Imagery Rescripting and Imaginal Exposure for Anxiety Symptoms: Mechanisms and Outcomes in a Large Analog Sample
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Change from baseline in the Social phobia inventory (SPIN)
研究概览
简要总结
This study will recruit 460 participants who self-report high symptoms of anxiety. Participants will be randomly assigned to one of 4 groups: one analog intervention of Imagery Rescripting (IR) for memories, an analog intervention of IR for future events, and analog intervention of Imaginal Exposure (IE) for memories and an analog intervention of IE for future events. We will examine the efficacy and mechanisms behind each intervention.
详细描述
After being informed about the study potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. They will be randomly assigned to one of four conditions (Imagery rescripting past; Imagery rescripting future; Imaginal exposure past; Imaginal exposure future) at a 1:1:1:1 ratio (n = 115 per group). Participant will be assigned using a variance minimization method that controls for between group variance in continuous and categorical variables- SPIN, ASI-3, OCI-R, GAD-7 and gender with a completely random assignment p random = .2 (for algorithm see Sella et al., 2018). Participants will attend three ~1.5 hour online ZOOM sessions (baseline-assessment and measurement, intervention, post assessment and measurement and follow-up measurement).
In this multiple baseline study, participant will enter the intervention phase either 7 or 14 days after the baseline stage.
Assessors will be blind to the treatment condition.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •We will recruit participants based on attainment of SPIN score >= 24 and/or ASI-3 scores >=23 and/or OCI-R subscale scores (not including hoarding subscale) >=6 and/or GAD-7 scores >= 9 .
排除标准
- •Diagnosis of psychosis, active suicidality, post-traumatic stress disorder, acute stress disorder. Can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions. Started/stopped taking psychotherapeutic medications in the last 3 months.
研究组 & 干预措施
Imaginal exposure for memories
A behavioral intervention in imagery for memories
干预措施: Imaginal exposure for memories (Behavioral)
Imaginal exposure for future events
A behavioral intervention in imagery for future events
干预措施: Imaginal exposure for future events (Behavioral)
Imagery rescripting for memories
A different behavioral intervention in imagery for memories
干预措施: Imagery rescripting for memories (Behavioral)
Imagery rescripting for future events
A different behavioral intervention in imagery for future events
干预措施: Imagery rescripting for future events (Behavioral)
结局指标
主要结局
Change from baseline in the Social phobia inventory (SPIN)
时间窗: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention)
The SPIN is a 17-item validated self-report instrument assessing sum of social phobia symptom intensity over the past week. Possible scores range from 0 (not at all) to 4 (Extremely). Sum scores range is 0-68. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Change from baseline in the Anxiety Sensitivity Index - 3 (ASI-3)
时间窗: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
The ASI-3 is an 18-item validated self-report instrument assessing sum of anxiety sensitivity symptom intensity over the past week. Possible scores range from 0 (not at all) to 4 (Very Much). Sum scores range is 0-72. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Change from baseline in the Obsessive-Compulsive Inventory Revised (OCI-R)
时间窗: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
The OCI-R is an 18-item validated self-report instrument assessing sum of obsessive-compulsive symptom intensity over the past week (Taylor et al., 2007). Possible scores range from 0 (not at all) to 4 (Extremely). Sum scores range is 0-72. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Change from baseline in the Generalized Anxiety Scale-7 (GAD-7)
时间窗: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
The GAD-7 is a 7-item validated self-report instrument assessing sum of generalized anxiety symptom intensity over the past week. Possible scores range from 0 (not at all) to 3 (Almost every day). Sum scores range is 0-21. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
Change from baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention)
The OASIS is a 5-item validated self-report instrument assessing sum of anxiety related symptoms, distress avoidance and functioning symptom intensity over the past week (Taylor et al., 2007). Possible scores range from 0 to 4. Sum scores range is 0-20. Change = 1: (post-intervention score - Baseline Score) 2: (Follow-up score - Baseline Score)
次要结局
- Change from Baseline in the Thought fusion inventory (TFI)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- Change from Baseline in the Thought Action Fusion scale - Revised (TAFS-R)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention))
- Change from Baseline to follow-up in the amount of negative and positive/neutral content details of the memory/future imagery(Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- The believability of the negative core-beliefs that the participant link to the negative imagery and memory provided in the WIMI(Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- imaginal Based Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination(Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- The Brief core schema scale (BCSS)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention))
- The Self compassion scale short (SCS)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention (7 days after the intervention) and Follow-up (28 days after the intervention))
- The impact of future events scale (IFES)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- The impact of events scale (IES)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- The distress tolerance scale (DTS)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- The experiences in close relationship scale short form (ECR-S)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- The short form of the metacognitions questionnaire (MCQ-30)(Will be measured at Baseline (7 or 14 days before the intervention), Intervention (immediately after the intervention), post-intervention ( 7 days after the intervention) and Follow-up (28 days after the intervention))
- The Beck cognitive insight scale (BCIS)(Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- Locus of control scale (LOC)(Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- Self-Appraisal of Illness Questionnaire (SAIQ)(Will be measured right before the Intervention, right immediately after the intervention, post-intervention ( 7 days after the intervention))
- Questionnaire implicit association task (qIAT)(Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- Paced visual serial addition test (PASAT)(Time Frame: Will be measured at Baseline (7 or 14 days before the intervention) and post-intervention ( 7 days after the intervention))
- Daily symptoms([Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)])
- Daily mechanisms([Time Frame: Daily, from Baseline to post-intervention (a total of 14, or 21 days)])
研究者
Jonathan D. Huppert
Professor
Hebrew University of Jerusalem