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Training Mental Habits Study

Primary Purpose

Generalized Anxiety, Worry

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

About this trial

This is an interventional treatment trial for Generalized Anxiety focused on measuring Worry, Anxiety

Eligibility Criteria

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

Inclusion:

  1. Penn State Worry Questionnaire (trait) score meeting threshold of 65 or higher.
  2. Endorsement of symptoms consistent with Generalized Anxiety Disorder on the MINI interview with a CSR equal to or greater than 4.
  3. If other symptoms are present, associated CSR is at least 1 point lower than the CSR associated with GAD symptoms

Exclusion

  1. Having a current or past history of mania or psychosis, or endorsement of symptoms consistent with a substance use disorder in the past 12 months.
  2. Reporting of suicidal ideation, intent or plan.
  3. Participants are excluded if they are currently receiving psychological treatment or counseling 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. Psychotropic medication with 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 in the case of fluoxetine.

Sites / Locations

  • Psychology Research and Training Centre, Ryerson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Concreteness Training

Control

Arm Description

Participants receive 1 session of training in concrete processing during the pre-intervention visit. They are then asked to engage in 30 minutes of concreteness practice daily, for 7 days.

Assessment only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in depressive symptoms as measured by the Centre for Epidemiological Studies Depression Scale
Change in negative problem orientation as measured by the Negative Problem Orientation Questionnaire
Change in quality of problem-solving as measured by The Means-Ends Problem-Solving task
Change in problem solving style as measured by the Social Problem Solving Inventory Revised
Change in attentional control as measured by the Attentional Control Scale
Change in residual working memory capacity as measured by the Random Interval Generation Task
- Change in interpretation bias as measured by the Ambiguous/ Unambiguous Situations Diary Extended
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Change in worry as measured by experience sampling completed during the 7 days between baseline and post test
Change in affect as measured by experience sampling completed during the 7 days between baseline and post test
Change in concreteness as measured by experience sampling completed during the 7 days between baseline and post test.
Change in GAD-Q-IV severity

