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临床试验/NCT04635904
NCT04635904招募中不适用

Imagery Based Interventions for the Treatment of Anxiety Related Disorders: Mechanisms and Optimizing Outcomes

Hebrew University of Jerusalem2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Change from baseline in the Social phobia inventory (SPIN) at the follow-up session

研究概览

简要总结

This study will recruit 100 participants who self-report high symptoms of social anxiety (Social phobia inventory >30). Participants will be randomly assigned to receive either one analog intervention of Imagery Rescripting (IR) or Imaginal Exposure. We will test the efficacy and mechanisms behind each interventions.

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 two conditions (Imagery rescripting Vs. Imaginal exposure) at a 1:1 ratio. Participants will attend three ~1 hour online ZOOM sessions (pre-assessment and measurement, intervention, and post assessment and measurement).

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)

盲法说明

Outcomes assessor that assess mental imagery content (see secondary outcomes) are blind to the condition.

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

入选标准

  • SPIN scores >= 30 -

排除标准

  • can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions.

结局指标

主要结局

Change from baseline in the Social phobia inventory (SPIN) at the follow-up session

时间窗: Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

The SPIN is a validated self-report instrument assessing average social phobia symptom intensity over the past week. possible scores range from 0 (not at all) to 4 (Extremly). change = (follow-up score - Baseline Score)

次要结局

  • Change from Baseline to follow-up in the amount of negative and positive/neutral content details the participant provides while describing the negative imagery. The imagery will be probed using the Waterloo Image and Memories Interview (WIMI).(Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention))
  • Change from Baseline to follow-up in negativity of the core-beliefs that the participant link to the negative imagery provided in the WIMI.(Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention))
  • The Patient's Experience of Attunement and Responsiveness Scale (PEAR) measures participants' feelings of acceptance by the intervention and interview providers(Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention))
  • Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session(Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention))
  • Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session(Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention))
  • Change from Baseline in the Positive and Negative Affect Scale (PANAS) international version short form (10 items from the negative subscale only) at the follow-up session(Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention))
  • Sentence Completion Task (SCT). Measures participants automatic interpretation bias while being presented with 10 ambiguous social scenarios.(Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention))
  • The Brief core schema scale (BCSS) measures participants' self beliefs about themselves and others.(Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention))
  • Change across time in the Mini Social phobia inventory - revised (mini SPIN-R) from baseline to pre-treatment and from pre-treatment to follow-up.(Daily, from Baseline to follow-up (a total of 14, 17, or 20 days))
  • Daily questionnaire about negative intrusive imagery in general and specific to the imagery provided in the interview.(Daily, from Baseline to follow-up (a total of 14, 17, or 20 days))
  • imaginal Behavioral Approach Test (iBAT) that measures the participant's willingness to interact with pre-scripted distressing scenarios in imagination(Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan D. Huppert

Professor, PhD, Certified Clinical Psychologist

Hebrew University of Jerusalem

研究点 (2)

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