NCT03216382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

July 11, 2017

Results QC Date

May 17, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

High worryAnxietyAttention Training TechniqueAttention ControlAttentionMindfulnessAttention BiasWorryPathological WorryAnxiety Disorder

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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 Outcomes (8)

  • 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-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.

  • 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).

  • 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).

  • 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).

  • +3 more secondary outcomes

Other Outcomes (1)

  • 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).

Study Arms (2)

Attention Training Technique

EXPERIMENTAL

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

Control Condition

PLACEBO COMPARATOR

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

Interventions

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.

Attention Training Technique

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.

Control Condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (3)

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

    BACKGROUND
  • 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.

    PMID: 27129094BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Dr. Naomi Koerner
Organization
Ryerson University

Study Officials

  • Kathleen E Stewart, Bsc

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 13, 2017

Study Start

August 15, 2017

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

July 2, 2021

Results First Posted

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

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.

Locations