- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03989518
The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction
연구 개요
상세 설명
The study takes part over three consecutive days, with fear conditioning to visual stimuli on day 1, imaginal extinction on day 2, and a fear reinstatement procedure, again to visual stimuli, on day 3. Skin conductance is used to measure fear responses.
Participants' are randomized to receive conditioning, extinction and reinstatement with either complex or simple stimuli. During imaginal extinction, imagery of each experimental stimulus is prompted through different verbal instructions.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Uppsala, 스웨덴
- Uppsala University, Departement of Psychology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Age 18 or over
Fluent in Swedish
Willing and able to provide informed consent and complete study procedures
Exclusion Criteria:
Current psychiatric disorder
Use of psychotropic medication within 6 months prior to study start
Receiving psychological treatment within 6 months prior to study start
Current neurological condition
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Simple stimuli
Two perceptually simple stimuli are used during all experimental phases (geometrical figures).
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Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
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실험적: Complex stimuli
Two complex stimuli are used in all experimental phases.
Stimuli consist of photographs of real objects of the same size and shape as the simple stimuli, but include perceptually more complex patterns, details and colors.
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Day 1. Participants are exposed to two different visual stimuli.
One of these stimuli is paired with a mild electric shock (i.e.
conditioned stimuli).
Day 2 (24 hours after Day 1).
Participants are exposed to mental imagery of the stimuli used during fear conditioning.
Imagery is prompted through different verbal instructions presented in a pseudo-randomized order.
No shocks are delivered.
Prior to imaginal extinction, participants receive task specific training.
Day 3 (48 h after day1).
Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2).
Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus.
No further shocks are delivered.
This procedure allows the study of long term effects of imaginal extinction.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Skin conductance response (SCR)
기간: Day 1
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SCR is used as a measure of physiological fear responses.
Differences in fear responses are used to assess fear learning during fear acquisition and to explore main effects and interactions between fear learning, stimulus complexity and capacity for mental imagery.
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Day 1
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Skin conductance response (SCR)
기간: Day 2 (24 h after day1)
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SCR is used as a measure of physiological fear responses.Differences in fear responses are used to assess fear reduction during imaginal extinction, and to explore main effects and interactions between fear reduction, stimulus complexity and capacity for mental imagery.
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Day 2 (24 h after day1)
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Skin conductance response (SCR)
기간: Day 3 (48 h after day 1)
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SCR is used as a measure of physiological fear responses.Differences in fear response are used to assess return of fear during reinstatement, and to explore main effects and interactions between return of fear, stimulus complexity and capacity for mental imagery.
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Day 3 (48 h after day 1)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fear ratings
기간: Day 1
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 1
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State-Trait Anxiety Inventory
기간: Day 1
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This is a self-rated questionnaire measuring trait anxiety.
Higher scores indicate higher level of trait-anxiety (range 20-80)
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Day 1
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Difficulties in emotion regulation scale
기간: Day 1
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This is a self-rated questionnaire measuring difficulties in emotion regulation.
Higher scores indicate higher level of difficulties in emotion regulation (range 36-180)
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Day 1
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Fear ratings
기간: Day 2 (24 h after day 1)
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 2 (24 h after day 1)
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Vividness of mental imagery during imaginal extinction
기간: Day 2 (24 h after day 1)
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Scale: 1-5; no image at all - image as clear and vivid as real life
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Day 2 (24 h after day 1)
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The Plymouth Sensory Imagery Questionnaire
기간: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring vividness of mental imagery across different sensory modalities.
Higher scores indicate higher level of vividness.
(range 0-70)
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Day 2 (24 h after day 1)
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The Vividness of Visual Imagery Questionnaire
기간: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring vividness of visual mental imagery.
Only eyes open section is administered.
Higher scores indicate higher level of vividness (range 0-80)
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Day 2 (24 h after day 1)
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Spontaneous use of imagery scale
기간: Day 2 (24 h after day 1)
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This is a self-rated questionnaire measuring spontaneous use of imagery.
Higher scores higher levels use of spontaneous use of imagery (range 12- 60)
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Day 2 (24 h after day 1)
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Expectancy ratings
기간: Day 2 (24 h after day 1)
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After the imaginal extinction procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
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Day 2 (24 h after day 1)
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Fear ratings
기간: Day 3 (48 h after day 1)
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Ratings of subjective fear during the experimental procedure.
Scale: 0 -100 (no fear at all - extreme fear)
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Day 3 (48 h after day 1)
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Expectancy ratings
기간: Day 3 (48 h after day 1)
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After the reinstatement procedure, participants are asked to rate to what extent they believed that electric shocks would be delivered during the procedure on a scale ranging from 0 - 100 %
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Day 3 (48 h after day 1)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Task compliance
기간: Day 1
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 1
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Task compliance
기간: Day 2 (24 h after day 1)
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 2 (24 h after day 1)
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Task compliance
기간: Day 3 (48 h after day 1)
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Questions asking participants to rate to what extent they followed the instructions during the experimental procedure on a scale ranging from 0 - 100 %.
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Day 3 (48 h after day 1)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2019-00524
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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