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

NCT03654625 | Unknown

• 1 other identifier: REB 2018-094
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

Worry; Anxiety; Generalized Anxiety Disorder; Written Exposure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

  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

  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

  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

  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.

Study Arms (3)

Standard Written Exposure

EXPERIMENTAL

Four writing sessions at the laboratory

Behavioral: Standard Written Exposure

Enhanced Written Exposure

EXPERIMENTAL

Four writing sessions at the laboratory

Behavioral: Enhanced Written Exposure

Control Condition

PLACEBO COMPARATOR

Four writing sessions at the laboratory

Behavioral: Control Condition

Interventions

Standard Written Exposure BEHAVIORAL

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

Standard Written Exposure

Enhanced Written Exposure BEHAVIORAL

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

Enhanced Written Exposure

Control Condition BEHAVIORAL

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

Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Ministry of Research, Innovation and Science, Ontario: collaborator

Study Sites (1)

Ryerson University

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 24983797 BACKGROUND

Related Links

• Lab website

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Naomi Koerner, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi Koerner, PhD

CONTACT

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

Melina Ovanessian, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 31, 2018
• Study Start: September 7, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)