The Role of Expectations in the Development of Intrusive Memories

The Role of Expectations in the Development of Intrusive Memories: An Experimental Approach Using the Trauma Film Paradigm

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Negative Expectation Manipulation; Behavioral: Positive Expectation Manipulation

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Marburg, Hessen, Germany, 35032
      • Division of Clinical Psychology and Psychological Interventions, Department of Psychology, Philipps University Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Expectations; Expectations on the severity and frequency of intrusions are increased while expectations on the controllability of intrusions are decreased.	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.
Experimental: Positive Expectations; Expectations on the severity and frequency of intrusions are decreased while expectations on the controllability of intrusions are increased.	Behavioral: 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.
No Intervention: No Expectation Manipulation; Expectations on the severity and frequency of intrusions and on the controllability are neither increased nor decreased.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of intrusive memories: Daily intrusion diary	Participants are asked to complete a pen-and-paper diary 7 days in a row, reporting on intrusive memories in reference to the trauma film. They are asked to state the number of intrusions per day; each day of the diary is labeled and split into three sections (morning, afternoon, evening), and they are asked to mark in a box in the appropriate section when they experienced an intrusion. For each intrusion, they indicate the quality of the intrusion (image, thought or both), the intensity of and distress caused by the intrusion both on a scale ranging from 0 ("not at all") to 10 ("extremely"), the content of the intrusion, and the situation in which the intrusion occurred. Intrusive memory frequency across 7 days are calculated, whilst higher sum scores represent more intrusions. Severity of intrusions are calculated by combining the average score of the intensity and distress scale across all intrusions, whilst higher values indicate higher intensity/distress of reported intrusions.	Record of any intrusive memories of the trauma film content for Days 1 to 7 after the experimental manipulation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress caused by the trauma film: Impact of Event Scale-Revised (IES-R)	Participants are asked to respond 22 items in reference to the trauma film (e.g., "Pictures about the film popped into my mind.") by indicating how often each reaction occurred during the past seven days with respect to the film they watched last week. Items are rated on a 4-point-Likert-scale ranging from 0 ("not at all"), 1 ("rare"), 3 ("sometimes") to 5 ("often"). The IES-R consists of three subscales: "intrusion", "hyperarousal", and "avoidance". The total score (sum score for the total scale comprising the sum scores of all three subscales) is calculated ranging from 0 to 110 with higher values represent a worse outcome, i.e., higher total distress due to the trauma film in the past week. In addition, the sum score for the intrusion subscale is separately calculated ranging from 0 to 35 (Items 1, 3, 6, 9, 14, 16, 20) with higher values represent more intrusions due to the trauma film in the past week.	At the follow-up measurement (7 days after the experimental manipulation).
Laboratory assessment of intrusive memories: Intrusion Provocation Task (IPT)	In the Intrusion Provocation Task (IPT), participants are presented with a ten-second long neutral still image from each of the film clips. Immediately afterwards for the next two minutes, they are allowed to think freely and report intrusions by raising a finger. The investigator counts how often the participant lifts his finger in the two minutes. The IPT intrusion score is calculated by the total frequency of intrusions, whilst higher values represent more intrusions.	At the follow-up measurement (7 days after the experimental manipulation).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appraisals of Intrusions Questionnaire	The Appraisals of Intrusions Questionnaire is 25-item measure that assesses metacognitions of intrusive thoughts and memories. Participants rated the strength of each belief when they experienced their intrusive memories on a scale ranging from 0 (I didn't believe that at all.) to 100 (I was completely convinced that this was true.). Metacognitive appraisals are divided into four categories: "necessity of control", "external consequences", "psychological problem" and "negative self-evaluation". A total score is calculated, whilst higher values indicate more dysfunctional metacognitive beliefs.	At baseline and the follow-up measurement (7 days after the experimental manipulation).
Retrospective Assessment of Active Processing	Participants are asked in a self-report questionnaire to report for each day and each film clip the amount of time they spent actively processing the content of the film or intrusions associated to it, e.g., by intentionally thinking about it or by discussing it with other people. The participants are asked to rate how many minutes each day they have consciously dealt with the specific film clips or the memories of them. The scale ranges from 0 to 100 minutes in order to pre-define a lower and upper bound. The total score is calculated, whilst higher values indicate a better outcome.	At the follow-up measurement (7 days after the experimental manipulation) retrospectively on Days 1 to 7 after the experimental manipulation.

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Winfried Rief, Professor, Philipps University Marburg Medical Center; Principal Investigator: Eva-Lotta Brakemeier, Professor, Philipps University Marburg Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No