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Completed

NCT Number: NCT03205332

Training Mental Habits Study

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.

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Key information

Conditions

Generalized Anxiety Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Worry

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychology Research and Training Centre, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Concreteness Training

Behavioral

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. - 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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