Excessive WorryNCT03654625
Development of a Scientifically Informed Written Exposure Procedure (The SCRIPTS Study)
A study testing Standard Written Exposure and Enhanced Written Exposure in people with Excessive Worry, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. When people with GAD worry, they tend to think about problems and feared situations in a vague way. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Excessive Worry
- What is being tested?
- Standard Written Exposure and Enhanced Written Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2018to 31 Dec 2020
- 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
- Score of 56 or higher on the Penn State Worry Questionnaire.
- Endorsement of Generalized Anxiety Disorder as per the DSM-5 description (American Psychiatric Association, 2013).
Who cannot join
- Clinically significant suicidal ideation, intent, or plan
- Past or current history of psychosis or mania, or substance use disorder over the past 12 months
- Current psychological treatment or counseling unless this treatment is infrequent (once monthly or less) or the participant has been receiving consistent weekly treatment for at least 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 if they had been taking fluoxetine.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ryerson University
Toronto, Ontario, M5B 2K3
Naomi Koerner, PhD, 416-979-5000 ext. 2151, naomi.koerner@psych.ryerson.ca
About this study
Official title: Development of a Scientifically-Informed Written Exposure Procedure (The SCRIPTS Study)
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety. When people with GAD worry, they tend to think about problems and feared situations in a vague way. Preliminary research suggests that writing about feared situations in a structured and detailed fashion may help with worry. In this experiment, the investigators are looking to improve the writing intervention. The investigators are testing the immediate and short-term effects of a new writing intervention.
Read the detailed description
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety about bad things that may happen in the future. When people with GAD worry, they tend to think about the situations they fear in a vague way. Preliminary research suggests that writing repeatedly about one's fears in a structured and detailed way may help worry. In the present experiment, the investigators are comparing three structured writing interventions and testing their immediate and short-term effects on worry, and worry-related features.
Potential participants will be asked to complete a telephone screen. Those who meet eligibility criteria will be invited to the laboratory at Ryerson University. After completing pre-intervention outcome measures, participants will be randomly assigned to one of three writing interventions: (1) standard written exposure, (2) enhanced written exposure, or (3) neutral writing. All participants will write for 30 minutes on each of 4 days. The 4 sessions of writing will be spaced and will take place within a period of 2 weeks. Excessive worry will be assessed at pre-intervention, mid-intervention, post-intervention, 1-week follow-up and 1 month follow-up. With the exception of the Modified Behavioural Avoidance Test, which will only be assessed at pre-intervention and 1 month follow-up, all other outcomes will be assessed at pre-intervention, and at post-intervention, 1-week follow-up and 1 month follow-up. Additional assessments of Perceived Probability, Cost and Coping Questions will occur at each writing session.
During the 2-week intervention period and the three days following the intervention period, all participants will also track their worry and mood twice per day.
The present experiment will provide answers to important questions about the therapeutic potential of writing interventions for excessive worry.
- Conditions
- Excessive Worry
- Being tested
- Standard Written Exposure, Enhanced Written Exposure, Control Condition
- Keywords
- Worry, Anxiety, Generalized Anxiety Disorder, Written Exposure
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Written ExposureBehavioural
Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry.
Enhanced Written ExposureBehavioural
Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry and rescript it.
Control ConditionBehavioural
Four spaced, 30-minute sessions occurring within a period of 2 weeks. At each session, participants write a narrative about a neutral topic.
| Study group | Role | What they receive |
|---|---|---|
| Standard Written Exposure | Experimental | Four writing sessions at the laboratory Receives: Behavioral: Standard Written Exposure |
| Enhanced Written Exposure | Experimental | Four writing sessions at the laboratory Receives: Behavioral: Enhanced Written Exposure |
| Control Condition | Placebo comparator | Four writing sessions at the laboratory Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
Self-report measure assessing the degree of excessive worry experienced over the past week. Fifteen items are summed to create a total score. Scores range from 0 to 90, with greater scores indicating a greater degree of worry.
Measured: Administered before the intervention on day 1 (pre-intervention), within week 2 of the intervention (at writing session 3), post-intervention (3 days after writing session 4), 1-week follow-up and 1-month follow-up.
Secondary outcomes (12)
Self-reported generalized anxiety disorder symptoms as measured by the Generalized Anxiety Disorder Questionnaire for the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV.
