The Role of Expectations in the Development of Intrusive Memories

NCT ID: NCT03950869

Last Updated: 2021-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2019-12-31

Brief Summary

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In the experimental study, the well-established trauma film paradigm will be used to investigate the impact of expectations on the development of intrusive memories as a hallmark symptom of PTSD.

Detailed Description

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The study aims to examine the influence of different expectations on the development of intrusive memories by using a well-established experimental paradigm - the trauma film paradigm. In healthy volunteers, intrusion-like symptoms are to be induced with an analogue stressor, i.e., aversive film clip footage (trauma film). After viewing this so-called trauma film, the expectations of intrusions during the following week are manipulated by assigning participants randomly to three different groups. In the first group, negative expectations are induced (experimental group 1), the second group is exposed to positive expectations (experimental group 2) and a third group does not face any kind of manipulation of their expectations (control group). Participants are asked to report occurring intrusions in a diary during the following week and are invited to a subsequent cued laboratory inquiry at follow-up.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of three arms in parallel for the duration of the study.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Negative Expectations

Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.

Group Type EXPERIMENTAL

Negative Expectation Manipulation

Intervention Type BEHAVIORAL

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase negative expectations.

Positive Expectations

Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.

Group Type EXPERIMENTAL

Positive Expectation Manipulation

Intervention Type BEHAVIORAL

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase positive expectations.

No Expectation Manipulation

Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Positive Expectation Manipulation

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase positive expectations.

Intervention Type BEHAVIORAL

Negative Expectation Manipulation

Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase negative expectations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers
* fluent in German language

Exclusion Criteria

* history of traumatic experiences (LEC-5)
* presence of a mental disorder (SCID-I according to DSM-IV)
* cut-off in depression screening (PHQ-9)
* current suicidal thoughts/behavior or non-suicidal self-injury behavior (C-SSRS)
* medical history of heart disease or epilepsy
* history of fainting
* work experience in the medical field (e.g., nurses, paramedics, etc.)
* visual impairment
* students of psychology and medicine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva-Lotta Brakemeier, Professor

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Winfried Rief, Professor

Role: PRINCIPAL_INVESTIGATOR

Philipps University Marburg

Locations

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Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg

Marburg, Hesse, Germany

Site Status

Countries

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Germany

References

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Holmes EA, Bourne C. Inducing and modulating intrusive emotional memories: a review of the trauma film paradigm. Acta Psychol (Amst). 2008 Mar;127(3):553-66. doi: 10.1016/j.actpsy.2007.11.002. Epub 2008 Jan 29.

Reference Type BACKGROUND
PMID: 18234153 (View on PubMed)

James EL, Lau-Zhu A, Clark IA, Visser RM, Hagenaars MA, Holmes EA. The trauma film paradigm as an experimental psychopathology model of psychological trauma: intrusive memories and beyond. Clin Psychol Rev. 2016 Jul;47:106-42. doi: 10.1016/j.cpr.2016.04.010. Epub 2016 Apr 21.

Reference Type BACKGROUND
PMID: 27289421 (View on PubMed)

Iyadurai L, Visser RM, Lau-Zhu A, Porcheret K, Horsch A, Holmes EA, James EL. Intrusive memories of trauma: A target for research bridging cognitive science and its clinical application. Clin Psychol Rev. 2019 Apr;69:67-82. doi: 10.1016/j.cpr.2018.08.005. Epub 2018 Aug 23.

Reference Type BACKGROUND
PMID: 30293686 (View on PubMed)

Other Identifiers

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2019-07

Identifier Type: -

Identifier Source: org_study_id

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