAD) (American Psychiatric Association, 2013). Exclusion Criteria: 1. 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 2. Report clinically significant suicidal ideation, intent, or plan 3. 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 4. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attention Training Technique
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.
Control Condition
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.

Locations

Country Name City State
Canada Ryerson University Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ryerson University Ministry of Research, Innovation and Science, Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Review. — View Citation

Wells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990.

Outcome

Type Measure Description Time frame Safety issue
Other UPPS-P Self-report measure of impulsivity. Scores range from 12 to 48. Greater scores indicate greater negative urgency. 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).
Primary Breathing Focus Task -Negative Intrusions 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. 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).
Primary Daily Worry Questions 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. 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.
Secondary Penn State Worry Questionnaire-Past Week 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. 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).
Secondary Self-Attention Rating Scale 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. 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.
Secondary Attention Network Task (ANT) Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control. 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).
Secondary Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale Self-report measure of focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention. 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).
Secondary Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale 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. 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).
Secondary Attention Control Scale Self-report measure of attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control. 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).
Secondary Dot Probe 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. 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).
Secondary Southampton Mindfulness Questionnaire Self-report measure of mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness. 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).
See also
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