The Impact of the Attention Training Technique on Attention Control and High Worry
Sponsor
Ryerson University (Other)
Overall Status
Completed
CT.gov ID
NCT03216382
Collaborator
Ministry of Research, Innovation and Science, Ontario (Other)
95
1
2
22.3
4.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Baseline outcome measures will be completed at the first visit to the lab. Participants will then engage in a week of reporting on their worry and attention on their own, before coming back to the lab to recomplete the outcome measures. They will then be randomly assigned to the intervention or control condition and will engage in a week of daily listening to the corresponding recording for their condition on their own, while reporting on their worry and attention again during that week. Outcome measures will be completed again at the lab immediately following the intervention.Baseline outcome measures will be completed at the first visit to the lab. Participants will then engage in a week of reporting on their worry and attention on their own, before coming back to the lab to recomplete the outcome measures. They will then be randomly assigned to the intervention or control condition and will engage in a week of daily listening to the corresponding recording for their condition on their own, while reporting on their worry and attention again during that week. Outcome measures will be completed again at the lab immediately following the intervention.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Impact of the Attention Training Technique on Attention Control and High Worry
Actual Study Start Date
:
Aug 15, 2017
Actual Primary Completion Date
:
Jun 26, 2019
Actual Study Completion Date
:
Jun 26, 2019
Arms and Interventions
| 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. |
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.
|
| 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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Breathing Focus Task -Negative 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).]
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.
- Daily Worry Questions [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.]
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.
Secondary Outcome Measures
- Penn State Worry Questionnaire-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).]
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.
- Self-Attention Rating Scale [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.]
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.
- Attention Network Task (ANT) [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).]
Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control.
- Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale [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 focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention.
- Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale [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 beliefs about the uncontrollability and dangerousness of worry. Scores range from 6-24. Greater scores represent greater negative beliefs about worry.
- Attention Control Scale [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 attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control.
- Dot Probe [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).]
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.
- Southampton Mindfulness Questionnaire [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 mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness.
Other Outcome Measures
- UPPS-P [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ryerson University | Toronto | Ontario | Canada | M5B 2K3 |
Sponsors and Collaborators
- Ryerson University
- Ministry of Research, Innovation and Science, Ontario
Investigators
- Principal Investigator: Kathleen E Stewart, Bsc, Ryerson University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- 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.
- Wells A. Panic disorder in association with relaxation induced anxiety: An attentional training approach to treatment. Behavior Therapy, 21(3): 273-280, 1990.
Responsible Party:
Kathleen Stewart,
Graduate Student,
Ryerson University
ClinicalTrials.gov Identifier:
NCT03216382
Other Study ID Numbers:
- 2017-186
First Posted:
Jul 13, 2017
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kathleen Stewart,
Graduate Student,
Ryerson University
Study Results
Participant Flow
| Recruitment Details | Participants were recruited with flyers and online advertisements. Recruitment took place between 2017-2019 at Ryerson University, Toronto, Ontario, Canada. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Period Title: Overall Study | ||
| STARTED | 41 | 54 |
| COMPLETED | 34 | 44 |
| NOT COMPLETED | 7 | 10 |
Baseline Characteristics
| Arm/Group Title | Attention Training Technique | Control Condition | Total |
|---|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. | Total of all reporting groups |
| Overall Participants | 34 | 44 | 78 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
