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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03205332
Enrollment
121
Registered
2017-07-02
Start date
2015-06-12
Completion date
2019-10-28
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety, Worry

Keywords

Worry, Anxiety

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.

Interventions

BEHAVIORALConcreteness Training

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Toronto Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Eligibility Assessor

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change in worry as measured by the Penn State Worry Questionnaire - Past Weekthis measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up

Secondary

MeasureTime frame
Change in problem solving style as measured by the Social Problem Solving Inventory RevisedAdministered 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 Extendedthis 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 Questionnairethis 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 testDaily during 7-day intervention period
Change in affect as measured by experience sampling completed during the 7 days between baseline and post testDaily 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 severitythis 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 depressive symptoms as measured by the Centre for Epidemiological Studies Depression Scalethis 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 Questionnairethis 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 taskthis 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 attentional control as measured by the Attentional Control Scalethis 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 Taskthis measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up

Other

MeasureTime frame
Change in intolerance of uncertainty as measured by the Intolerance of Uncertainty ScaleAdministered 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 DERSAdministered 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 ScaleAdministered 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
Change in mood/affect as measured by PANASAdministered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1-month follow up.
Change in trait anxiety as measured by STICSAAdministered at baseline, at post-test (1 week post baseline), at 1-week follow up and at 1 month follow up

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026