Self-report measure of GAD symptoms. Fourteen items are summed to create a total score. Total scores range from 0 to 12, with greater scores indicating greater GAD symptom severity.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Self-report measure of the tendency to engage in various cognitive avoidance strategies. Twenty-five items are summed to create a total score. Total scores range from 25 to 125, with higher scores indicating greater cognitive avoidance.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported attitudes towards problems as measured by the Negative Problem Orientation Questionnaire
Self-report measure of attitudes towards problems. Twelve items are summed to create a total score. Total scores range from 12 to 60, with higher scores indicating greater negative attitudes towards problems.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported fear of emotions as measured by the Affective Control Scale
Self-report measure of fear of emotions and attempts to control emotional experience. The scale contains 42 items divided into four subscales for distinct emotions: anxiety; depression; anger; positive emotion. Total scores range from 42 to 294; subscale scores range from 13 to 91, with higher scores indicating a greater fear of emotions.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported perceptions of shame as measured by the Shame-Aversive Reactions Questionnaire
Self-report measure of perception of shame as an undesirable and painful emotion. Fourteen items are summed to create a total score. Total scores range from 14 to 98, with higher scores indicating higher levels of shame aversion.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported maladaptive beliefs as measured by the Early Maladaptive Schema Questionnaire - Research version
Self-report measure of stable maladaptive beliefs. The scale contains 75 items divided into fifteen subscales for distinct maladaptive beliefs. Subscale scores range from 0 to 15, with higher scores indicating greater maladaptive beliefs.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported worry-related behaviours as measured by the Worry Behaviours Inventory
Self-report measure of worry-related behaviours. Ten items are summed to create a total score. Total scores range from 0 to 40, with higher scores indicating greater engagement in avoidant behaviors that are associated with worry.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported mastery as measured by the Self-Mastery scale
Self-report measure that assesses the extent to which an individual perceives a sense of personal control or mastery over life outcomes. Seven items are summed to create a total score. Total scores range from 7 to 49, with higher scores indicating greater personal control or mastery.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported Perceived probability, cost and coping as measured by Perceived Probability, Cost and Coping questions
Self-report measure of perceptions of probability and costliness of, and ability to cope with one's feared scenario. Three distinct questions assess each of the following perceptions related to feared scenarios: 1) Probability, 2) Cost and 3) Coping. Perceived probability scores range from 0 to 6 with higher scores indicating greater perceived likelihood of worst fears coming true. Perceived costliness scores range from 0 to 6, with higher scores indicating greater perceived costliness of worst fears. Perceived coping scores range from 0 to 6, with greater scores indicating greater ability to cope.
Measured: Administered before the intervention on day 1, within week 1 of the intervention (at writing session 2), within week 2 of the intervention (writing sessions 3 and 4), post-intervention (3 days after writing session 4), and 1-week and 1-month follow-up.
Fear and avoidance related to worst case scenario as measured by the Modified Behavioural Avoidance Test
Participants are asked to hold a mental image in mind of their hypothetical worst case scenario and rate their level of fear from 0 (no fear at all) to 10 (the most fear), and desire to avoid the mental image from 0 (no desire to avoid imagining) to 10 (the highest possible desire to avoid imagining).
Measured: Administered before the intervention on day 1 (pre-intervention) and 1-month follow-up.
Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale
Self-report measure that assesses depression, anxiety and stress symptoms over the past week. The scale contains 21 items, divided into three subscales: 1) Depression, 2) Anxiety and 3) Stress. Scores on the subscales range from 0 to 42, with higher scores indicating greater severity of depression, anxiety and stress.
Measured: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Daily Worry and Emotion Questions
A daily self-report measure of (1) emotions, (2) worry controllability, (3) worry intensity and (4) worry duration.
Scores for the first three items range from 0 to 8, with higher scores indicating greater degree of emotions, worry intensity, and difficulty controlling worry. Worry duration is reported in minutes, with greater numbers indicating longer time spent worrying.
