Generalized Anxiety DisorderNCT02806271
Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
A study testing Worry Postponement and Worry Monitoring in people with Generalized Anxiety Disorder, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Worry Postponement and Worry Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Jul 2018
- 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
- Endorse symptoms consistent with a primary diagnosis of Generalized Anxiety Disorder (GAD) as defined by DSM-5 (APA, 2013), with a clinician severity rating (CSR) ≥ 4
- If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis.
Who cannot join
- Have a current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
- Report clinically significant suicidal ideation, intent, or plan
- Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), 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
- Are taking psychotropic medications and have had 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 if they had been taking fluoxetine/Prozac. If a participant is taking psychotropic medication on an as needed basis (e.g., benzodiazepines), they will be included and their use of this medication will be noted in order to assess whether it has a moderating effect on intervention outcome.
Trial locations and contacts
1 site in 1 country.
About this study
Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Despite being commonly recommended, there is little known about the efficacy and mechanisms of worry postponement. The purpose of this study is to determine the efficacy and mechanisms of change of a two-week worry postponement intervention in people with Generalized Anxiety Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only control condition. Changes in worry or associated features will be examined at post intervention and at a 2-week follow up.
Read the detailed description
Generalized Anxiety Disorder (GAD) is a disorder characterized by excessive and uncontrollable worry. People with GAD report that worry significantly interferes with their ability to enjoy their life and function effectively in their roles. Worry postponement is a treatment technique developed by Borkovec and colleagues (1983) to reduce excessive worry. In worry postponement, people are instructed to notice naturally occurring episodes of worry and to then disengage from their worry and postpone it to a designated 30 minute "worry period" later in the day. People are instructed to confine their worry to this 30 minute period and to use that period to problem solve concerns they have been having. Worry postponement is a widely recommended technique for treating excessive worry in people with GAD and is often combined with other cognitive-behavioural interventions. Despite being commonly recommended, there are very few studies demonstrating worry postponement's efficacy for reducing worry, and no studies have looked at the effect of this intervention in people with GAD. The present study aims to extend the literature by comparing a two-week worry postponement intervention to worry monitoring alone and to an assessment only control condition. Participants will complete baseline self-report measures of worry and associated symptoms and cognitive processes. They will complete three computer tasks measuring attention control. They will then be randomized to one of three conditions (worry postponement, worry monitoring, assessment only control). Participants will follow instructions corresponding to their condition daily for two weeks. In the worry postponement and worry monitoring conditions this will involve completing brief daily worry questionnaires at home for the two weeks of the intervention. In the assessment only condition participants will not complete any measures during the two weeks after the first session. Subsequent to this, all participants will return to the lab to repeat baseline measures, and will return again two weeks later to complete measures. The entire study will require three lab visits, spanning over four weeks. This study aims to determine what the effects of worry postponement are, relative to worry monitoring and assessment only, on worry, GAD and associated symptoms, and cognitive processes related to worry. A secondary aim of this study is to examine which mechanisms predict change in worry in a worry postponement study. This will be the first study to our knowledge, to examine these questions in a sample of people with GAD. This study will provide important information for optimizing the treatment of worry in people with GAD.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Worry Postponement, Worry Monitoring
- Keywords
- Worry Postponement, Stimulus Control
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worry PostponementBehavioural
Also called Stimulus Control for Worry
In worry postponement, participants are instructed to learn to notice naturally occurring episodes of worry. When they notice they are worrying they are instructed to disengage from their worry and postpone it to a designated 30 minute "worry period" to be carried out at the same time and place daily during the two week intervention. Participants are to use their worry time to worry about problems that have come up during the day and to problem solve where appropriate.
Worry MonitoringBehavioural
For two weeks participants are instructed to monitor their worry using a smartphone based application. Participants are instructed to make a record each time they have a worry episode by briefly describing the content of their worry. Participants also complete two brief daily questionnaires about the duration of their worry, the intensity of their worry, their ability to disengage from their worry, and the occurrence of nighttime episodes of worry.
| Study group | Role | What they receive |
|---|---|---|
| Worry Postponement | Experimental | Two weeks of daily worry postponement Receives: Behavioral: Worry Postponement; Behavioral: Worry Monitoring |
| Worry Monitoring | Active comparator | Two weeks of daily worry monitoring Receives: Behavioral: Worry Monitoring |
| Assessment Only Control | No intervention | No intervention, participants will complete three assessment time points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in worry as measures by the Penn State Worry Questionnaire - Past Week
Measured: This measure will be administered four times over the course of the four week study; changes will be examined in scores from baseline, at 1 week (mid-intervention), at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Secondary outcomes (14)
Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in mindfulness as measured by the Southampton Mindfulness Questionnaire
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in problem solving as measured by Social Problem Solving Inventory - Revised
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control as measured by the Random Interval Generation Task
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control as measured by the N-back task
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in worry frequency as measured by daily worry diaries
Measured: Worry measures completed daily during two week intervention period
Change in meta cognitive beliefs about worry as measured by the Metacognitions Questionnaire-30
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control over worry as measured by the Breathing Focus Task
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of depression as measured by the Depression, Anxiety, and Stress Scales - 21
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of anxiety as measured by the Depression, Anxiety, and Stress Scales - 21
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of insomnia as measured by the Insomnia Severity Index
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in health complaints as measured by the Subjective Health Complaints Questionnaire
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in rumination as measured by the Ruminative Response Scales
Measured: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 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, Kathleen Tallon, Toronto Metropolitan University
- Investigators
- Kathleen Tallon, MA, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806271
- Sponsor's protocol ID
- 2016 - 143
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request anonymized individual participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing anonymized data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal.
