Development of a Scientifically-Informed Written Exposure Procedure (The SCRIPTS Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Standard Written Exposure
Four writing sessions at the laboratory
干预措施: Standard Written Exposure (Behavioral)
Enhanced Written Exposure
Four writing sessions at the laboratory
干预措施: Enhanced Written Exposure (Behavioral)
Control Condition
Four writing sessions at the laboratory
干预措施: Control Condition (Behavioral)
结局指标
主要结局
Change in self-reported past-week worry as measured by the Penn State Worry Questionnaire-Past Week Version
时间窗: 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.
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.
次要结局
- Self-reported maladaptive beliefs as measured by the Early Maladaptive Schema Questionnaire - Research version(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 mastery as measured by the Self-Mastery 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.)
- Fear and avoidance related to worst case scenario as measured by the Modified Behavioural Avoidance Test(Administered before the intervention on day 1 (pre-intervention) and 1-month follow-up.)
- Daily Worry and Emotion Questions(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.)
- 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.)
- Self-reported worry-related behaviours as measured by the Worry Behaviours Inventory(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 Perceived probability, cost and coping as measured by Perceived Probability, Cost and Coping questions(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.)
- 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 depression, anxiety and stress as measured by the Depression, Anxiety and Stress 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.)
研究者
Naomi Koerner
Associate Professor
Toronto Metropolitan University