Development of a Scientifically Informed Written Exposure Procedure (The SCRIPTS Study) (NCT03654625) | Clinical Trial Compass
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Development of a Scientifically Informed Written Exposure Procedure (The SCRIPTS Study)
Canada108 participantsStarted 2018-09-07
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
Timeframe: 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.