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UnknownNCT03654625

Development of a Scientifically Informed Written Exposure Procedure (The SCRIPTS Study)

Development of a Scientifically-Informed Written Exposure Procedure (The SCRIPTS Study)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
108 (estimated)
Sponsor
Toronto Metropolitan University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALStandard Written ExposureFour spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry.
BEHAVIORALEnhanced Written ExposureFour spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry and rescript it.
BEHAVIORALControl ConditionFour spaced, 30-minute sessions occurring within a period of 2 weeks. At each session, participants write a narrative about a neutral topic.

Timeline

Start date
2018-09-07
Primary completion
2020-09-30
Completion
2020-12-31
First posted
2018-08-31
Last updated
2020-03-16

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03654625. Inclusion in this directory is not an endorsement.