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

Excessive Worry Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654625
• Other study ID #: REB 2018-094
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Ryerson University
• Contact: Naomi Koerner, PhD
• Phone: 416-979-5000
• Email: naomi.koerner[@]psych.ryerson.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Excessive Worry

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Ryerson University	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ryerson University	Canadian Institutes of Health Research (CIHR), Ministry of Research, Innovation and Science, Ontario

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Self-report measure of GAD symptoms. Fourteen items are summed to create a total score. Total scores range from 0 to 12, with greater scores indicating greater GAD symptom severity.	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.
Secondary	Self-reported cognitive avoidance as measured by the Cognitive Avoidance Questionnaire	Self-report measure of the tendency to engage in various cognitive avoidance strategies. Twenty-five items are summed to create a total score. Total scores range from 25 to 125, with higher scores indicating greater cognitive avoidance.	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.
Secondary	Self-reported attitudes towards problems as measured by the Negative Problem Orientation Questionnaire	Self-report measure of attitudes towards problems. Twelve items are summed to create a total score. Total scores range from 12 to 60, with higher scores indicating greater negative attitudes towards problems.	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.
Secondary	Self-reported fear of emotions as measured by the Affective Control Scale	Self-report measure of fear of emotions and attempts to control emotional experience. The scale contains 42 items divided into four subscales for distinct emotions: anxiety; depression; anger; positive emotion. Total scores range from 42 to 294; subscale scores range from 13 to 91, with higher scores indicating a greater fear of emotions.	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.
Secondary	Self-reported perceptions of shame as measured by the Shame-Aversive Reactions Questionnaire	Self-report measure of perception of shame as an undesirable and painful emotion. Fourteen items are summed to create a total score. Total scores range from 14 to 98, with higher scores indicating higher levels of shame aversion.	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.
Secondary	Self-reported maladaptive beliefs as measured by the Early Maladaptive Schema Questionnaire - Research version	Self-report measure of stable maladaptive beliefs. The scale contains 75 items divided into fifteen subscales for distinct maladaptive beliefs. Subscale scores range from 0 to 15, with higher scores indicating greater maladaptive beliefs.	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.
Secondary	Self-reported worry-related behaviours as measured by the Worry Behaviours Inventory	Self-report measure of worry-related behaviours. Ten items are summed to create a total score. Total scores range from 0 to 40, with higher scores indicating greater engagement in avoidant behaviors that are associated with worry.	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.
Secondary	Self-reported mastery as measured by the Self-Mastery scale	Self-report measure that assesses the extent to which an individual perceives a sense of personal control or mastery over life outcomes. Seven items are summed to create a total score. Total scores range from 7 to 49, with higher scores indicating greater personal control or mastery.	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.
Secondary	Self-reported Perceived probability, cost and coping as measured by Perceived Probability, Cost and Coping questions	Self-report measure of perceptions of probability and costliness of, and ability to cope with one's feared scenario. Three distinct questions assess each of the following perceptions related to feared scenarios: 1) Probability, 2) Cost and 3) Coping. Perceived probability scores range from 0 to 6 with higher scores indicating greater perceived likelihood of worst fears coming true. Perceived costliness scores range from 0 to 6, with higher scores indicating greater perceived costliness of worst fears. Perceived coping scores range from 0 to 6, with greater scores indicating greater ability to cope.	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.
Secondary	Fear and avoidance related to worst case scenario as measured by the Modified Behavioural Avoidance Test	Participants are asked to hold a mental image in mind of their hypothetical worst case scenario and rate their level of fear from 0 (no fear at all) to 10 (the most fear), and desire to avoid the mental image from 0 (no desire to avoid imagining) to 10 (the highest possible desire to avoid imagining).	Administered before the intervention on day 1 (pre-intervention) and 1-month follow-up.
Secondary	Self-reported depression, anxiety and stress as measured by the Depression, Anxiety and Stress Scale	Self-report measure that assesses depression, anxiety and stress symptoms over the past week. The scale contains 21 items, divided into three subscales: 1) Depression, 2) Anxiety and 3) Stress. Scores on the subscales range from 0 to 42, with higher scores indicating greater severity of depression, anxiety and stress.	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.
Secondary	Daily Worry and Emotion Questions	A daily self-report measure of (1) emotions, (2) worry controllability, (3) worry intensity and (4) worry duration.; Scores for the first three items range from 0 to 8, with higher scores indicating greater degree of emotions, worry intensity, and difficulty controlling worry. Worry duration is reported in minutes, with greater numbers indicating longer time spent worrying.	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.

External Links

•   Lab website