34
100%
|
44
100%
|
78
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
30.15
(12.35)
|
23.89
(11.25)
|
29.44
(11.68)
|
| Sex/Gender, Customized (Count of Participants) | |||
| Female |
26
76.5%
|
38
86.4%
|
64
82.1%
|
| Male |
8
23.5%
|
5
11.4%
|
13
16.7%
|
| Other |
0
0%
|
1
2.3%
|
1
1.3%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
12
35.3%
|
11
25%
|
23
29.5%
|
| Southeast Asian |
5
14.7%
|
13
29.5%
|
18
23.1%
|
| South Asian |
5
14.7%
|
7
15.9%
|
12
15.4%
|
| East Asian |
3
8.8%
|
8
18.2%
|
11
14.1%
|
| Latin American |
3
8.8%
|
0
0%
|
3
3.8%
|
| Mixed |
3
8.8%
|
2
4.5%
|
5
6.4%
|
| Black |
2
5.9%
|
1
2.3%
|
3
3.8%
|
| Arab/West Asian |
1
2.9%
|
0
0%
|
1
1.3%
|
| Other |
0
0%
|
1
2.3%
|
1
1.3%
|
| Aboriginal |
0
0%
|
1
2.3%
|
1
1.3%
|
| Penn State Worry Questionnaire (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
70.18
(4.08)
|
70.79
(3.69)
|
70.53
(3.85)
|
| Generalized Anxiety Disorder Questionnaire-IV (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
10.39
(1.89)
|
10.04
(2.20)
|
10.19
(2.06)
|
| Center for Epidemiologic Studies Depression Scale-Revised (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
27.53
(13.25)
|
28.25
(12.96)
|
27.94
(13.01)
|
Outcome Measures
| Title | Breathing Focus Task -Negative Intrusions |
|---|---|
| Description | 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. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were only included on this analyses if they had data for all time points. 3 participants were not included (1 from ATT, 2 from control). |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 33 | 42 |
| Visit 1 |
2.85
(2.32)
|
2.55
(1.99)
|
| Visit 2 |
2.45
(2.53)
|
2.26
(1.93)
|
| Visit 3 |
1.79
(2.13)
|
1.64
(1.82)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .93 |
| Comments | The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Daily Worry Questions |
|---|---|
| Description | 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. |
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 44 |
| Day 1 |
3.66
(1.14)
|
3.15
(1.52)
|
| Day 2 |
3.56
(1.83)
|
3.63
(1.70)
|
| Day 3 |
2.86
(1.78)
|
3.34
(1.83)
|
| Day 4 |
3.48
(1.75)
|
3.28
(1.80)
|
| Day 5 |
3.34
(1.50)
|
3.41
(1.62)
|
| Day 6 |
3.11
(1.50)
|
3.17
(1.54)
|
| Day 7 |
3.56
(1.48)
|
3.18
(1.66)
|
| Day 8 |
3.55
(1.60)
|
3.56
(1.52)
|
| Day 9 |
2.87
(1.52)
|
3.43
(1.69)
|
| Day 10 |
3.13
(1.79)
|
3.63
(1.54)
|
| Day 11 |
3.28
(1.45)
|
3.13
(1.53)
|
| Day 12 |
3.15
(1.78)
|
3.44
(1.98)
|
| Day 13 |
3.31
(1.61)
|
3.11
(1.67)
|
| Day 14 |
2.97
(1.54)
|
3.03
(1.67)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .74 |
| Comments | this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .44 |
| Comments | this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Penn State Worry Questionnaire-Past Week |
|---|---|
| Description | 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. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were only included on this analyses if they had data for all time points. 1 participant was not included from the control condition. |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 43 |
| Visit 1 |
71.91
(9.23)
|
72.72
(8.69)
|
| Visit 2 |
67.38
(13.15)
|
67.51
(12.13)
|
| Visit 3 |
61.06
(13.51)
|
63.07
(15.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .17 |
| Comments | the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Self-Attention Rating Scale |
|---|---|
| Description | 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. |
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 33 | 44 |
| Day 1 |
3.72
(1.41)
|
3.56
(1.37)
|
| Day 2 |
3.11
(1.67)
|
3.11
(1.56)
|
| Day 3 |
3.18
(1.49)
|
3.69
(1.51)
|
| Day 4 |
3.17
(1.50)
|
3.00
(1.58)
|
| Day 5 |
3.61
(1.40)
|
3.00
(1.76)
|
| Day 6 |
3.75
(1.62)
|
3.64
(1.66)
|
| Day 7 |
4.11
(1.50)
|
3.33
(1.69)
|
| Day 8 |
3.03
(1.30)
|
3.44
(1.50)
|
| Day 9 |
2.87
(1.71)
|
3.30
(1.33)
|
| Day 10 |
3.48
(1.88)
|
3.25
(1.55)
|
| Day 11 |
3.06
(1.59)
|
3.29
(1.45)
|
| Day 12 |
3.08
(1.79)
|
3.27
(1.50)
|
| Day 13 |
3.41
(1.59)
|
3.18
(1.41)
|
| Day 14 |
3.69
(1.42)
|
3.05
(1.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .50 |
| Comments | The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time . | |
| Method | Mixed Models Analysis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .02 |
| Comments | The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared). | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Attention Network Task (ANT) |
|---|---|
| Description | Behavioural measure of general attentional control, using reaction time. A larger number suggests lower attention control, whereas a smaller number suggests greater attention control. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were only included on this analyses if they had data for all time points. 10 participants were not included (2 from ATT, 8 from control). |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 32 | 36 |
| Visit 1 |
104.60
(40.74)
|
108.82
(40.59)
|
| Visit 2 |
80.02
(33.43)
|
85.58
(31.85)
|
| Visit 3 |
80.51
(44.14)
|
76.76
