Generalized AnxietyNCT03205332
Training Mental Habits Study
A study testing Concreteness Training in people with Generalized Anxiety and Worry, run by Toronto Metropolitan University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety, Worry
- What is being tested?
- Concreteness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jun 2015to 28 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Psychology Research and Training Centre, Ryerson University
Toronto, Ontario, M5B 2K3
About this study
Official title: 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.
Read the 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.
- Conditions
- Generalized Anxiety, Worry
- Being tested
- Concreteness Training
- Keywords
- Worry, Anxiety
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concreteness TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Concreteness Training |
| Control | No intervention | Assessment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in worry as measured by the Penn State Worry Questionnaire - Past Week
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Daily during 7-day intervention period
Change in affect as measured by experience sampling completed during the 7 days between baseline and post test
Measured: Daily during 7-day intervention period
Change in concreteness as measured by experience sampling completed during the 7 days between baseline and post test.
Measured: Daily during 7-day intervention period
Change in GAD-Q-IV severity
Measured: this measure is administered at baseline, at post-test (1 week post baseline), at 1 week follow up and at 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start12 Jun 2015
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Naomi Koerner, Toronto Metropolitan University
- Investigators
- Naomi Koerner, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205332
- Sponsor's protocol ID
- 2015-146-1
- Status last verified
- Dec 2019
- First submitted
- 28 Jun 2017
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 19222314Borkovec 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.
PubMed 2183759Stöber, 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 at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Investigation of the Effects of Concrete Thinking on Worry, Problem-Solving and Cognitive Processing in Individuals With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03205332
- Acronym / sponsor ID
- 2015-146-1
- Conditions
- Generalized Anxiety, Worry
- Keywords
- Worry, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concreteness Training | Experimental | Behavioral: Concreteness TrainingParticipants 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 intervention | –Assessment only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concreteness Training | Behavioural | Concreteness Training |
Primary outcome
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
12 secondary outcomes
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
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
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
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
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
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
- 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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 19222314Watkins 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.
- Background: PubMed 2183759Borkovec 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.
- BackgroundStöber, 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Koerner, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concreteness Training in people with Generalized Anxiety and Worry, run by Toronto Metropolitan University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205332, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.