Training Mental Habits Study

An Experimental Investigation of the Effects of Concrete Thinking on Worry, Problem-Solving and Cognitive Processing in Individuals With Generalized Anxiety Disorder

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety; Worry
• Intervention / Treatment: Behavioral: Concreteness Training

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 2K3
      • Psychology Research and Training Centre, Ryerson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concreteness Training; 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.	Behavioral: Concreteness Training
No Intervention: Control; Assessment only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in worry as measured by the Penn State Worry Questionnaire - Past Week	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 Measures

Outcome Measure	Time Frame
Change in depressive symptoms as measured by the Centre for Epidemiological Studies Depression Scale	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in negative problem orientation as measured by the Negative Problem Orientation Questionnaire	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in quality of problem-solving as measured by The Means-Ends Problem-Solving task	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in problem solving style as measured by the Social Problem Solving Inventory Revised	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Change in attentional control as measured by the Attentional Control Scale	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in residual working memory capacity as measured by the Random Interval Generation Task	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
- Change in interpretation bias as measured by the Ambiguous/ Unambiguous Situations Diary Extended	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire	this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Change in worry as measured by experience sampling completed during the 7 days between baseline and post test	Daily during 7-day intervention period
Change in affect as measured by experience sampling completed during the 7 days between baseline and post test	Daily during 7-day intervention period
Change in concreteness as measured by experience sampling completed during the 7 days between baseline and post test.	Daily during 7-day intervention period
Change in GAD-Q-IV severity	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 Outcome Measures

Outcome Measure	Time Frame
Change in trait anxiety as measured by STICSA	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1 month follow up
Change in mood/affect as measured by PANAS	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up.
Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty Scale	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Change in emotion dysregulation as measured by the DERS	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Change in distress tolerance as measured by the Distress Tolerance Scale	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up
Change in imagery use as measured by the Spontaneous Use of Imagery Scale [	Administered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up

Collaborators and Investigators

• Sponsor: Ryerson University
• Collaborators: Canadian Institutes of Health Research (CIHR)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2015
• Primary Completion (Actual): October 28, 2019
• Study Completion (Actual): October 28, 2019

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Worry
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2015-146-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No