Excessive Worry Clinical Trial
Official title:
The Impact of the Attention Training Technique on Attention Control and High Worry
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 |
Verified date | June 2021 |
Source | Ryerson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Ryerson University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ryerson University | Ministry of Research, Innovation and Science, Ontario |
Canada,
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.
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). |
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