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Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Worry Postponement
Worry Monitoring
Sponsored by
Toronto Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Worry Postponement, Stimulus Control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Endorse symptoms consistent with a primary diagnosis of Generalized Anxiety Disorder (GAD) as defined by DSM-5 (APA, 2013), with a clinician severity rating (CSR) ≥ 4
  2. If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis.

Exclusion Criteria:

  1. Have a 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 (meeting once monthly or less) or the participant has been receiving consistent weekly treatment for 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 psychotropic medication on an as needed basis (e.g., benzodiazepines), they will be included and their use of this medication will be noted in order to assess whether it has a moderating effect on intervention outcome.

Sites / Locations

  • Ryerson University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Worry Postponement

Worry Monitoring

Assessment Only Control

Arm Description

Two weeks of daily worry postponement

Two weeks of daily worry monitoring

No intervention, participants will complete three assessment time points

Outcomes

Primary Outcome Measures

Change in worry as measures by the Penn State Worry Questionnaire - Past Week

Secondary Outcome Measures

Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised
Change in mindfulness as measured by the Southampton Mindfulness Questionnaire
Change in problem solving as measured by Social Problem Solving Inventory - Revised
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Change in attentional control as measured by the Random Interval Generation Task
Change in attentional control as measured by the N-back task
Change in worry frequency as measured by daily worry diaries
Change in meta cognitive beliefs about worry as measured by the Metacognitions Questionnaire-30
Change in attentional control over worry as measured by the Breathing Focus Task
Change in symptoms of depression as measured by the Depression, Anxiety, and Stress Scales - 21
Change in symptoms of anxiety as measured by the Depression, Anxiety, and Stress Scales - 21
Change in symptoms of insomnia as measured by the Insomnia Severity Index
Change in health complaints as measured by the Subjective Health Complaints Questionnaire
Change in rumination as measured by the Ruminative Response Scales

