NCT03205332

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2019

Completed
Last Updated

March 16, 2020

Status Verified

December 1, 2019

Enrollment Period

4.4 years

First QC Date

June 28, 2017

Last Update Submit

March 13, 2020

Conditions

Keywords

WorryAnxiety

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

EXPERIMENTAL

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

Control

NO INTERVENTION

Assessment only.

Interventions

Concreteness Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 19222314BACKGROUND
  • 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.

    PMID: 2183759BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Naomi Koerner, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

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

Locations