Recruiting

Observational Study

Sponsor:

Toronto Metropolitan University

Code:

NCT03654625

Conditions

Excessive Worry

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard Written Exposure

Enhanced Written Exposure

Control Condition

Study Details

Brief 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.

Conditions

Excessive Worry

Study ID

NCT03654625

Start date

Sep 7, 2018

Status verified date

Mar, 2020

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Sep 30, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard Written Exposure

Four writing sessions at the laboratory

experimental: Enhanced Written Exposure

Four writing sessions at the laboratory

placebo comparator: Control Condition

Four writing sessions at the laboratory

Interventions

Standard Written Exposure

Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry.

Enhanced Written Exposure

Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry and rescript it.

Control Condition

Four spaced, 30-minute sessions occurring within a period of 2 weeks. At each session, participants write a narrative about a neutral topic.

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. ]

Central Contacts and Locations

Central contacts

Naomi Koerner, PhD

416-979-5000naomi.koerner@psych.ryerson.ca

Melina Ovanessian, MA

416-979-5000movaness@psych.ryerson.ca

Locations

Ryerson University

Recruiting

Toronto, Ontario, Canada, M5B 2K3

Contacts

Naomi Koerner, PhD

416-979-5000naomi.koerner@psych.ryerson.ca

More Information

Sponsor

Toronto Metropolitan University

Last update posted

Mar 16, 2020

Last verified

Mar, 2020

Keywords

  • Worry
  • Anxiety
  • Generalized Anxiety Disorder
  • Written Exposure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Metropolitan University on 2020-03-16.