Full Information

First Posted
June 13, 2016
Last Updated
July 17, 2018
Sponsor
Toronto Metropolitan University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02806271
Brief Title
Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
Official Title
Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Despite being commonly recommended, there is little known about the efficacy and mechanisms of worry postponement. The purpose of this study is to determine the efficacy and mechanisms of change of a two-week worry postponement intervention in people with Generalized Anxiety Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only control condition. Changes in worry or associated features will be examined at post intervention and at a 2-week follow up.
Detailed Description
Generalized Anxiety Disorder (GAD) is a disorder characterized by excessive and uncontrollable worry. People with GAD report that worry significantly interferes with their ability to enjoy their life and function effectively in their roles. Worry postponement is a treatment technique developed by Borkovec and colleagues (1983) to reduce excessive worry. In worry postponement, people are instructed to notice naturally occurring episodes of worry and to then disengage from their worry and postpone it to a designated 30 minute "worry period" later in the day. People are instructed to confine their worry to this 30 minute period and to use that period to problem solve concerns they have been having. Worry postponement is a widely recommended technique for treating excessive worry in people with GAD and is often combined with other cognitive-behavioural interventions. Despite being commonly recommended, there are very few studies demonstrating worry postponement's efficacy for reducing worry, and no studies have looked at the effect of this intervention in people with GAD. The present study aims to extend the literature by comparing a two-week worry postponement intervention to worry monitoring alone and to an assessment only control condition. Participants will complete baseline self-report measures of worry and associated symptoms and cognitive processes. They will complete three computer tasks measuring attention control. They will then be randomized to one of three conditions (worry postponement, worry monitoring, assessment only control). Participants will follow instructions corresponding to their condition daily for two weeks. In the worry postponement and worry monitoring conditions this will involve completing brief daily worry questionnaires at home for the two weeks of the intervention. In the assessment only condition participants will not complete any measures during the two weeks after the first session. Subsequent to this, all participants will return to the lab to repeat baseline measures, and will return again two weeks later to complete measures. The entire study will require three lab visits, spanning over four weeks. This study aims to determine what the effects of worry postponement are, relative to worry monitoring and assessment only, on worry, GAD and associated symptoms, and cognitive processes related to worry. A secondary aim of this study is to examine which mechanisms predict change in worry in a worry postponement study. This will be the first study to our knowledge, to examine these questions in a sample of people with GAD. This study will provide important information for optimizing the treatment of worry in people with GAD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Worry Postponement, Stimulus Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Worry Postponement
Arm Type
Experimental
Arm Description
Two weeks of daily worry postponement
Arm Title
Worry Monitoring
Arm Type
Active Comparator
Arm Description
Two weeks of daily worry monitoring
Arm Title
Assessment Only Control
Arm Type
No Intervention
Arm Description
No intervention, participants will complete three assessment time points
Intervention Type
Behavioral
Intervention Name(s)
Worry Postponement
Other Intervention Name(s)
Stimulus Control for Worry
Intervention Description
In worry postponement, participants are instructed to learn to notice naturally occurring episodes of worry. When they notice they are worrying they are instructed to disengage from their worry and postpone it to a designated 30 minute "worry period" to be carried out at the same time and place daily during the two week intervention. Participants are to use their worry time to worry about problems that have come up during the day and to problem solve where appropriate.
Intervention Type
Behavioral
Intervention Name(s)
Worry Monitoring
Intervention Description
For two weeks participants are instructed to monitor their worry using a smartphone based application. Participants are instructed to make a record each time they have a worry episode by briefly describing the content of their worry. Participants also complete two brief daily questionnaires about the duration of their worry, the intensity of their worry, their ability to disengage from their worry, and the occurrence of nighttime episodes of worry.
Primary Outcome Measure Information:
Title
Change in worry as measures by the Penn State Worry Questionnaire - Past Week
Time Frame
This measure will be administered four times over the course of the four week study; changes will be examined in scores from baseline, at 1 week (mid-intervention), at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Secondary Outcome Measure Information:
Title
Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in mindfulness as measured by the Southampton Mindfulness Questionnaire
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in problem solving as measured by Social Problem Solving Inventory - Revised
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in attentional control as measured by the Random Interval Generation Task
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in attentional control as measured by the N-back task
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in worry frequency as measured by daily worry diaries
Time Frame
Worry measures completed daily during two week intervention period
Title
Change in meta cognitive beliefs about worry as measured by the Metacognitions Questionnaire-30
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in attentional control over worry as measured by the Breathing Focus Task
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in symptoms of depression as measured by the Depression, Anxiety, and Stress Scales - 21
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in symptoms of anxiety as measured by the Depression, Anxiety, and Stress Scales - 21
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in symptoms of insomnia as measured by the Insomnia Severity Index
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in health complaints as measured by the Subjective Health Complaints Questionnaire
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Title
Change in rumination as measured by the Ruminative Response Scales
Time Frame
This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endorse symptoms consistent with a primary diagnosis of Generalized Anxiety Disorder (GAD) as defined by DSM-5 (APA, 2013), with a clinician severity rating (CSR) ≥ 4 If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis. Exclusion Criteria: Have a 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 (meeting once monthly or less) or the participant has been receiving consistent weekly treatment for 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 psychotropic medication on an as needed basis (e.g., benzodiazepines), they will be included and their use of this medication will be noted in order to assess whether it has a moderating effect on intervention outcome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Tallon, MA
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request anonymized individual participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing anonymized 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.
Citations:
PubMed Identifier
6615390
Citation
Borkovec TD, Wilkinson L, Folensbee R, Lerman C. Stimulus control applications to the treatment of worry. Behav Res Ther. 1983;21(3):247-51. doi: 10.1016/0005-7967(83)90206-1. No abstract available.
Results Reference
background
Citation
Brosschot JF, Van Der Doef M. Daily worrying and somatic health complaints: Testing the effectiveness of a simple worry reduction intervention. Psychol Health. 2006; 21: 19-31. doi:10.1080/14768320500105346
Results Reference
background
PubMed Identifier
22977265
Citation
McGowan SK, Behar E. A preliminary investigation of stimulus control training for worry: effects on anxiety and insomnia. Behav Modif. 2013 Jan;37(1):90-112. doi: 10.1177/0145445512455661. Epub 2012 Sep 12.
Results Reference
background
Citation
Newman MG, Borkovec TD. Cognitive behavioral therapy for worry and generalized anxiety disorder. In: Simos G, editor. Cognitive behaviour therapy: A guide for the practising clinician. New York; Taylor & Francis; 2002. P 150-172.
Results Reference
background
Links:
URL
http://psychlabs.ryerson.ca/caplab/
Description
Lab website

Learn more about this trial

Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder

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