Measured: During the two-week intervention period and for three days following the intervention period, all participants are asked to respond to questions about their worry and emotions twice per day (morning and evening) using an online diary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start7 Sep 2018
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive WorryStudies 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
- Model description
- Baseline (pre-intervention) outcome measures will be completed at the first visit to the lab at Ryerson University. Participants will then be randomly assigned to one of the following conditions: (1) standard written exposure, (2) enhanced written exposure or (3) neutral writing. All participants will write at the lab for 30 minutes on each of 4 days. The 4 writing sessions will be spaced and take place within a 2-week period. During the 2-week intervention period and the three days following the intervention period, participants will track their worry and mood twice per day. With the exception of the Modified Behavioural Avoidance Test, which will only be assessed at pre-intervention and 1 month follow-up , all other outcomes will be reassessed at post-intervention, 1-week and 1-month follow-up. An additional assessment of excessive worry will occur at mid-intervention, and additional assessments of Perceived Probability, Cost and Coping Questions will occur at each writing session.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ministry of Research, Innovation and Science, Ontario
- 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
- NCT03654625
- Sponsor's protocol ID
- REB 2018-094
- Status last verified
- Mar 2020
- First submitted
- 11 Aug 2018
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, anonymized aggregate 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 curricula vitae (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. No individual data will be shared.
Publications
Fracalanza K, Koerner N, Antony MM. Testing a procedural variant of written imaginal exposure for generalized anxiety disorder. J Anxiety Disord. 2014 Aug;28(6):559-69. doi: 10.1016/j.janxdis.2014.05.011. Epub 2014 Jun 14.
PubMed 24983797
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
- Development of a Scientifically-Informed Written Exposure Procedure (The SCRIPTS Study)
- ClinicalTrials.gov ID
- NCT03654625
- Acronym / sponsor ID
- REB 2018-094
- Conditions
- Excessive Worry
- Keywords
- Worry, Anxiety, Generalized Anxiety Disorder, Written Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ministry of Research, Innovation and Science, Ontario
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Aug 2018 (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 characterized by excessive and uncontrollable worry and anxiety. When people with GAD worry, they tend to think about problems and feared situations in a vague way. Preliminary research suggests that writing about feared situations in a structured and detailed fashion may help with worry. In this experiment, the investigators are looking to improve the writing intervention. The investigators are testing the immediate and short-term effects of a new writing intervention.
Detailed description
Generalized anxiety disorder (GAD) is characterized by excessive and uncontrollable worry and anxiety about bad things that may happen in the future. When people with GAD worry, they tend to think about the situations they fear in a vague way. Preliminary research suggests that writing repeatedly about one's fears in a structured and detailed way may help worry. In the present experiment, the investigators are comparing three structured writing interventions and testing their immediate and short-term effects on worry, and worry-related features.
Potential participants will be asked to complete a telephone screen. Those who meet eligibility criteria will be invited to the laboratory at Ryerson University. After completing pre-intervention outcome measures, participants will be randomly assigned to one of three writing interventions: (1) standard written exposure, (2) enhanced written exposure, or (3) neutral writing. All participants will write for 30 minutes on each of 4 days. The 4 sessions of writing will be spaced and will take place within a period of 2 weeks. Excessive worry will be assessed at pre-intervention, mid-intervention, post-intervention, 1-week follow-up and 1 month follow-up. With the exception of the Modified Behavioural Avoidance Test, which will only be assessed at pre-intervention and 1 month follow-up, all other outcomes will be assessed at pre-intervention, and at post-intervention, 1-week follow-up and 1 month follow-up. Additional assessments of Perceived Probability, Cost and Coping Questions will occur at each writing session.
During the 2-week intervention period and the three days following the intervention period, all participants will also track their worry and mood twice per day.
The present experiment will provide answers to important questions about the therapeutic potential of writing interventions for excessive worry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Baseline (pre-intervention) outcome measures will be completed at the first visit to the lab at Ryerson University. Participants will then be randomly assigned to one of the following conditions: (1) standard written exposure, (2) enhanced written exposure or (3) neutral writing. All participants will write at the lab for 30 minutes on each of 4 days. The 4 writing sessions will be spaced and take place within a 2-week period. During the 2-week intervention period and the three days following the intervention period, participants will track their worry and mood twice per day. With the exception of the Modified Behavioural Avoidance Test, which will only be assessed at pre-intervention and 1 month follow-up , all other outcomes will be reassessed at post-intervention, 1-week and 1-month follow-up. An additional assessment of excessive worry will occur at mid-intervention, and additional assessments of Perceived Probability, Cost and Coping Questions will occur at each writing session.
| Arm | Type | Receives |
|---|---|---|
| Standard Written Exposure | Experimental | Behavioral: Standard Written ExposureFour writing sessions at the laboratory |
| Enhanced Written Exposure | Experimental | Behavioral: Enhanced Written ExposureFour writing sessions at the laboratory |
| Control Condition | Placebo comparator | Behavioral: Control ConditionFour writing sessions at the laboratory |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Score of 56 or higher on the Penn State Worry Questionnaire.
