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The Impact of the Attention Training Technique on Attention Control and High Worry

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ClinicalTrials.gov Identifier: NCT03216382
Recruitment Status : Completed
First Posted : July 13, 2017
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Ministry of Research, Innovation and Science, Ontario
Information provided by (Responsible Party):
Kathleen Stewart, Ryerson University

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
Excessive Worry Behavioral: Attention Training Technique Behavioral: Control Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : August 15, 2017
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

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.




Primary Outcome Measures :
  1. Breathing focus task [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Behavioural measure of attention control over worry

  2. 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. ]
    A daily self-report measure of the frequency, duration, intensity and uncontrollability of worry


Secondary Outcome Measures :
  1. Penn State Worry Questionnaire-Past Week [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of the degree of worry experienced over the past week

  2. 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. ]
    A daily self-report measure of focus of attention (from internal to externally focused)

  3. Attention Network Task (ANT) [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Behavioural measure of general attentional control

  4. 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 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of focus of attention

  5. 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 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of beliefs about the uncontrollability and dangerousness of worry

  6. Attention Control Scale [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of attentional control

  7. Dot Probe [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Behavioural measure of attentional bias to threat related words

  8. Southampton Mindfulness Questionnaire [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of mindfulness


Other Outcome Measures:
  1. UPPS-P [ Time Frame: Administered three times over the course of two weeks. Changes will be examined from visit 1 (before monitoring worry) to visit 2 (after monitoring worry and before starting the intervention), and from visit 2 to visit 3 (immediately post intervention). ]
    Self-report measure of impulsivity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216382


Locations
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Canada, Ontario
Ryerson University
Toronto, Ontario, Canada, M5B 2K3
Sponsors and Collaborators
Ryerson University
Ministry of Research, Innovation and Science, Ontario
Investigators
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Principal Investigator: Kathleen E Stewart, Bsc Ryerson University

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

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Responsible Party: Kathleen Stewart, Graduate Student, Ryerson University
ClinicalTrials.gov Identifier: NCT03216382    
Other Study ID Numbers: 2017-186
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Stewart, Ryerson University:
High worry
Anxiety
Attention Training Technique
Attention Control
Attention
Mindfulness
Attention Bias
Worry
Pathological Worry
Anxiety Disorder