Publications
Borkovec TD, Wilkinson L, Folensbee R, Lerman C. Stimulus control applications to the treatment of worry. Behav Res Ther. 1983;21(3):247-51. doi: 10.1016/0005-7967(83)90206-1. No abstract available.
PubMed 6615390Brosschot JF, Van Der Doef M. Daily worrying and somatic health complaints: Testing the effectiveness of a simple worry reduction intervention. Psychol Health. 2006; 21: 19-31. doi:10.1080/14768320500105346
McGowan SK, Behar E. A preliminary investigation of stimulus control training for worry: effects on anxiety and insomnia. Behav Modif. 2013 Jan;37(1):90-112. doi: 10.1177/0145445512455661. Epub 2012 Sep 12.
PubMed 22977265Newman MG, Borkovec TD. Cognitive behavioral therapy for worry and generalized anxiety disorder. In: Simos G, editor. Cognitive behaviour therapy: A guide for the practising clinician. New York; Taylor & Francis; 2002. P 150-172.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Efficacy and Mechanisms of Change of a Worry Postponement Intervention for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02806271
- Acronym / sponsor ID
- 2016 - 143
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Worry Postponement, Stimulus Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
Worry postponement is a commonly recommended treatment component in cognitive behavioral therapy for Generalized Anxiety Disorder in which people are asked to postpone naturally occurring instances of worry to a designated 30 minute "worry period" later in the day. Despite being commonly recommended, there is little known about the efficacy and mechanisms of worry postponement. The purpose of this study is to determine the efficacy and mechanisms of change of a two-week worry postponement intervention in people with Generalized Anxiety Disorder. Ninety subjects with generalized anxiety disorder will be randomly assigned to two weeks of daily worry postponement, two weeks of worry monitoring, or an assessment only control condition. Changes in worry or associated features will be examined at post intervention and at a 2-week follow up.
Detailed description
Generalized Anxiety Disorder (GAD) is a disorder characterized by excessive and uncontrollable worry. People with GAD report that worry significantly interferes with their ability to enjoy their life and function effectively in their roles. Worry postponement is a treatment technique developed by Borkovec and colleagues (1983) to reduce excessive worry. In worry postponement, people are instructed to notice naturally occurring episodes of worry and to then disengage from their worry and postpone it to a designated 30 minute "worry period" later in the day. People are instructed to confine their worry to this 30 minute period and to use that period to problem solve concerns they have been having. Worry postponement is a widely recommended technique for treating excessive worry in people with GAD and is often combined with other cognitive-behavioural interventions. Despite being commonly recommended, there are very few studies demonstrating worry postponement's efficacy for reducing worry, and no studies have looked at the effect of this intervention in people with GAD. The present study aims to extend the literature by comparing a two-week worry postponement intervention to worry monitoring alone and to an assessment only control condition. Participants will complete baseline self-report measures of worry and associated symptoms and cognitive processes. They will complete three computer tasks measuring attention control. They will then be randomized to one of three conditions (worry postponement, worry monitoring, assessment only control). Participants will follow instructions corresponding to their condition daily for two weeks. In the worry postponement and worry monitoring conditions this will involve completing brief daily worry questionnaires at home for the two weeks of the intervention. In the assessment only condition participants will not complete any measures during the two weeks after the first session. Subsequent to this, all participants will return to the lab to repeat baseline measures, and will return again two weeks later to complete measures. The entire study will require three lab visits, spanning over four weeks. This study aims to determine what the effects of worry postponement are, relative to worry monitoring and assessment only, on worry, GAD and associated symptoms, and cognitive processes related to worry. A secondary aim of this study is to examine which mechanisms predict change in worry in a worry postponement study. This will be the first study to our knowledge, to examine these questions in a sample of people with GAD. This study will provide important information for optimizing the treatment of worry in people with GAD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Worry Postponement | Experimental | Behavioral: Worry Postponement, Behavioral: Worry MonitoringTwo weeks of daily worry postponement |
| Worry Monitoring | Active comparator | Behavioral: Worry MonitoringTwo weeks of daily worry monitoring |
| Assessment Only Control | No intervention | –No intervention, participants will complete three assessment time points |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endorse symptoms consistent with a primary diagnosis of Generalized Anxiety Disorder (GAD) as defined by DSM-5 (APA, 2013), with a clinician severity rating (CSR) ≥ 4
- If a comorbid diagnosis is present, its associated CSR is at least 1 point lower than that of their GAD diagnosis.