(42.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .46 |
| Comments | the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Metacognition Questionnaire 30 (MCQ-30) Cognitive Self Consciousness Subscale |
|---|---|
| Description | Self-report measure of focus of attention. Scores range from 6- 24. Greater scores represent greater self-focused attention. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 44 |
| Visit 1 |
17.21
(3.41)
|
17.84
(3.88)
|
| Visit 2 |
17.56
(3.27)
|
18.02
(4.07)
|
| Visit 3 |
16.65
(3.56)
|
17.82
(4.31)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .53 |
| Comments | the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Metacognitions Questionnaire 30 (MCQ-30) Negative Beliefs About the Uncontrollability of Thoughts and Danger Subscale |
|---|---|
| Description | 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. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 44 |
| Visit 1 |
17.68
(3.65)
|
18.07
(3.59)
|
| Visit 2 |
17.00
(3.68)
|
17.84
(3.77)
|
| Visit 3 |
15.21
(4.30)
|
17.36
(3.62)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .07 |
| Comments | the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Attention Control Scale |
|---|---|
| Description | Self-report measure of attentional control. Scores range from 20-80. Greater scores indicate greater self-reported attention control. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were only included on this analyses if they had data for all time points. 1 participant was not included from the control condition. |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 43 |
| Visit 1 |
47.59
(9.78)
|
44.09
(7.68)
|
| Visit 2 |
46.62
(8.21)
|
44.61
(7.28)
|
| Visit 3 |
49.17
(10.62)
|
46.72
(8.31)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .58 |
| Comments | the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Dot Probe |
|---|---|
| Description | 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. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants were only included on this analyses if they had data for all time points. 17 participants were not included (10 from ATT, 7 from control). A substantial amount of data was lost due to a technical issue with the computer. |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 24 | 37 |
| Visit 1 |
6.78
(19.12)
|
-1.75
(19.54)
|
| Visit 2 |
2.14
(15.85)
|
-2.42
(19.66)
|
| Visit 3 |
0.65
(17.81)
|
-5.83
(23.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .86 |
| Comments | the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | Southampton Mindfulness Questionnaire |
|---|---|
| Description | Self-report measure of mindfulness. Scores range from 0-96. Greater scores indicate greater self-reported mindfulness. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 44 |
| Visit 1 |
36.09
(12.93)
|
32.21
(11.93)
|
| Visit 2 |
36.38
(13.41)
|
34.77
(12.21)
|
| Visit 3 |
43.88
(12.47)
|
38.68
(13.35)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Attention Training Technique, Control Condition |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .39 |
| Comments | the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time. | |
| Method | ANOVA | |
| Comments | ||
| Title | UPPS-P |
|---|---|
| Description | Self-report measure of impulsivity. Scores range from 12 to 48. Greater scores indicate greater negative urgency. |
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Attention Training Technique | Control Condition |
|---|---|---|
| Arm/Group Description | 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. 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. | 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. 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. |
| Measure Participants | 34 | 44 |
| Visit 1 |
29.85
(6.42)
|
31.98
(7.12)
|
| Visit 2 |
28.71
(7.15)
|
31.43
(7.28)
|
| Visit 3 |
28.32
(6.59)
|
29.39
(8.28)
|
Adverse Events
| Time Frame | 2 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Attention Training Technique | Control Condition | ||
| Arm/Group Description | 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. 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. | 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. 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. | ||
All Cause Mortality |
||||
| Attention Training Technique | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/44 (0%) | ||
Serious Adverse Events |
||||
| Attention Training Technique | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/44 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Attention Training Technique | Control Condition | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/34 (0%) | 0/44 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Naomi Koerner |
|---|---|
| Organization | Ryerson University |
| Phone | 416-979-5000 ext ext. 5521 |
| naomi.koerner@ryerson.ca |
Responsible Party:
Kathleen Stewart,
Graduate Student,
Ryerson University
ClinicalTrials.gov Identifier:
NCT03216382
Other Study ID Numbers:
- 2017-186
First Posted:
Jul 13, 2017
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021