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

Toronto Metropolitan University

Status: Unknown

Conditions: Excessive Worry

Treatments: Behavioral: Enhanced Written Exposure; Behavioral: Standard Written Exposure; Behavioral: Control Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT03654625

REB 2018-094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups, including a placebo group

Standard Written Exposure

Experimental group

Description:

Four writing sessions at the laboratory

Treatment:

Behavioral: Standard Written Exposure

Enhanced Written Exposure

Experimental group

Description:

Four writing sessions at the laboratory

Treatment:

Behavioral: Enhanced Written Exposure

Control Condition

Placebo Comparator group

Description:

Four writing sessions at the laboratory

Treatment:

Behavioral: Control Condition