Key exclusion criteria (4 listed)
- Have a current or past history of psychosis or mania, or endorse symptoms consistent with a diagnosis of a substance use disorder in the past 12 months
- Report clinically significant suicidal ideation, intent, or plan
- Participants will be excluded if they are currently receiving psychological treatment or counseling (e.g., cognitive behaviour therapy, supportive counseling, etc.), 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
- Are taking psychotropic medications and have had 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 if they had been taking fluoxetine/Prozac. If a participant is taking psychotropic medication on an as needed basis (e.g., benzodiazepines), they will be included and their use of this medication will be noted in order to assess whether it has a moderating effect on intervention outcome.
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 |
|---|---|---|
| Worry PostponementAlso: Stimulus Control for WorryIn worry postponement, participants are instructed to learn to notice naturally occurring episodes of worry. When they notice they are worrying they are instructed to disengage from their worry and postpone it to a designated 30 minute "worry period" to be carried out at the same time and place daily during the two week intervention. Participants are to use their worry time to worry about problems that have come up during the day and to problem solve where appropriate. | Behavioural | Worry Postponement |
| Worry MonitoringFor two weeks participants are instructed to monitor their worry using a smartphone based application. Participants are instructed to make a record each time they have a worry episode by briefly describing the content of their worry. Participants also complete two brief daily questionnaires about the duration of their worry, the intensity of their worry, their ability to disengage from their worry, and the occurrence of nighttime episodes of worry. | Behavioural | Worry Monitoring, Worry Postponement |
Primary outcome
Change in worry as measures by the Penn State Worry Questionnaire - Past Week
Time frame: This measure will be administered four times over the course of the four week study; changes will be examined in scores from baseline, at 1 week (mid-intervention), at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
14 secondary outcomes
Change in mindfulness the Cognitive and Affective Mindfulness Scale-Revised
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in mindfulness as measured by the Southampton Mindfulness Questionnaire
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in problem solving as measured by Social Problem Solving Inventory - Revised
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control as measured by the Random Interval Generation Task
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control as measured by the N-back task
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in worry frequency as measured by daily worry diaries
Time frame: Worry measures completed daily during two week intervention period
Change in meta cognitive beliefs about worry as measured by the Metacognitions Questionnaire-30
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in attentional control over worry as measured by the Breathing Focus Task
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of depression as measured by the Depression, Anxiety, and Stress Scales - 21
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of anxiety as measured by the Depression, Anxiety, and Stress Scales - 21
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in symptoms of insomnia as measured by the Insomnia Severity Index
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in health complaints as measured by the Subjective Health Complaints Questionnaire
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week follow-up)
Change in rumination as measured by the Ruminative Response Scales
Time frame: This measure will be administered three times over the course of the four week study; changes will be examined in scores from baseline, at 2 weeks (immediately post intervention), and at 4 weeks (2 week 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 19 Jul 2018.
- Background: PubMed 6615390Borkovec TD, Wilkinson L, Folensbee R, Lerman C. Stimulus control applications to the treatment of worry. Behav Res Ther. 1983;21(3):247-51. doi: 10.1016/0005-7967(83)90206-1. No abstract available.
- BackgroundBrosschot JF, Van Der Doef M. Daily worrying and somatic health complaints: Testing the effectiveness of a simple worry reduction intervention. Psychol Health. 2006; 21: 19-31. doi:10.1080/14768320500105346
- Background: PubMed 22977265McGowan SK, Behar E. A preliminary investigation of stimulus control training for worry: effects on anxiety and insomnia. Behav Modif. 2013 Jan;37(1):90-112. doi: 10.1177/0145445512455661. Epub 2012 Sep 12.
- BackgroundNewman MG, Borkovec TD. Cognitive behavioral therapy for worry and generalized anxiety disorder. In: Simos G, editor. Cognitive behaviour therapy: A guide for the practising clinician. New York; Taylor & Francis; 2002. P 150-172.
- Lab websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request anonymized individual participant data may be made available to a publishing journal or individual research group. Individual research groups interested in accessing anonymized data will be required to submit a proposal detailing their intended use of the data. Their qualifications will be reviewed based on their proposal and CVs. Individual research groups approved for access will be required to agree to not attempt to re-identify participants, not further distribute data, and not use the data for purposes other than specified in their original proposal.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
Kathleen Tallon, MA 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 Worry Postponement and Worry Monitoring in people with Generalized Anxiety Disorder, 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 2 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 19 Jul 2018. 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 measures by the Penn State Worry Questionnaire - Past Week (time frame: This measure will be administered four times over the course of the four week study; changes will be examined in scores from baseline, at 1 week (mid-intervention), at 2 weeks (immediately post intervention), and at 4 weeks (2 week 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 NCT02806271, which also lists 4 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 19 Jul 2018.