Clinical trial NCT03654625: Development of a Scientifically Informed Written Exposure Procedure (The SCRIPTS Study)
Official title: Development of a Scientifically-Informed Written Exposure Procedure (The SCRIPTS Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Excessive Worry
Keywords: Worry
Anxiety
Generalized Anxiety Disorder
Written Exposure
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Ministry of Research, Innovation and Science, Ontario
First posted: 2018-08-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: 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.
timeFrame: 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.
measure: Self-reported cognitive avoidance as measured by the Cognitive Avoidance Questionnaire
timeFrame: 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.
measure: Self-reported attitudes towards problems as measured by the Negative Problem Orientation Questionnaire
timeFrame: 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.
measure: Self-reported fear of emotions as measured by the Affective Control Scale
timeFrame: 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.
measure: Self-reported perceptions of shame as measured by the Shame-Aversive Reactions Questionnaire
timeFrame: 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.
measure: Self-reported maladaptive beliefs as measured by the Early Maladaptive Schema Questionnaire - Research version
timeFrame: 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.
measure: Self-reported worry-related behaviours as measured by the Worry Behaviours Inventory
timeFrame: 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.
measure: Self-reported mastery as measured by the Self-Mastery scale
timeFrame: 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.
measure: Self-reported Perceived probability, cost and coping as measured by Perceived Probability, Cost and Coping questions
timeFrame: 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.
measure: Fear and avoidance related to worst case scenario as measured by the Modified Behavioural Avoidance Test
timeFrame: Administered before the intervention on day 1 (pre-intervention) and 1-month follow-up.
measure: Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale
timeFrame: 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.
measure: Daily Worry and Emotion Questions
timeFrame: 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.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Naomi Koerner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.