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
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2015
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedMarch 16, 2020
December 1, 2019
4.4 years
June 28, 2017
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
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
- +7 more secondary outcomes
Other Outcomes (6)
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
- +3 more other outcomes
Study Arms (2)
Concreteness Training
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONAssessment only.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychology Research and Training Centre, Ryerson University
Toronto, Ontario, M5B 2K3, Canada
Related Publications (3)
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.
PMID: 19222314BACKGROUNDBorkovec 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.
PMID: 2183759BACKGROUNDStöber, 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.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naomi Koerner, PhD
Toronto Metropolitan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Eligibility Assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
June 12, 2015
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
March 16, 2020
Record last verified: 2019-12