Full Information

First Posted
June 28, 2017
Last Updated
March 13, 2020
Sponsor
Toronto Metropolitan University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03205332
Brief Title
Training Mental Habits Study
Official Title
An Experimental Investigation of the Effects of Concrete Thinking on Worry, Problem-Solving and Cognitive Processing in Individuals With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 12, 2015 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
October 28, 2019 (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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Generalized Anxiety Disorder (GAD) is a chronic condition whose hallmark feature is excessive and uncontrollable worry (American Psychiatric Association, 2013). Theories of GAD propose that specific cognitive biases are involved in the maintenance and etiology of chronic worry. One cognitive bias that plays a role in worrying is abstract thinking, or the tendency to "verbalize" thoughts and worries in a manner that is vague and lacking in detail. There is evidence that training depressed people to think more concretely improves depressive symptoms and depression-type thinking styles, and reduces emotional reactivity. Given that chronic worry and depression have commonalities (e.g., repetitive thinking styles, difficulties with problem-solving and attentional control, emotion dysregulation), concreteness training may help people who struggle with chronic worry. The main goals of this proof of concept experiment are 1) to test in individuals reporting chronic worry the effects of an active form of concreteness training that involves imagery practice (compared to a no training control condition) on frequency of worrying, problem solving quality, and worry-related processes; 2) to examine the degree to which concreteness training causes improvements in daily worry and negative affect during the 7 days of practice. The study design will provide us with an understanding on a more "macro" level of the potential short-term benefits and will at the same time allow us to see, on a more "micro" level, how training concreteness affects worry and mood on a day-to-day basis during a 7-day period. The findings from this study will inform relevant clinical literature about efficacious methods to reduce chronic worry.
Detailed Description
The main goals of this proof of concept experiment are 1) to test in individuals reporting chronic worry the effects of an active form of concreteness training that involves imagery practice (compared to a no training control condition) on frequency of worrying, problem solving quality, and worry-related processes; 2) to examine the degree to which concreteness training causes improvements in daily worry and negative affect during the 7 days of practice. Participants are recruited from the community via advertisements. Following a telephone screen, participants attend a baseline visit during which they complete the MINI interview. Those who continue to be eligible complete the outcome measures and are randomly assigned to either the experimental condition or the control condition. Participants assigned to the experimental condition receive training in concrete processing and learn how to complete the daily experience sampling diary. Participants assigned to the control condition do not receive training and learn how to complete the daily experience sampling diary. All participants then complete their assigned activities for 7 days. They then return to the lab to complete the outcome measures at post-test, 1 week follow up and 1 month follow up. Participants are then debriefed.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Eligibility Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concreteness Training
Arm Type
Experimental
Arm Description
Participants receive 1 session of training in concrete processing during the pre-intervention visit. They are then asked to engage in 30 minutes of concreteness practice daily, for 7 days.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment only.
Intervention Type
Behavioral
Intervention Name(s)
Concreteness Training
Primary Outcome Measure Information:
Title
Change in worry as measured by the Penn State Worry Questionnaire - Past Week
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Secondary Outcome Measure Information:
Title
Change in depressive symptoms as measured by the Centre for Epidemiological Studies Depression Scale
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in negative problem orientation as measured by the Negative Problem Orientation Questionnaire
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in quality of problem-solving as measured by The Means-Ends Problem-Solving task
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in problem solving style as measured by the Social Problem Solving Inventory Revised
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Title
Change in attentional control as measured by the Attentional Control Scale
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in residual working memory capacity as measured by the Random Interval Generation Task
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
- Change in interpretation bias as measured by the Ambiguous/ Unambiguous Situations Diary Extended
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Title
Change in worry as measured by experience sampling completed during the 7 days between baseline and post test
Time Frame
Daily during 7-day intervention period
Title
Change in affect as measured by experience sampling completed during the 7 days between baseline and post test
Time Frame
Daily during 7-day intervention period
Title
Change in concreteness as measured by experience sampling completed during the 7 days between baseline and post test.
Time Frame
Daily during 7-day intervention period
Title
Change in GAD-Q-IV severity
Time Frame
this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Other Pre-specified Outcome Measures:
Title
Change in trait anxiety as measured by STICSA
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1 month follow up
Title
Change in mood/affect as measured by PANAS
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up.
Title
Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Title
Change in emotion dysregulation as measured by the DERS
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Title
Change in distress tolerance as measured by the Distress Tolerance Scale
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Title
Change in imagery use as measured by the Spontaneous Use of Imagery Scale [
Time Frame
Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month 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: Penn State Worry Questionnaire (trait) score meeting threshold of 65 or higher. Endorsement of symptoms consistent with Generalized Anxiety Disorder on the MINI interview with a CSR equal to or greater than 4. If other symptoms are present, associated CSR is at least 1 point lower than the CSR associated with GAD symptoms Exclusion Having a current or past history of mania or psychosis, or endorsement of symptoms consistent with a substance use disorder in the past 12 months. Reporting of suicidal ideation, intent or plan. Participants are excluded if they are currently receiving psychological treatment or counseling 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. Psychotropic medication with 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 in the case of fluoxetine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Koerner, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychology Research and Training Centre, Ryerson University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 2K3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19222314
Citation
Watkins ER, Baeyens CB, Read R. Concreteness training reduces dysphoria: proof-of-principle for repeated cognitive bias modification in depression. J Abnorm Psychol. 2009 Feb;118(1):55-64. doi: 10.1037/a0013642.
Results Reference
background
PubMed Identifier
2183759
Citation
Borkovec TD, Inz J. The nature of worry in generalized anxiety disorder: a predominance of thought activity. Behav Res Ther. 1990;28(2):153-8. doi: 10.1016/0005-7967(90)90027-g.
Results Reference
background
Citation
Stöber, J. & Borkovec, T.D. (2002). Reduced concreteness of worry in generalized anxiety disorder: Findings from a therapy study. Cognitive Therapy and Research, 26, 89 - 95.
Results Reference
background

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Training Mental Habits Study

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