- Endorsement of Generalized Anxiety Disorder as per the DSM-5 description (American Psychiatric Association, 2013).
Key exclusion criteria (4 listed)
- Clinically significant suicidal ideation, intent, or plan
- Past or current history of psychosis or mania, or substance use disorder over the past 12 months
- Current psychological treatment or counseling unless this treatment is infrequent (once monthly or less) or the participant has been receiving consistent weekly treatment for at least 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 if they had been taking 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 |
|---|---|---|
| Standard Written ExposureFour spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry. | Behavioural | Standard Written Exposure |
| Enhanced Written ExposureFour spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry and rescript it. | Behavioural | Enhanced Written Exposure |
| Control ConditionFour spaced, 30-minute sessions occurring within a period of 2 weeks. At each session, participants write a narrative about a neutral topic. | Behavioural | Control Condition |
Primary outcome
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
Time frame: Administered before the intervention on day 1 (pre-intervention), within week 2 of the intervention (at writing session 3), post-intervention (3 days after writing session 4), 1-week follow-up and 1-month follow-up.
Self-report measure assessing the degree of excessive worry experienced over the past week. Fifteen items are summed to create a total score. Scores range from 0 to 90, with greater scores indicating a greater degree of worry.
12 secondary outcomes
Self-reported generalized anxiety disorder symptoms as measured by the Generalized Anxiety Disorder Questionnaire for the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV.
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported attitudes towards problems as measured by the Negative Problem Orientation Questionnaire
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported fear of emotions as measured by the Affective Control Scale
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported perceptions of shame as measured by the Shame-Aversive Reactions Questionnaire
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported maladaptive beliefs as measured by the Early Maladaptive Schema Questionnaire - Research version
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported worry-related behaviours as measured by the Worry Behaviours Inventory
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported mastery as measured by the Self-Mastery scale
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Self-reported Perceived probability, cost and coping as measured by Perceived Probability, Cost and Coping questions
Time frame: Administered before the intervention on day 1, within week 1 of the intervention (at writing session 2), within week 2 of the intervention (writing sessions 3 and 4), post-intervention (3 days after writing session 4), and 1-week and 1-month follow-up.
Fear and avoidance related to worst case scenario as measured by the Modified Behavioural Avoidance Test
Time frame: Administered before the intervention on day 1 (pre-intervention) and 1-month follow-up.
Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale
Time frame: Administered before the intervention on day 1 (pre-intervention), post-intervention (3 days after writing session 4), 1-week follow-up, and 1-month follow-up.
Daily Worry and Emotion Questions
Time frame: During the two-week intervention period and for three days following the intervention period, all participants are asked to respond to questions about their worry and emotions twice per day (morning and evening) using an online diary.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 24983797Fracalanza K, Koerner N, Antony MM. Testing a procedural variant of written imaginal exposure for generalized anxiety disorder. J Anxiety Disord. 2014 Aug;28(6):559-69. doi: 10.1016/j.janxdis.2014.05.011. Epub 2014 Jun 14.
- Lab websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Results of the study will be disseminated via conference presentations, journal publications, and through our lab website. Upon request, anonymized aggregate 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 curricula vitae (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. No individual data will be shared.
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 Standard Written Exposure and Enhanced Written Exposure in people with Excessive 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 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: status not confirmed, 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Koerner, PhD (416-979-5000 ext. 2151, naomi.koerner@psych.ryerson.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version (time frame: Administered before the intervention on day 1 (pre-intervention), within week 2 of the intervention (at writing session 3), post-intervention (3 days after writing session 4), 1-week follow-up and 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 NCT03654625, which also lists 1 linked publication.
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.