Clinical trial NCT03950869: The Role of Expectations in the Development of Intrusive Memories
Official title: The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of three arms in parallel for the duration of the study.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency and severity of intrusive memories: Daily intrusion diary
timeFrame: Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.
Secondary outcomes:
measure: Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)
timeFrame: At the follow-up measurement (7 days after the experimental manipulation).
measure: Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)
timeFrame: At the follow-up measurement (7 days after the experimental manipulation).
Other outcomes:
measure: Appraisals of Intrusions Questionnaire
timeFrame: At baseline and the follow-up measurement (7 days after the experimental manipulation).
measure: Retrospective Assessment of Active Processing
timeFrame: At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.
Locations:
city: Marburg
country: Germany
facility: Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Eva-Lotta Brakemeier, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Philipps University Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.